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Submucosal Endoscopic Esophageal Myotomy: A Novel Experimental Approach for the Treatment of Achalasia
Abstracts
341 The Use of Waterjet Technology in Gastrointestinal Endoscopy: An Experimental Study of Two New Techniques for Endoscopic Submucosal Dissection Vincent Lepilliez, Carlos Robles-Medranda, Hannah Lukashok, Marwan Chemaly, Stephan Langonnet, Sabrina Chesnais, Florence Arnal, Valerie Hervieu, Thierry Ponchon Background: Endoscopic submucosal dissection (ESD) allows one-piece resection of superficial neoplastic digestive lesions. However ESD is a difficult and timeconsuming procedure with a significant morbidity rate. Water jet technology (WJ) is a new surgical tool under investigation in many medical areas. It has demonstrated a clear technical advantage over the conventional methods of dissection. The objective of our study is to demonstrate the possible applications of WJ in GI endoscopy especially in ESD and to evaluate 2 new techniques of ESD using WJ comparing to the conventional technique. Materials and Methods: 12 domestic pigs were used for this study. 3 techniques A, B & C were compared for gastric and esophageal ESD. Technique A (standard): saline solution was injected manually into the submucosal layer and ESD was performed with the IT-knife. Technique B (partial WJ): saline solution was injected with the WJ system (catheter inner diameter 0.2 mm, 10-20 bars, 82-120 ml/min) and ESD was conducted with the IT-knife. Technique C (total WJ): saline solution was injected with the WJ system and ESD was done with the WJ unit using a catheter prototype specially developed. The diameter of gastric resections ranged from 5 to 10 cm, and the length of circumferential esophageal resections ranged from 5 to 10 cm. The evaluation data were: 1) Dissection duration per cm2 dissected 2) Dissection feasibility and easiness estimated on an analogical visual scale (AVS) for the peripheral incision and the submucosal dissection phases 3) Morbidity: bleeding and perforations. Results: A total of 48 pieces (16/technique) were obtained (36 from stomach and 12 from esophagus). In stomach, technique B (combined IT-WJ) was the fastest technique, with an average time of 1.03 cm2/min vs 0.7 and 0.52 cm2/min with technique A & C respectively (p ! 0.05). Moreover, technique B was the easiest technique to learn and to perform, in accordance to the AVSs, and resulted in the smallest morbidity rates: two times less immediate bleeding than IT-C-ESD (p ! 0.05). In esophagus, technique C (total WJ) was the fastest technique with an average time of 1.35 cm2/ min vs 0.42 and 1.02 cm2/min with technique A & B respectively, being also the easiest technique to learn and to perform, in accordance to the AVSs. Technique C presented the smallest rate of immediate bleeding (NS). 1 perforation was observed with technique A. Conclusions: These results confirm the potential role of WJ to permit easier, faster and safer ESD. WJ is not only effective to facilitate dissection such as in the esophagus but also to produce a very homogeneous diffuse and longlasting water cushion such as in the stomach.
342 The New Approach for the Difficult Cases in Early Gastric Cancer Treatment- Development of Double Scope-ESD Method Yoshinori Morita, Masanori Toyoda, Yuko Matsumoto, Masaru Yoshida, Takao Tamura, Hiromu Kutsumi, Hideto Inokuchi, Takeshi Azuma Introduction: Endoscopic submucosal dissection (ESD) has enabled en-bloc resection for early gastric cancer (EGC) regardless of tumor size and ulcer findings. However, in case of quite a large lesion, difficult location such as greater curvature of corpus, and lesions with severe fibrosis, it is difficult to accomplish by conventional ESD methods. Aims & Methods: In order to overcome these difficult cases in ESD, we developed double scope ESD (D-ESD) using flexible large doublelumen overtube. This study introduced our preliminary experience and evaluated the feasibility, efficacy and procedure time. Ten consecutive patients with differentiated mucosal EGC judged by biopsy and EUS were enrolled, whose lesions have some difficulties that cannot be conquered with conventional ESD due to the followings reasons: 1. Quite a large lesion (more than 50 mm), 2. Difficult location (more than 30 mm lesion at the greater curvature of corpus), 3. With severe fibrosis (due to ulcer scar). D-ESD was performed by two kinds of endoscope. One is a N260(Olympus) with small diameter, which assists in holding clear view by catching and lifting the targeted lesion. The other is a Q260J(Olympus) having the function of water-jet, which enables easy detection of oozing point. VIO300D (ERBE) was used for an electrical surgical unit. Mucosal cutting and dissection was performed by insulation-tipped knife (IT knife, Olympus). Results: The mean procedure time was 58 min. All the patients achieved complete resection without massive bleeding or perforation. Injuries of the hypopharynx and the esophagus by the overtube were not observed. IT knife could be moved in the parallel line to submucosal layer. Vessels in submucosal layer were easily detected, and severe bleeding could be avoided by pre-coagulation. Water-jet enabled to detect the just point of minor bleeding in a clear view. All the lesions were tolerable for the histopathological evaluation, which were well-differentiated tubular adenocarcinomas within mucosal invasion without vessel invasion. Conclusion: DESD can provide a good feasibility and efficacy even in the difficult cases of EGC, which can expand the indication to lesions that are considered impossible to treat by conventional ESD.
