- Email: [email protected]
Endoscopic suturing
Best Practice & Research Clinical Gastroenterology Vol. 18, No. 1, pp. 37–47, 2004 doi:10.1053/ybega.2004.421, available online at http://www.sciencedirect.com
3 Endoscopic suturing Paul Swain*
MD
Professor Department of Medical Physics, University College London, 11 –20 Capper Street, London WCI, UK
Per-Ola Park
MD
Consultant Surgeon Department of Surgery, Sahlgrenska University Hospital/O¨stra, S-216 85 Gothenburg, Sweden
We describe the development of endoscopic sewing machines and ancillary equipment for knot tying and thread cutting. We outline the experimental studies in dogs, pigs and baboons prior to the first studies in man. We consider the early results achieved by groups in Europe and the U.S.A., and present the available evidence from peer-reviewed studies and data from numerous abstracts on the use of endoscopic suturing in man for treating gastro-oesophageal reflux. We consider the limitations of the available studies, and outline the requirements for improvements in flexible endoscopic suturing methods. Key words: reflux; sewing; suturing; oesophagus; stomach; endoscopy.
Some patients with gastro-oesophageal reflux disease (GORD) have troublesome symptoms which respond poorly to treatment with proton pump inhibitors or other drugs. Others do not want to take medications long term. The medical costs of treating reflux are high and if surgery was effective, safe and inexpensive it might be very cost effective. Long-term acid suppression in any case is not a very logical treatment for GORD, which is not due to excessive acid production but is, in general, due to failure of a valve which normally keeps acid out of the oesophagus. Although laparoscopic or open surgical operations—such as Nissen fundoplication for reflux—seem effective in skilled hands, there are drawbacks to surgery. The complications include impairment of swallowing, diarrhoea, gas bloat, vagotomy, oesophageal perforation, large-vessel bleeding and a small mortality rate. Failures also occur due to wrap disruption, slippage of the wrap and hernia recurrence and poor case selection. There are patients with medical problems and severe reflux in whom the risks of an anaesthetic and pneumo-peritoneum during laparoscopic surgery seem a poor option. Occasional patients are seriously disadvantaged by attempts at reflux surgery. Revision surgery (redo) is associated with a further substantial increase in the chances of morbidity and failure. * Corresponding author. E-mail address: [email protected] (P. Swain). 1521-6918/04/$ - see front matter Q 2003 Elsevier Ltd. All rights reserved.
38 P. Swain and P.-O. Park
A safer, less invasive, effective method for treating reflux using flexible endoscopes passed though the mouth without entering the peritoneal cavity might have advantages for patients who are unsatisfied with medical therapy or who want to stop taking drugs. This presentation outlines the evolution, past, present and possible future of flexible endoscopic treatment using endosurgical sewing techniques for GORD.
THE DEVELOPMENT OF THE ENDOCINCH AND ASSOCIATED DEVICES Devices developed for the Endocinch kit include: sewing machines, tag and thread, devices for tying knots or locking thread, thread-cutting devices and a combination device for attaching the sewing machine body to the endoscope and to assist in loading the threaded tag into the hollow needle. Sewing machines The current Endocinch device is closely based on the fourth flexible endoscopic sewing device to be designed, patented and built by our group in the medical engineering department at University College Hospital and tested in the Royal London Hospital. Our collaborators in this development were Tim Mills and Geoff Brown—a physicist and an engineer, respectively. I would like to acknowledge my great debt to and pleasure working with them over the last 20 years (PS). The first two sewing devices1,2 Our first two sewing devices both used suction into a cavity in order to control the depth and length of the stitch, as in the current Endocinch device, but were designed to place multiple stitches in gastrointestinal tissue. They both used a needle with an eye close to the tip and a swinging catch mechanism and were closer to the design of household sewing machines. The ability to place multiple stitches in tissue quickly and without withdrawing the endoscope remains a highly desirable function to which future endoscopic sewing machine designs will have to return (Table 1). Table 1. U.S.-issued patents related to the EndoCinch endoscopic suturing device. Title Sewing machine Sewing machine Sewing device Device used in securing a thread Device for use in cutting threads Sewing device Control handle for an endoscope Device for use in tying knots Device for use in tying knots
Patent number
Date of issue
4,841,888 5,037,021 5,080,663 5,584,861 5,755,730 5,792,153 5,901,105 6,010,515 6,358,259
Jun 27, 1989 Aug 6, 1991 Jan 14, 1992 Dec 17, 1996 May 26, 1998 Aug 11, 1998 Jun 8, 1999 Jan 4, 2000 Mar 19, 2002
Endoscopic suturing 39
The third sewing device3 The third device we constructed employed a hollow needle with a slot and a rod to force a tag through the needle once it had penetrated tissue, which remains the basic stitch action of the Endocinch. Unlike the later commercially developed device, the needle was pulled rather than pushed, which required a longer rigid head. It was designed to deliver a payload which could be stitched to the deep muscle layer of the stomach. Initially it was used to sew radio-telemetry pH and pressure capsules to the stomach and oesophagus. This sewing device was the first to be used in man. A radiotelemetry pH capsule was sewn into the cardia of a volunteer (PS) and several patients and it transmitted pH data for a period of 5 months before the battery ran out and the capsule was subsequently removed from the stomach once the attachment thread was cut. This third device incorporated several of the features now found in the Endocinch, which was our fourth endoscopic sewing device. A re-design was undertaken to try to improve and simplify the mechanism of sewing. Tag and thread The plastic tag as used in the third machine was changed to a hollow metal tag so that a length of nylon 3.0 thread could be attached to it and used to form the stitch. The tag was improved by making a cut in one end. The tag could be widened to exert a springlike frictional force when it was inside the needle. This mechanism prevented the tag and thread from dropping out prematurely, which had been a problem during the early live experiments. The fourth device which remains the basic design for the Endocinch2 We decided to try to design the smallest, simplest method for placing a full-thickness stitch in human gastric tissue, which could be mounted on a conventional flexible endoscope. We concentrated on designing the sewing suction capsule so that it was as short as possible and also had the smallest cross-sectional area, which would allow the needle to penetrate all the layers of the tissue to place a stitch. The machine was extensively altered following tests in post-mortem human gastric tissue to get these dimensions right. We had excellent links with our pathology department where many post-mortem examinations were being performed. It has recently become much more difficult to get access to human post-mortem tissue for this type of work. Porcine stomach is easier to acquire and keeps well frozen, but the deep muscle is much thicker in a 70 kg animal when compared to a human of the same weight and the mucosa is tougher and less vascular. A stomach from a 20 – 30 kg pig is more similar to an adult human stomach. In order to shorten the rigid length of the sewing machine we decided to try to push rather than pull the needle. The force that can be exerted by pushing a catheter through the biopsy channel of an endoscope is surprisingly low as we found out when we constructed the first flexible endoscopic stapling device.4 It is difficult but possible to push the current 17 gauge needle as used in the Endocinch, mounted on a wire-wound coil catheter, through the stomach wall through an endoscope freehand. We found that if the tissue is constrained by suction within a cavity this splints the tissue to allow penetration by the needle. The mechanical force exerted was improved by using a wire-wound coil, which was strong in compression attached to the needle. A low-friction plastic coating and a smooth fit to reduce lateral forces impinging on
40 P. Swain and P.-O. Park
the wall of the biopsy channel helped. The exit hole dimensions and shape were found by trial and error. If the hole was too large tissue was dragged into the exit hole and increased the force exerted on the needle preventing passage. When the exit hole was made too small, the needle and thread would strike the anvil rather than the hole. We found that we had to prevent needle rotation because the thread could wind around the needle, altering drag and penetration diameter. Initially a pin was used which located in the longitudinal slot of the needle to prevent rotation. A later modification by Bard altered the needle shape from a circular shape into a D configuration and the metal sleeve was similarly altered to prevent needle rotation. The catch mechanism, which now seems an obvious idea, was in fact arrived at by trial and error. At first, we thought that we would push a tag attached to a thread through a full-thickness double layer of tissue and release the tag on the far side. We thought it would then be possible to grab the thread with flexible biopsy or grabbing forceps and pull it back to re-load the thread. We made the end-cap first as a shield to prevent the needle entering tissue again and injecting the tag into submucosal tissue after it had penetrated the desired double layer of tissue. Our first end-caps had a side hole to allow the tag to fall out. When we came to use this in live experiments the tag occasionally became caught in the end-cap and it became apparent that if there were no hole we could pull the thread back to the mouth without having to attempt to grab the tag with forceps. We had to design the machine so that it did not interfere with the visual, washing and inflating function of available endoscopes but allowed us to get good depth of tissue penetration given the eccentrically place position of the biopsy channel through which the needle passed. We elected to take the suction tubing coaxially, external to the endoscope so that we could use the machine with most conventional endoscopes. The tubing was chosen so that it does not collapse if the suction pressure is high and will resist kinking. We studied several different ways of ensuring that the suction pressure was applied in such a way that the cavity in the body was completely filled with tissue. The current design with side holes in a rigid suction tube in the floor of the suction cavity was simple to make and outperformed more complex designs. The length the needle has to pass beyond the tissue before the tag can be reliable ejected, and the length that the pushing rod has to pass beyond the tip of the needle, were also found by trial and error (mostly error). Repeated miss-firings were eventually found to be due to variations of needle and pushing rod length when the endoscope tip was flexed. We were surprised to find that there was a 3 mm difference in emergence of the needle and pushing rod comparing the curved and straight endoscope positions. It was necessary to design the system so that the needle and pushing rod passed further out, which allowed for extra play in this flexible system. The sewing machine body design dimensions and basic mechanism of sewing action have changed little in subsequent modifications of Endocinch. This fourth device was constructed and used in patients before it was taken over and further developed by Bard. Knot tying5 We developed three knotting processes, all of which have been subsequently used in the Endocinch kits. The first we made was a simple cylindrical ring which could be press fitted onto the end of the endoscope. It had two holes on either side through which thread could pass. A half hitch was tied outside the mouth, the threads passed through the two holes and the knot was pushed down to tissue. This was the first to be used in man. It was the second to be used in a modified form in the Endocinch kit. We then made a knot pusher, which was attached to a wire-wound cable so that it could be pushed
Endoscopic suturing 41
backwards and forwards beyond the tip of the endoscope. It had to be back-loaded over a guide-wire up the biopsy channel of an endoscope. It contained a viewing hole, which allowed the knot to be kept in view as a half hitch was pushed down to tissues. This device has tied most of the knots in the earlier human studies. We also developed a collet and sleeve (pin and cylinder method) to lock the thread. Extensive testing with an Instron—which is a device which we used to measure the forces as knots are pulled apart—showed that all of these three knotting methods used at flexible endoscopy could perform as well as hand-tied surgical knots. Recently, Bard have further developed the cylinder-and-pin method way beyond our design; they have made it very small and designed it to cut the thread once the thread has been secured. This is the knotting mechanism incorporated in their current kit. Although it is occasionally a little fiddly to load and to pull the thread through the pin it has the advantage that it is very fast to fire and cut the thread and substantially reduces the number of times the endoscope has to go in and out of the oesophagus. This advance has made it possible to do the whole procedure without using an over-tube. Cutting thread6 Cutting thread was initially accomplished in the first human cases with the use of an Olympus stitch cutter. It was very difficult to cut the thread by simply passing the thread cutter through the biopsy channel because the thread and the cutter lay in the same axis in the oesophagus. We found that if the thread were passed through a gap in the Olympus thread cutter, which was then run down over the thread, it was possible to cut the thread using the thread as its own guide. The cutters had to be passed down to the cardia open and the thread would cut only if placed against the correct blade. We subsequently designed the thread-cutting guillotine, which has been used for most of the human cases. It was only in bench testing using an oesophagus, stomach and over-tube that it became apparent that the guillotine was much faster and more reliable than any other method. A guillotine action has been incorporated into the latest pin and sleeve method for securing thread. A single action cuts the thread and releases the ‘knot’. A guillotine action was included in the current smalldiameter knotting device, which reduced the number of passes required to complete a stitch. A presentation of our work in progress at a British Society of Gastroenterology (BSG) meeting in Dublin in 1993 caught the eye of the BBC news, which had been sent a copy of the programme. The work was little regarded by the BSG, which had awarded it a poster presentation. The BBC programme was shown in most countries of the world and many patients approached us to have the procedure done. With the enthusiastic support of this first cohort of patients who found us we prepared to undertake the first patient studies. Ethical committee approval was sought and granted. Several patients had already been treated before Bard agreed to take on the device and develop what later became the EndoCinch. Per-Ola Park, who is a surgeon in Sweden, became interested and visited London and invited Paul Swain to Va¨xjo¨ on several occasions to assist with the procedures. Per-Ola Park uses two video systems so that the two endoscopes used for the procedure do not have to be unplugged and then plugged into the same videoprocessor and trained his assistants to have the knot-tying device loaded while the endoscopist is placing the stitches. We have both changed from an improvized method with gathering tags for re-use and tying thread to using the kits provided (but hoarding sterile spare threads and knot-tying components for use in experiments or to place extra stitches in patients if necessary).
42 P. Swain and P.-O. Park
The Endocinch device has been used mainly to treat GORD.7 It has also been used to close oesophageal and gastric perforations and attach pH radio-telemetry capsules to the oesophagus, stomach and duodenum and attach feeding tubes to the stomach wall. Endoscopic gastroplasty is a minimally invasive surgical procedure for gastrooesophageal reflux, which has been performed at flexible endoscopy without laparotomy or laparoscopy.7 This operation is similar to a Collis’ gastroplasty, which was initially developed as a method for treating ‘short oesophagus’ which may be a synonym for, or equivalent to, a Barrett’s oesophagus.8 Other reflux procedures performed using the Endocinch We examined a reflux procedure, which more closely resembled a Nissen fundoplication.7 The operation involved stitching through the oesophagus to form the wrap and required more stitches. We elected to start in humans with the simplest, safest and quickest operation which gave good results in the animal studies. It seems feasible to achieve a closer approximation to a Nissen-like wrap endoluminally but the tools are not yet available to do this. Variant gastroplasty techniques have been described using the Endocinch device. Filipi randomized a circumferential stitch configuration to a longitudinal in a multi-centre American study. There were no significant differences between these configurations. Others, especially Raijman and Chen, have developed a helical technique. More information is needed from comparative methods to optimize the stitch position and numbers of stitches. Conical valve prosthesis attachment9 A light tubular prosthetic valve formed in the shape of a conical tube was developed in Switzerland. This has been sewn to the cardio-oesophageal junction and shown to produce an increase in lower oesophageal sphincter length of 7 cm (the length of the valve) in pigs. It did not alter the lower oesophageal sphincter pressure. This device has been tested in a few patients with reflux. Clinical results with endoscopic gastroplasty Promising results have been reported in both European10 and American11 series using endoscopic sewing machine technology. The results of endoscopic gastroplasty suggest that this operation can improve reflux symptoms and measured acid exposure of distal oesophagus and increase lower oesophageal sphincter length and pressure. These results were observed in 142 patients with GORD.12 Symptoms assessed by DeMeester score improved from a median of 5 to 1 (P , 0:05). Median lower oesophageal sphincter length increased from 2 to 3 cm (P , 0:05) and pressure increased from 5 to 8 mmHg (P , 0:05). Median % time pH , 4 decreased from 8.4 to 2.7 (P , 0:05). Good symptomatic results were obtained with endoscopic gastroplasty in 64 patients in a multi-centre American study.11 Half the patients had stitches placed below the cardio-oesophageal junction in a linear configuration and the other half in a circumferential configuration. Patients with hiatus hernia . 2 cm and with Barrett’s oesophagus were excluded from this study. Sixty-two percent of patients experienced success at 3 months. Heartburn scores improved from 62.5 to 16.6, heartburn severity improved from 22.8 to 9.2 and regurgitation from 1.8 to 0.6. All of these end-points
Endoscopic suturing 43
were highly significant (P , 0:0001). Patients with acid exposure , 10% had a significant improvement in % time pH , 4, P , 0:002: Complications were relatively uncommon and included bleeding, over-sedation and a single perforation. Dysphagia appeared less common than with Nissen fundoplication. The procedure does not prevent or make subsequent surgery more difficult. Most patients went home within a few hours of the procedure and were able to work the day after the procedure. There are now a number of studies which assess and, in general, support the value of endoluminal suturing as a means of treating reflux. Rothstein’s excellent recently published monograph13 in Gastrointestinal Endoscopy Clinics of North America reviews most of the flexible endoscopic methods and gives a good account of the reported trials using the Endocinch device.14 He concludes ‘the BARD EndoCinch procedure seems safe and demonstrated an acceptable efficacy for symptom control during short-term follow-up’. Fennerty has contributed a cool and cautious review of the current available evidence15 in Gastrointestinal Endoscopy. He suggested that, at this time, only an indeterminate recommendation for EST (endoscopic suturing therapy) as a treatment for GORD can be given. He concluded by suggesting that possible future indications for EST might be: (1) as primary therapy for GORD in patients desiring nonpharmacological or surgical therapy, (2) as an adjunctive or salvage therapy for GORD to (a) decrease medication requirements or (b) improve medical or surgical response. It is quite hard to summarize the results achieved to date by reviewing the several studies mostly in abstract form.11,16 – 33 Only two peer-reviewed studies have been published in full to date.11,21 Most studies appear to show substantial symptomatic improvement and significant reduction in the use of proton pump inhibitor medications. For example, 10/10 studies published in abstract form reported statistically significant improvement in heartburn symptom scores in a follow-up of 3 –12 months.11,16 – 18,20 – 24,29 Seven of seven studies reported significant improvement in regurgitation frequency scores. All studies reported a reduction in medication use; 20 –76% were completely off proton pump inhibitor (PPI) treatment at 3 –12 months. Nine of ten studies showed a significant reduction in oesophageal 24-hour pH exposure: refs 11,16 –18,20,21,23,24,29/ref. 22. Four of eight studies showed a significant effect on lower oesophageal sphincter pressure and/or length: refs 16,17,27, 29/refs 11,20 – 22. One study showed that transient lower oesophageal sphincter relaxations are reduced by endoscopic gastroplasty.27 Some groups have examined cost effectiveness. Chen et al18, for example, reported that 183 patients studied 12 months post-endoluminal gastroplication reported significant improvements in heartburn and regurgitation, while noting substantial costsavings due to the elimination or reduction of GORD prescriptives, especially PPIs (P . 0:0001). Pre-ELGP annual drug costs of $2379 compared to $351 at 12 months following ELGP (P , 0:0001)—an average annual drug cost-savings of $2028. Annualized medication costs in a study by Raijman et al were $2836 before ELGP, $327 after EGLP.19 There is of course a paucity of data on longer-term outcomes. Significant improvement in heartburn severity and frequency scores were reported in two studies. About 25% were completely off PPI therapy and another third to a half were taking less than half their original dose.28,31 The first 14 patients treated for GORD in Va¨xjo¨ have been followed for 4 years. Four out of the 14 patients were failures and have later been operated with NissenRosetti fundoplication wihtout any complications. Seven of the remaining patients have
44 P. Swain and P.-O. Park
been followed-up with 24-hour pH monitoring and interviews. The median preoperative Demeester score was 7 and after 4 years it was 3. The patients were taking PPIs daily before the gastroplasty and after the 4 years four patients were still off PPIs and the other three patients needed PPIs only two or three times a week. The median 24-hour pH value was 6.8% prior to the gastroplasty and was 5.2% at 4 years after the procedure. An Irish study has shown that the clinical results in reducing heartburn are almost as good as those achieved by Nissen fundoplication but with a lower complication rate and cost.30 Some studies have examined variation in pattern and number of stitches. Filipi and colleagues compared a linear with a circumferential stitch configuration.11,33 There were no significant differences but the linear configuration was a little ahead. In our own experiments in pigs (25 kg), there was a twofold and significant increase in yield pressure after one plication. After two plications the yield pressure increased 2.5 times compared with controls (no sutures). We were not able to show any difference between circumferential and linear configurations. Raijman et al have popularized a helical configuration.17 Lehman and colleagues have suggested that the addition of cautery may enhance stitch survival.25 Our group suggested avoiding patients with hiatus hernias larger than 2 cm in size because our results were less good; with these patients this exclusion criterion has been included in most subsequent trials of endotherapy for GORD.11 Raijman et al have suggested that good results can be obtained in patients with large hernias but that more stitches may be required.19 One series has suggested that patients with reflux-related pulmonary complications can be improved by this procedure.32 A study from the U.K. has shown that endoscopic suturing with the Bard device can produce good results in children with reflux and can normalize pH values in most patients.34 There is, of course, room for improvement. More work is needed to make endoscopic suturing easier, quicker and more reliable. In our view the single most important next goal is to construct a device which can place multiple stitches without the need to remove the endoscope between each stitch. Devices which can place two stitches in one go would be a start. We have reported the development of double stitch as well as multiple-stitch devices.35 We were pleased to see two alternative commercial endoscopic sewing devices appear at the last DDW, one from NDO36,37 and the other from Wilson Cook38, which place two but not more stitches without needing to withdraw the endoscopes—both use a double-needle method. All the above anti-reflux devices are limited in that they can apply stitches only to the gastric cardia or oesophagus but cannot vary or view the depth of stitch placement; neither can they return the lower oesophageal sphincter to a subdiaphragmatic position if the sphincter has migrated upwards. They cannot repair a hiatus hernia if present and they do not attach the stomach to other abdominal structures. Experimental studies in pigs using endoscopic ultrasound and modified needles have allowed suturing at flexible endoscopy.39 Two procedures have been studied.40 The first is a posterior gastropexy, which is the basis of a Hill repair in which stitches are placed though the wall of the stomach into the median arcuate ligament. The second involves placing stitches into the right crura in order to ‘reduce’ a hiatus hernia. These studies at least suggest that endoscopic suturing could undergo substantial further development in different directions before a standard technique emerges.
Endoscopic suturing 45
CONCLUSION Most reviews on this and other topics tend to close by suggesting that more studies are needed; that randomized studies and sham studies should be performed and that more long-term follow-up data would help. Although such conclusions are valid, they miss the point that these suturing techniques are in their infancy. It is important, of course, that some studies at this stage should show that reasonably promising results have been obtained with existing equipment. There is currently a much greater need for better engineering solutions than for better clinical studies. Improvements are needed as follows. Stitches should be placed to a predetermined depth, probably in the muscularis propria or perhaps through to the serosa. Multiple stitches need to be placed with the knot tied without having to withdraw the endoscope and re-load thread, tie knots or add fixation devices. The device should preferably determine the gap between the stitches as well as the tension on the tissue. It is thinkable to develop a flexible endoscopic method which could use sutures to treat reflux in a standardized procedure requiring minimal skill and take less than 5 minutes to complete. Practice points † † † † † † † † †
mechanisms of sewing machine action for use at flexible endoscopy evolution of sewing machines development and mechanism of action of three knotting methods development of cutting methods with scissors and guillotines experimental studies and types of endoluminal flexible endoscopic anti-reflux operations early clinical studies review of recent studies and clinical outcomes new suturing methods transluminal endoscopic ultrasound surgery for reflux
Research agenda † † † †
new-action sewing machines faster sewing machines multiple-stitch sewing machines suturing at endoscopic ultrasound (posterior gastropexy and hiatus hernia repair) † need for better understanding of the physiology of reflux † need for better clinical data with randomized or sham studies † main need is for more engineering input to simplify the procedure
REFERENCES * 1. Swain CP & Mills TN. An Endoscopic sewing machine. Gastrointestinal Endoscopy 1986; 32: 36–37. * 2. Swain CP. Endoscopic sewing and stapling machines. Endoscopy 1997; 29: 205–210. * 3. Swain CP, Brown G, Gong F & Mills TN. An endoscopically deliverable tissue transfixing device for securing biosensors in the gastrointestinal tract. Gastrointestinal Endoscopy 1994; 40: 730–734.
46 P. Swain and P.-O. Park * 4. Swain CP, Brown G & Mills TN. An endoscopic stapling device: development of a new flexible endoscopically controlled device for placing multiple transmural staples in gastrointestinal tissue. Gastrointestinal Endoscopy 1989; 35: 338–339. * 5. Swain CP, Kadirkamanathan SS, Gong F et al. Knot tying at flexible endoscopy. Gastrointestinal Endoscopy 1994; 40: 722 –729. * 6. Gong F, Swain P, Kadirkamanathan S et al. Cutting thread at flexible endoscopy. Gastrointestinal Endoscopy 1996; 44: 667 –674. * 7. Kadirkamanathan SS, Evans DF, Gong F et al. Antireflux operations at flexible endoscopy using endoluminal stitching techniques: an experimental study. Gastrointestinal Endoscopy 1996; 44: 133–143. 8. Collis JL. An operation for hiatus hernia with short esophagus. Journal of Thoracic Surgery 1957; 34: 768–778. 9. Godin NJ, Swain CP, Gong F et al. Endoscopic suturing of a novel gastro-esophageal antireflux device (GARD): a preliminary report. Gastrointestinal Endoscopy 1996; 43: 336. 10. Swain CP, Park PO, Kjellin T et al. Endoscopic gastroplasty for gastro-esophageal reflux disease. Gastrointestinal Endoscopy 2000; 51: AB144. (abstract). 11. Filipi CJ, Edmundowicz SA, Gostout CJ et al. Transoral endoscopic suturing for gastro-esophageal reflux disease: a multicenter trial. Gastrointestinal Endoscopy 2000; 51: AB143. (abstract). * 12. Filipi CJ, Lehman GA, Rothstein RI et al. Transoral, flexible endoscopic suturing for treatment of GERD: a multicenter trial. Gastrointestinal Endoscopy 2001; 53: 416–422. 13. Rothstein RI. Endoscopic therapy for gastroesophageal reflux disease. Gastrointestinal Endoscopy Clinics of North America 2003; 13: 1–226. * 14. Rothstein RI & Filipi CJ. Endoscopic suturing for gastroesophageal: clinical outcome with the Bard EndoCinch. Gastrointestinal Endoscopy Clinics of North America 2003; 13: 89–101. * 15. Fennerty MB. Endoscopic suturing for treatment of GERD. Gastrointestinal Endoscopy 2003; 57: 390–395. 16. Swain CP, Kadirkamanathan SS, Gong F et al. Endoscopic gastroplasty for gastroesophageal disease (abstract). Gastrointestinal Endoscopy 1997; 47: AB85. 17. Raijman I, Ben-Menachem T, Reddy G et al. Symptomatic response to endoluminal gastroplication (ELGP) in patients with gastroesophageal reflux disease: a multi-center study. Gastrointestinal Endoscopy 2001; 53: AB74. abstract 738. 18. Chen YK, Raijman I, Ben-Menachem T et al. One-year follow-up of endoluminal gastroplication: clinical and economic outcomes of the U.S. multicenter trial. Gastrointestinal Endoscopy 2002; 55. abstract M1887. 19. Raijman I, Ben-Menachem T, Starpoli AA et al. Endoluminal gastroplication improves GERD symptoms in patients with large hiatal hernia. Gastrointestinal Endoscopy 2002; 55. abstract AB 255. 20. Caca K, Schiefke J, Soder H et al. Endoluminal gastroplicaiton (Endocinch) in GERD patients refractory to PPI therapy. Gastrointestinal Endoscopy 2002; 55. abstract AB257. 21. Mahmood Z, McMahon BP, Arfin Q et al. Endocinch therapy for gastro-oesophageal reflux disease: a one year prospective follow up. Gut 2003; 52: 34–39. 22. Lui J, Knapp R & Carr-Lock D. Treatment of medication refractory gastroesophageal reflux disease with endoluminal gastroplication. Gastrointestinal Endoscopy 2002; 55. abstract AB252. 23. Abdu-Rebyeh H, Hoepffner N, Osmanoglou E et al. Endoscopic suturing is able to reduce pathological acid reflux in gastroesophageal disease. Gastrointestinal Endoscopy 2002; 55. abstract 259. 24. Arts J, Sloomaekers S, Sifrim D et al. Endoluminal gastroplication (Endocinch) in GERD patients refractory to PPI therapy (abstract). Gastroenterology 2002; 122: AB391. 25. Lehman GA, Dunne DP, Heiston K et al. Suturing plication of cardia with Endocinch device: effect of supplementary cautery. A human prospective trial (abstract). Gastrointestinal Endoscopy 2002; 55: AB260. 26. Raijman I, Ben-Menachem T, Reddy G & Chen Y. Symptomatic response to endoluminal gastroplication (EGLP) in patients with gastroesophageal reflux disease: a multi-center study (abstract). Gastrointestinal Endoscopy 2001; 53: 74. 27. Tam W, Holloway R, Dent J et al. Impact of endoscopic suturing of the gastroesophageal junction on lower esophageal sphincter function and gastroesophageal reflux in patients with reflux disease (abstract). Gastroenterology 2002; 122: AB390. 28. Rothstein RI, Pohl H, Grove M et al. Endoscopic gastric plication for the treatment of GERD: two year follow-up results (abstract). American Journal of Gastroenterology 2001; 96S: 107. 29. Swain CP, Park PO, Kjellin T et al. Endoscopic gastroplasty for gastro-oesophageal reflux disease (abstract). Gastrointestinal Endoscopy 2001; 51: 144. 30. Mahmood Z, Byrne PJ, McCullough J et al. A comparison of Bard Endocinch transesophageal endoscopic plication (BETEP) with laparoscopic Nissen fundoplication (LNF) for the treatment of gasto-esophageal reflux disease (abstract). Gastrointestinal Endoscopy 2002; 55: AB90. 31. Haber GB, Marcon NE, Kortan P et al. A 2-year follow up of 25 patients undergoing endoluminal gastric plication (EGLP) for gastroesophageal reflux disease (GERD) (abstract). Gastrointestinal Endoscopy 2001; 53: 116.
Endoscopic suturing 47 32. Shahrier M, Raijman I, Staropoli A et al. Endoluminal gastroplication (EGLP) improves acid-related pulmonary symptoms in GERD patients, Gastrointest Endose 2003; 57: AB100. 33. Filipi CJ & Gerhardt JD. Comparison of endoluminal gastroplication configuration techniques (abstract). American Journal of Gastroenterology 2002; 97: AB89. 34. Thomson MA, Afsal N, DaSouza R et al. Endoscopic gastroplication for the treatment of paediatric gastro-oesophageal reflux disease (abstract). Gut 2003; 52: A70. 35. Swain P, Park P-O & Mills T. Bard EndoCinch: the device, the technique, and pre-clinical studies. Gastrointestinal Endoscopy Clinics of North America 2003; 13: 75– 88. 36. Chuttani R, Kosarek R, Critchlow J et al. A novel endoscopic full-thickness plicator for treatment of GERD: an animal model study. Gastrointestinal Endoscopy 2002; 56: 116–122. 37. Chuttani R. Endoscopic full-thickness plication: the device, technique, pre-clinical and early clinical experience. Gastrointestinal Endoscopy Clinics of North America 2003; 13: 109–116. 38. Rosen M & Ponsky J. Wilson-Cook sewing device: the device, technique, and preclinical studies. Gastrointestinal Endoscopy Clinics of North America 2003; 13: 103 –108. 39. Fritscher Ravens A, Mosse S, Mills T et al. A through-the-scope device for suturing and tissue approximation under endoscopic ultrasound control. Gastrointestinal Endoscopy 2002; 56: 737– 742. 40. Fritscher-Ravens A, Park P & Swain CP. Posterior gastropexy and anterior cruciate ligament suturing under EUS for control of gastro-esophageal reflux. Gut 2002; supplement 111 51, A1.
3 Endoscopic suturing Paul Swain*
MD
Professor Department of Medical Physics, University College London, 11 –20 Capper Street, London WCI, UK
Per-Ola Park
MD
Consultant Surgeon Department of Surgery, Sahlgrenska University Hospital/O¨stra, S-216 85 Gothenburg, Sweden
We describe the development of endoscopic sewing machines and ancillary equipment for knot tying and thread cutting. We outline the experimental studies in dogs, pigs and baboons prior to the first studies in man. We consider the early results achieved by groups in Europe and the U.S.A., and present the available evidence from peer-reviewed studies and data from numerous abstracts on the use of endoscopic suturing in man for treating gastro-oesophageal reflux. We consider the limitations of the available studies, and outline the requirements for improvements in flexible endoscopic suturing methods. Key words: reflux; sewing; suturing; oesophagus; stomach; endoscopy.
Some patients with gastro-oesophageal reflux disease (GORD) have troublesome symptoms which respond poorly to treatment with proton pump inhibitors or other drugs. Others do not want to take medications long term. The medical costs of treating reflux are high and if surgery was effective, safe and inexpensive it might be very cost effective. Long-term acid suppression in any case is not a very logical treatment for GORD, which is not due to excessive acid production but is, in general, due to failure of a valve which normally keeps acid out of the oesophagus. Although laparoscopic or open surgical operations—such as Nissen fundoplication for reflux—seem effective in skilled hands, there are drawbacks to surgery. The complications include impairment of swallowing, diarrhoea, gas bloat, vagotomy, oesophageal perforation, large-vessel bleeding and a small mortality rate. Failures also occur due to wrap disruption, slippage of the wrap and hernia recurrence and poor case selection. There are patients with medical problems and severe reflux in whom the risks of an anaesthetic and pneumo-peritoneum during laparoscopic surgery seem a poor option. Occasional patients are seriously disadvantaged by attempts at reflux surgery. Revision surgery (redo) is associated with a further substantial increase in the chances of morbidity and failure. * Corresponding author. E-mail address: [email protected] (P. Swain). 1521-6918/04/$ - see front matter Q 2003 Elsevier Ltd. All rights reserved.
38 P. Swain and P.-O. Park
A safer, less invasive, effective method for treating reflux using flexible endoscopes passed though the mouth without entering the peritoneal cavity might have advantages for patients who are unsatisfied with medical therapy or who want to stop taking drugs. This presentation outlines the evolution, past, present and possible future of flexible endoscopic treatment using endosurgical sewing techniques for GORD.
THE DEVELOPMENT OF THE ENDOCINCH AND ASSOCIATED DEVICES Devices developed for the Endocinch kit include: sewing machines, tag and thread, devices for tying knots or locking thread, thread-cutting devices and a combination device for attaching the sewing machine body to the endoscope and to assist in loading the threaded tag into the hollow needle. Sewing machines The current Endocinch device is closely based on the fourth flexible endoscopic sewing device to be designed, patented and built by our group in the medical engineering department at University College Hospital and tested in the Royal London Hospital. Our collaborators in this development were Tim Mills and Geoff Brown—a physicist and an engineer, respectively. I would like to acknowledge my great debt to and pleasure working with them over the last 20 years (PS). The first two sewing devices1,2 Our first two sewing devices both used suction into a cavity in order to control the depth and length of the stitch, as in the current Endocinch device, but were designed to place multiple stitches in gastrointestinal tissue. They both used a needle with an eye close to the tip and a swinging catch mechanism and were closer to the design of household sewing machines. The ability to place multiple stitches in tissue quickly and without withdrawing the endoscope remains a highly desirable function to which future endoscopic sewing machine designs will have to return (Table 1). Table 1. U.S.-issued patents related to the EndoCinch endoscopic suturing device. Title Sewing machine Sewing machine Sewing device Device used in securing a thread Device for use in cutting threads Sewing device Control handle for an endoscope Device for use in tying knots Device for use in tying knots
Patent number
Date of issue
4,841,888 5,037,021 5,080,663 5,584,861 5,755,730 5,792,153 5,901,105 6,010,515 6,358,259
Jun 27, 1989 Aug 6, 1991 Jan 14, 1992 Dec 17, 1996 May 26, 1998 Aug 11, 1998 Jun 8, 1999 Jan 4, 2000 Mar 19, 2002
Endoscopic suturing 39
The third sewing device3 The third device we constructed employed a hollow needle with a slot and a rod to force a tag through the needle once it had penetrated tissue, which remains the basic stitch action of the Endocinch. Unlike the later commercially developed device, the needle was pulled rather than pushed, which required a longer rigid head. It was designed to deliver a payload which could be stitched to the deep muscle layer of the stomach. Initially it was used to sew radio-telemetry pH and pressure capsules to the stomach and oesophagus. This sewing device was the first to be used in man. A radiotelemetry pH capsule was sewn into the cardia of a volunteer (PS) and several patients and it transmitted pH data for a period of 5 months before the battery ran out and the capsule was subsequently removed from the stomach once the attachment thread was cut. This third device incorporated several of the features now found in the Endocinch, which was our fourth endoscopic sewing device. A re-design was undertaken to try to improve and simplify the mechanism of sewing. Tag and thread The plastic tag as used in the third machine was changed to a hollow metal tag so that a length of nylon 3.0 thread could be attached to it and used to form the stitch. The tag was improved by making a cut in one end. The tag could be widened to exert a springlike frictional force when it was inside the needle. This mechanism prevented the tag and thread from dropping out prematurely, which had been a problem during the early live experiments. The fourth device which remains the basic design for the Endocinch2 We decided to try to design the smallest, simplest method for placing a full-thickness stitch in human gastric tissue, which could be mounted on a conventional flexible endoscope. We concentrated on designing the sewing suction capsule so that it was as short as possible and also had the smallest cross-sectional area, which would allow the needle to penetrate all the layers of the tissue to place a stitch. The machine was extensively altered following tests in post-mortem human gastric tissue to get these dimensions right. We had excellent links with our pathology department where many post-mortem examinations were being performed. It has recently become much more difficult to get access to human post-mortem tissue for this type of work. Porcine stomach is easier to acquire and keeps well frozen, but the deep muscle is much thicker in a 70 kg animal when compared to a human of the same weight and the mucosa is tougher and less vascular. A stomach from a 20 – 30 kg pig is more similar to an adult human stomach. In order to shorten the rigid length of the sewing machine we decided to try to push rather than pull the needle. The force that can be exerted by pushing a catheter through the biopsy channel of an endoscope is surprisingly low as we found out when we constructed the first flexible endoscopic stapling device.4 It is difficult but possible to push the current 17 gauge needle as used in the Endocinch, mounted on a wire-wound coil catheter, through the stomach wall through an endoscope freehand. We found that if the tissue is constrained by suction within a cavity this splints the tissue to allow penetration by the needle. The mechanical force exerted was improved by using a wire-wound coil, which was strong in compression attached to the needle. A low-friction plastic coating and a smooth fit to reduce lateral forces impinging on
40 P. Swain and P.-O. Park
the wall of the biopsy channel helped. The exit hole dimensions and shape were found by trial and error. If the hole was too large tissue was dragged into the exit hole and increased the force exerted on the needle preventing passage. When the exit hole was made too small, the needle and thread would strike the anvil rather than the hole. We found that we had to prevent needle rotation because the thread could wind around the needle, altering drag and penetration diameter. Initially a pin was used which located in the longitudinal slot of the needle to prevent rotation. A later modification by Bard altered the needle shape from a circular shape into a D configuration and the metal sleeve was similarly altered to prevent needle rotation. The catch mechanism, which now seems an obvious idea, was in fact arrived at by trial and error. At first, we thought that we would push a tag attached to a thread through a full-thickness double layer of tissue and release the tag on the far side. We thought it would then be possible to grab the thread with flexible biopsy or grabbing forceps and pull it back to re-load the thread. We made the end-cap first as a shield to prevent the needle entering tissue again and injecting the tag into submucosal tissue after it had penetrated the desired double layer of tissue. Our first end-caps had a side hole to allow the tag to fall out. When we came to use this in live experiments the tag occasionally became caught in the end-cap and it became apparent that if there were no hole we could pull the thread back to the mouth without having to attempt to grab the tag with forceps. We had to design the machine so that it did not interfere with the visual, washing and inflating function of available endoscopes but allowed us to get good depth of tissue penetration given the eccentrically place position of the biopsy channel through which the needle passed. We elected to take the suction tubing coaxially, external to the endoscope so that we could use the machine with most conventional endoscopes. The tubing was chosen so that it does not collapse if the suction pressure is high and will resist kinking. We studied several different ways of ensuring that the suction pressure was applied in such a way that the cavity in the body was completely filled with tissue. The current design with side holes in a rigid suction tube in the floor of the suction cavity was simple to make and outperformed more complex designs. The length the needle has to pass beyond the tissue before the tag can be reliable ejected, and the length that the pushing rod has to pass beyond the tip of the needle, were also found by trial and error (mostly error). Repeated miss-firings were eventually found to be due to variations of needle and pushing rod length when the endoscope tip was flexed. We were surprised to find that there was a 3 mm difference in emergence of the needle and pushing rod comparing the curved and straight endoscope positions. It was necessary to design the system so that the needle and pushing rod passed further out, which allowed for extra play in this flexible system. The sewing machine body design dimensions and basic mechanism of sewing action have changed little in subsequent modifications of Endocinch. This fourth device was constructed and used in patients before it was taken over and further developed by Bard. Knot tying5 We developed three knotting processes, all of which have been subsequently used in the Endocinch kits. The first we made was a simple cylindrical ring which could be press fitted onto the end of the endoscope. It had two holes on either side through which thread could pass. A half hitch was tied outside the mouth, the threads passed through the two holes and the knot was pushed down to tissue. This was the first to be used in man. It was the second to be used in a modified form in the Endocinch kit. We then made a knot pusher, which was attached to a wire-wound cable so that it could be pushed
Endoscopic suturing 41
backwards and forwards beyond the tip of the endoscope. It had to be back-loaded over a guide-wire up the biopsy channel of an endoscope. It contained a viewing hole, which allowed the knot to be kept in view as a half hitch was pushed down to tissues. This device has tied most of the knots in the earlier human studies. We also developed a collet and sleeve (pin and cylinder method) to lock the thread. Extensive testing with an Instron—which is a device which we used to measure the forces as knots are pulled apart—showed that all of these three knotting methods used at flexible endoscopy could perform as well as hand-tied surgical knots. Recently, Bard have further developed the cylinder-and-pin method way beyond our design; they have made it very small and designed it to cut the thread once the thread has been secured. This is the knotting mechanism incorporated in their current kit. Although it is occasionally a little fiddly to load and to pull the thread through the pin it has the advantage that it is very fast to fire and cut the thread and substantially reduces the number of times the endoscope has to go in and out of the oesophagus. This advance has made it possible to do the whole procedure without using an over-tube. Cutting thread6 Cutting thread was initially accomplished in the first human cases with the use of an Olympus stitch cutter. It was very difficult to cut the thread by simply passing the thread cutter through the biopsy channel because the thread and the cutter lay in the same axis in the oesophagus. We found that if the thread were passed through a gap in the Olympus thread cutter, which was then run down over the thread, it was possible to cut the thread using the thread as its own guide. The cutters had to be passed down to the cardia open and the thread would cut only if placed against the correct blade. We subsequently designed the thread-cutting guillotine, which has been used for most of the human cases. It was only in bench testing using an oesophagus, stomach and over-tube that it became apparent that the guillotine was much faster and more reliable than any other method. A guillotine action has been incorporated into the latest pin and sleeve method for securing thread. A single action cuts the thread and releases the ‘knot’. A guillotine action was included in the current smalldiameter knotting device, which reduced the number of passes required to complete a stitch. A presentation of our work in progress at a British Society of Gastroenterology (BSG) meeting in Dublin in 1993 caught the eye of the BBC news, which had been sent a copy of the programme. The work was little regarded by the BSG, which had awarded it a poster presentation. The BBC programme was shown in most countries of the world and many patients approached us to have the procedure done. With the enthusiastic support of this first cohort of patients who found us we prepared to undertake the first patient studies. Ethical committee approval was sought and granted. Several patients had already been treated before Bard agreed to take on the device and develop what later became the EndoCinch. Per-Ola Park, who is a surgeon in Sweden, became interested and visited London and invited Paul Swain to Va¨xjo¨ on several occasions to assist with the procedures. Per-Ola Park uses two video systems so that the two endoscopes used for the procedure do not have to be unplugged and then plugged into the same videoprocessor and trained his assistants to have the knot-tying device loaded while the endoscopist is placing the stitches. We have both changed from an improvized method with gathering tags for re-use and tying thread to using the kits provided (but hoarding sterile spare threads and knot-tying components for use in experiments or to place extra stitches in patients if necessary).
42 P. Swain and P.-O. Park
The Endocinch device has been used mainly to treat GORD.7 It has also been used to close oesophageal and gastric perforations and attach pH radio-telemetry capsules to the oesophagus, stomach and duodenum and attach feeding tubes to the stomach wall. Endoscopic gastroplasty is a minimally invasive surgical procedure for gastrooesophageal reflux, which has been performed at flexible endoscopy without laparotomy or laparoscopy.7 This operation is similar to a Collis’ gastroplasty, which was initially developed as a method for treating ‘short oesophagus’ which may be a synonym for, or equivalent to, a Barrett’s oesophagus.8 Other reflux procedures performed using the Endocinch We examined a reflux procedure, which more closely resembled a Nissen fundoplication.7 The operation involved stitching through the oesophagus to form the wrap and required more stitches. We elected to start in humans with the simplest, safest and quickest operation which gave good results in the animal studies. It seems feasible to achieve a closer approximation to a Nissen-like wrap endoluminally but the tools are not yet available to do this. Variant gastroplasty techniques have been described using the Endocinch device. Filipi randomized a circumferential stitch configuration to a longitudinal in a multi-centre American study. There were no significant differences between these configurations. Others, especially Raijman and Chen, have developed a helical technique. More information is needed from comparative methods to optimize the stitch position and numbers of stitches. Conical valve prosthesis attachment9 A light tubular prosthetic valve formed in the shape of a conical tube was developed in Switzerland. This has been sewn to the cardio-oesophageal junction and shown to produce an increase in lower oesophageal sphincter length of 7 cm (the length of the valve) in pigs. It did not alter the lower oesophageal sphincter pressure. This device has been tested in a few patients with reflux. Clinical results with endoscopic gastroplasty Promising results have been reported in both European10 and American11 series using endoscopic sewing machine technology. The results of endoscopic gastroplasty suggest that this operation can improve reflux symptoms and measured acid exposure of distal oesophagus and increase lower oesophageal sphincter length and pressure. These results were observed in 142 patients with GORD.12 Symptoms assessed by DeMeester score improved from a median of 5 to 1 (P , 0:05). Median lower oesophageal sphincter length increased from 2 to 3 cm (P , 0:05) and pressure increased from 5 to 8 mmHg (P , 0:05). Median % time pH , 4 decreased from 8.4 to 2.7 (P , 0:05). Good symptomatic results were obtained with endoscopic gastroplasty in 64 patients in a multi-centre American study.11 Half the patients had stitches placed below the cardio-oesophageal junction in a linear configuration and the other half in a circumferential configuration. Patients with hiatus hernia . 2 cm and with Barrett’s oesophagus were excluded from this study. Sixty-two percent of patients experienced success at 3 months. Heartburn scores improved from 62.5 to 16.6, heartburn severity improved from 22.8 to 9.2 and regurgitation from 1.8 to 0.6. All of these end-points
Endoscopic suturing 43
were highly significant (P , 0:0001). Patients with acid exposure , 10% had a significant improvement in % time pH , 4, P , 0:002: Complications were relatively uncommon and included bleeding, over-sedation and a single perforation. Dysphagia appeared less common than with Nissen fundoplication. The procedure does not prevent or make subsequent surgery more difficult. Most patients went home within a few hours of the procedure and were able to work the day after the procedure. There are now a number of studies which assess and, in general, support the value of endoluminal suturing as a means of treating reflux. Rothstein’s excellent recently published monograph13 in Gastrointestinal Endoscopy Clinics of North America reviews most of the flexible endoscopic methods and gives a good account of the reported trials using the Endocinch device.14 He concludes ‘the BARD EndoCinch procedure seems safe and demonstrated an acceptable efficacy for symptom control during short-term follow-up’. Fennerty has contributed a cool and cautious review of the current available evidence15 in Gastrointestinal Endoscopy. He suggested that, at this time, only an indeterminate recommendation for EST (endoscopic suturing therapy) as a treatment for GORD can be given. He concluded by suggesting that possible future indications for EST might be: (1) as primary therapy for GORD in patients desiring nonpharmacological or surgical therapy, (2) as an adjunctive or salvage therapy for GORD to (a) decrease medication requirements or (b) improve medical or surgical response. It is quite hard to summarize the results achieved to date by reviewing the several studies mostly in abstract form.11,16 – 33 Only two peer-reviewed studies have been published in full to date.11,21 Most studies appear to show substantial symptomatic improvement and significant reduction in the use of proton pump inhibitor medications. For example, 10/10 studies published in abstract form reported statistically significant improvement in heartburn symptom scores in a follow-up of 3 –12 months.11,16 – 18,20 – 24,29 Seven of seven studies reported significant improvement in regurgitation frequency scores. All studies reported a reduction in medication use; 20 –76% were completely off proton pump inhibitor (PPI) treatment at 3 –12 months. Nine of ten studies showed a significant reduction in oesophageal 24-hour pH exposure: refs 11,16 –18,20,21,23,24,29/ref. 22. Four of eight studies showed a significant effect on lower oesophageal sphincter pressure and/or length: refs 16,17,27, 29/refs 11,20 – 22. One study showed that transient lower oesophageal sphincter relaxations are reduced by endoscopic gastroplasty.27 Some groups have examined cost effectiveness. Chen et al18, for example, reported that 183 patients studied 12 months post-endoluminal gastroplication reported significant improvements in heartburn and regurgitation, while noting substantial costsavings due to the elimination or reduction of GORD prescriptives, especially PPIs (P . 0:0001). Pre-ELGP annual drug costs of $2379 compared to $351 at 12 months following ELGP (P , 0:0001)—an average annual drug cost-savings of $2028. Annualized medication costs in a study by Raijman et al were $2836 before ELGP, $327 after EGLP.19 There is of course a paucity of data on longer-term outcomes. Significant improvement in heartburn severity and frequency scores were reported in two studies. About 25% were completely off PPI therapy and another third to a half were taking less than half their original dose.28,31 The first 14 patients treated for GORD in Va¨xjo¨ have been followed for 4 years. Four out of the 14 patients were failures and have later been operated with NissenRosetti fundoplication wihtout any complications. Seven of the remaining patients have
44 P. Swain and P.-O. Park
been followed-up with 24-hour pH monitoring and interviews. The median preoperative Demeester score was 7 and after 4 years it was 3. The patients were taking PPIs daily before the gastroplasty and after the 4 years four patients were still off PPIs and the other three patients needed PPIs only two or three times a week. The median 24-hour pH value was 6.8% prior to the gastroplasty and was 5.2% at 4 years after the procedure. An Irish study has shown that the clinical results in reducing heartburn are almost as good as those achieved by Nissen fundoplication but with a lower complication rate and cost.30 Some studies have examined variation in pattern and number of stitches. Filipi and colleagues compared a linear with a circumferential stitch configuration.11,33 There were no significant differences but the linear configuration was a little ahead. In our own experiments in pigs (25 kg), there was a twofold and significant increase in yield pressure after one plication. After two plications the yield pressure increased 2.5 times compared with controls (no sutures). We were not able to show any difference between circumferential and linear configurations. Raijman et al have popularized a helical configuration.17 Lehman and colleagues have suggested that the addition of cautery may enhance stitch survival.25 Our group suggested avoiding patients with hiatus hernias larger than 2 cm in size because our results were less good; with these patients this exclusion criterion has been included in most subsequent trials of endotherapy for GORD.11 Raijman et al have suggested that good results can be obtained in patients with large hernias but that more stitches may be required.19 One series has suggested that patients with reflux-related pulmonary complications can be improved by this procedure.32 A study from the U.K. has shown that endoscopic suturing with the Bard device can produce good results in children with reflux and can normalize pH values in most patients.34 There is, of course, room for improvement. More work is needed to make endoscopic suturing easier, quicker and more reliable. In our view the single most important next goal is to construct a device which can place multiple stitches without the need to remove the endoscope between each stitch. Devices which can place two stitches in one go would be a start. We have reported the development of double stitch as well as multiple-stitch devices.35 We were pleased to see two alternative commercial endoscopic sewing devices appear at the last DDW, one from NDO36,37 and the other from Wilson Cook38, which place two but not more stitches without needing to withdraw the endoscopes—both use a double-needle method. All the above anti-reflux devices are limited in that they can apply stitches only to the gastric cardia or oesophagus but cannot vary or view the depth of stitch placement; neither can they return the lower oesophageal sphincter to a subdiaphragmatic position if the sphincter has migrated upwards. They cannot repair a hiatus hernia if present and they do not attach the stomach to other abdominal structures. Experimental studies in pigs using endoscopic ultrasound and modified needles have allowed suturing at flexible endoscopy.39 Two procedures have been studied.40 The first is a posterior gastropexy, which is the basis of a Hill repair in which stitches are placed though the wall of the stomach into the median arcuate ligament. The second involves placing stitches into the right crura in order to ‘reduce’ a hiatus hernia. These studies at least suggest that endoscopic suturing could undergo substantial further development in different directions before a standard technique emerges.
Endoscopic suturing 45
CONCLUSION Most reviews on this and other topics tend to close by suggesting that more studies are needed; that randomized studies and sham studies should be performed and that more long-term follow-up data would help. Although such conclusions are valid, they miss the point that these suturing techniques are in their infancy. It is important, of course, that some studies at this stage should show that reasonably promising results have been obtained with existing equipment. There is currently a much greater need for better engineering solutions than for better clinical studies. Improvements are needed as follows. Stitches should be placed to a predetermined depth, probably in the muscularis propria or perhaps through to the serosa. Multiple stitches need to be placed with the knot tied without having to withdraw the endoscope and re-load thread, tie knots or add fixation devices. The device should preferably determine the gap between the stitches as well as the tension on the tissue. It is thinkable to develop a flexible endoscopic method which could use sutures to treat reflux in a standardized procedure requiring minimal skill and take less than 5 minutes to complete. Practice points † † † † † † † † †
mechanisms of sewing machine action for use at flexible endoscopy evolution of sewing machines development and mechanism of action of three knotting methods development of cutting methods with scissors and guillotines experimental studies and types of endoluminal flexible endoscopic anti-reflux operations early clinical studies review of recent studies and clinical outcomes new suturing methods transluminal endoscopic ultrasound surgery for reflux
Research agenda † † † †
new-action sewing machines faster sewing machines multiple-stitch sewing machines suturing at endoscopic ultrasound (posterior gastropexy and hiatus hernia repair) † need for better understanding of the physiology of reflux † need for better clinical data with randomized or sham studies † main need is for more engineering input to simplify the procedure
REFERENCES * 1. Swain CP & Mills TN. An Endoscopic sewing machine. Gastrointestinal Endoscopy 1986; 32: 36–37. * 2. Swain CP. Endoscopic sewing and stapling machines. Endoscopy 1997; 29: 205–210. * 3. Swain CP, Brown G, Gong F & Mills TN. An endoscopically deliverable tissue transfixing device for securing biosensors in the gastrointestinal tract. Gastrointestinal Endoscopy 1994; 40: 730–734.
46 P. Swain and P.-O. Park * 4. Swain CP, Brown G & Mills TN. An endoscopic stapling device: development of a new flexible endoscopically controlled device for placing multiple transmural staples in gastrointestinal tissue. Gastrointestinal Endoscopy 1989; 35: 338–339. * 5. Swain CP, Kadirkamanathan SS, Gong F et al. Knot tying at flexible endoscopy. Gastrointestinal Endoscopy 1994; 40: 722 –729. * 6. Gong F, Swain P, Kadirkamanathan S et al. Cutting thread at flexible endoscopy. Gastrointestinal Endoscopy 1996; 44: 667 –674. * 7. Kadirkamanathan SS, Evans DF, Gong F et al. Antireflux operations at flexible endoscopy using endoluminal stitching techniques: an experimental study. Gastrointestinal Endoscopy 1996; 44: 133–143. 8. Collis JL. An operation for hiatus hernia with short esophagus. Journal of Thoracic Surgery 1957; 34: 768–778. 9. Godin NJ, Swain CP, Gong F et al. Endoscopic suturing of a novel gastro-esophageal antireflux device (GARD): a preliminary report. Gastrointestinal Endoscopy 1996; 43: 336. 10. Swain CP, Park PO, Kjellin T et al. Endoscopic gastroplasty for gastro-esophageal reflux disease. Gastrointestinal Endoscopy 2000; 51: AB144. (abstract). 11. Filipi CJ, Edmundowicz SA, Gostout CJ et al. Transoral endoscopic suturing for gastro-esophageal reflux disease: a multicenter trial. Gastrointestinal Endoscopy 2000; 51: AB143. (abstract). * 12. Filipi CJ, Lehman GA, Rothstein RI et al. Transoral, flexible endoscopic suturing for treatment of GERD: a multicenter trial. Gastrointestinal Endoscopy 2001; 53: 416–422. 13. Rothstein RI. Endoscopic therapy for gastroesophageal reflux disease. Gastrointestinal Endoscopy Clinics of North America 2003; 13: 1–226. * 14. Rothstein RI & Filipi CJ. Endoscopic suturing for gastroesophageal: clinical outcome with the Bard EndoCinch. Gastrointestinal Endoscopy Clinics of North America 2003; 13: 89–101. * 15. Fennerty MB. Endoscopic suturing for treatment of GERD. Gastrointestinal Endoscopy 2003; 57: 390–395. 16. Swain CP, Kadirkamanathan SS, Gong F et al. Endoscopic gastroplasty for gastroesophageal disease (abstract). Gastrointestinal Endoscopy 1997; 47: AB85. 17. Raijman I, Ben-Menachem T, Reddy G et al. Symptomatic response to endoluminal gastroplication (ELGP) in patients with gastroesophageal reflux disease: a multi-center study. Gastrointestinal Endoscopy 2001; 53: AB74. abstract 738. 18. Chen YK, Raijman I, Ben-Menachem T et al. One-year follow-up of endoluminal gastroplication: clinical and economic outcomes of the U.S. multicenter trial. Gastrointestinal Endoscopy 2002; 55. abstract M1887. 19. Raijman I, Ben-Menachem T, Starpoli AA et al. Endoluminal gastroplication improves GERD symptoms in patients with large hiatal hernia. Gastrointestinal Endoscopy 2002; 55. abstract AB 255. 20. Caca K, Schiefke J, Soder H et al. Endoluminal gastroplicaiton (Endocinch) in GERD patients refractory to PPI therapy. Gastrointestinal Endoscopy 2002; 55. abstract AB257. 21. Mahmood Z, McMahon BP, Arfin Q et al. Endocinch therapy for gastro-oesophageal reflux disease: a one year prospective follow up. Gut 2003; 52: 34–39. 22. Lui J, Knapp R & Carr-Lock D. Treatment of medication refractory gastroesophageal reflux disease with endoluminal gastroplication. Gastrointestinal Endoscopy 2002; 55. abstract AB252. 23. Abdu-Rebyeh H, Hoepffner N, Osmanoglou E et al. Endoscopic suturing is able to reduce pathological acid reflux in gastroesophageal disease. Gastrointestinal Endoscopy 2002; 55. abstract 259. 24. Arts J, Sloomaekers S, Sifrim D et al. Endoluminal gastroplication (Endocinch) in GERD patients refractory to PPI therapy (abstract). Gastroenterology 2002; 122: AB391. 25. Lehman GA, Dunne DP, Heiston K et al. Suturing plication of cardia with Endocinch device: effect of supplementary cautery. A human prospective trial (abstract). Gastrointestinal Endoscopy 2002; 55: AB260. 26. Raijman I, Ben-Menachem T, Reddy G & Chen Y. Symptomatic response to endoluminal gastroplication (EGLP) in patients with gastroesophageal reflux disease: a multi-center study (abstract). Gastrointestinal Endoscopy 2001; 53: 74. 27. Tam W, Holloway R, Dent J et al. Impact of endoscopic suturing of the gastroesophageal junction on lower esophageal sphincter function and gastroesophageal reflux in patients with reflux disease (abstract). Gastroenterology 2002; 122: AB390. 28. Rothstein RI, Pohl H, Grove M et al. Endoscopic gastric plication for the treatment of GERD: two year follow-up results (abstract). American Journal of Gastroenterology 2001; 96S: 107. 29. Swain CP, Park PO, Kjellin T et al. Endoscopic gastroplasty for gastro-oesophageal reflux disease (abstract). Gastrointestinal Endoscopy 2001; 51: 144. 30. Mahmood Z, Byrne PJ, McCullough J et al. A comparison of Bard Endocinch transesophageal endoscopic plication (BETEP) with laparoscopic Nissen fundoplication (LNF) for the treatment of gasto-esophageal reflux disease (abstract). Gastrointestinal Endoscopy 2002; 55: AB90. 31. Haber GB, Marcon NE, Kortan P et al. A 2-year follow up of 25 patients undergoing endoluminal gastric plication (EGLP) for gastroesophageal reflux disease (GERD) (abstract). Gastrointestinal Endoscopy 2001; 53: 116.
Endoscopic suturing 47 32. Shahrier M, Raijman I, Staropoli A et al. Endoluminal gastroplication (EGLP) improves acid-related pulmonary symptoms in GERD patients, Gastrointest Endose 2003; 57: AB100. 33. Filipi CJ & Gerhardt JD. Comparison of endoluminal gastroplication configuration techniques (abstract). American Journal of Gastroenterology 2002; 97: AB89. 34. Thomson MA, Afsal N, DaSouza R et al. Endoscopic gastroplication for the treatment of paediatric gastro-oesophageal reflux disease (abstract). Gut 2003; 52: A70. 35. Swain P, Park P-O & Mills T. Bard EndoCinch: the device, the technique, and pre-clinical studies. Gastrointestinal Endoscopy Clinics of North America 2003; 13: 75– 88. 36. Chuttani R, Kosarek R, Critchlow J et al. A novel endoscopic full-thickness plicator for treatment of GERD: an animal model study. Gastrointestinal Endoscopy 2002; 56: 116–122. 37. Chuttani R. Endoscopic full-thickness plication: the device, technique, pre-clinical and early clinical experience. Gastrointestinal Endoscopy Clinics of North America 2003; 13: 109–116. 38. Rosen M & Ponsky J. Wilson-Cook sewing device: the device, technique, and preclinical studies. Gastrointestinal Endoscopy Clinics of North America 2003; 13: 103 –108. 39. Fritscher Ravens A, Mosse S, Mills T et al. A through-the-scope device for suturing and tissue approximation under endoscopic ultrasound control. Gastrointestinal Endoscopy 2002; 56: 737– 742. 40. Fritscher-Ravens A, Park P & Swain CP. Posterior gastropexy and anterior cruciate ligament suturing under EUS for control of gastro-esophageal reflux. Gut 2002; supplement 111 51, A1.