AB92 GASTROINTESTINAL ENDOSCOPY Volume 65, No. 5 : 2007
343 Submucosal Endoscopic Esophageal Myotomy: A Novel Experimental Approach for the Treatment of Achalasia Pankaj J. Pasricha, Rami Hawari, Ijaz Ahmed, Peter B. Cotton, Christopher J. Gostout, Robert H. Hawes, Anthony N. Kalloo, Sergey V. Kantsevoy, Douglas L. Brining Introduction: The single most permanent method of treating achalasia is a surgical myotomy. Because of the requirement for a mucosal incision and the risk of perforation, this procedure has not been generally approached endoscopically. We hypothesized that we could perform a safe and robust myotomy using the SEMF method (submucosal endoscopy with mucosal flap). Methods: 4 young pigs were used for this study. Baseline LES pressures were recorded and then the pigs underwent upper endoscopy using a standard endoscope. Approximately 5 cm above the LES, a submucosal saline lift was created and a small nick made in the mucosa to facilitate the introduction of a 12 mm dilating balloon. After dilation, the scope was introduced over the balloon into the submucosal space and advanced towards the now visible fibers of the LES. Subsequently, using an electrocautery knife the circular layer of muscle was cleanly incised in a distal-to-proximal fashion without complications. The scope was then withdrawn back into the lumen and the mucosal defect closed with endoscopically applied clips. The entire procedure generally took less than 15 minutes. Results: The procedure was successful in all pigs. The first pig was sacrificed immediately due to respiratory distress from an unrelated cause. The other three pigs were observed for a week and appeared to do well without evidence of fever or loss of appetite. Manometry and subsequent sacrifice were performed after 5-7 days. LES pressures fell significantly to 37.2 þ 16% of baseline (p Z 0.03). Necropsy revealed no evidence of mediastinitis and the outermost esophageal wall layer was intact in all. Conclusions: Endoscopic submucosal esophageal myotomy is feasible, safe and effective in the short-term. It has the potential for being useful in patients with achalasia. The submucosal space is a novel and important field of operation for endoscopic procedures.
344 Early Clinical Experience with a New Simple Flexible Endoscopic Suturing Method for Intra-Luminal and Transgastric Surgery (NOTES) Per-Ola Park, Maria Bergstrom, Annette Fritscher-Ravens, Keiichi Ikeda, Sandy Mosse, Paul Swain Background: In order to perform advanced endoscopic treatments, like dealing with perforations, full-thickness resections one has to be able to close defects. There have been many devices constructed to perform endoscopic suturing, but all are rather complicated, expensive and difficult to use. Method 17 and 19G flexible needles constrained within a plastic catheter loaded with a metal tag, to which a 3-0 polypropylene thread was attached, were passed down the working-channel of a conventional endoscope. Two tags are placed into the wall of the stomach wall, one on each side of the defect. The threads are then locked together using a ring and pin (collet and sleeve method). The thread is cut using a guillotine. Precise stitch positioning is easily performed in the middle of the visual field. Multiple stitches can be placed quickly without the need to remove the endoscope during the procedure. An overtube is unnecessary and the device can be used with 9 mm flexible endoscopes with a 2.8 mm channel. The component of this device all are CE marked. Ethical committee approval was received for the use of this method to oversew perforated ulcers in Gothenburg. Results: By using this simple technique we were able to close perforations, perform gastro-jejunostomies and pyloplasty in experimental porcine models in survival animals. We have also been able to close perforated duodenal ulcer, leaking anastomosis and stop upper GI-bleeding successfully in patients when other methods of treatment had failed. Conclusions: The above described technique is simple, easy to use and makes endoscopic suturing possible almost anywhere in the GI-tract which can be reached by a flexible endoscope. The suturing technique makes it possible to close perforations and approximate tissue without laparoscopic or open surgery. The first clinical results reported in three patients.
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341 The Use of Waterjet Technology in Gastrointestinal Endoscopy: An Experimental Study of Two New Techniques for Endoscopic Submucosal Dissection Vincent Lepilliez, Carlos Robles-Medranda, Hannah Lukashok, Marwan Chemaly, Stephan Langonnet, Sabrina Chesnais, Florence Arnal, Valerie Hervieu, Thierry Ponchon Background: Endoscopic submucosal dissection (ESD) allows one-piece resection of superficial neoplastic digestive lesions. However ESD is a difficult and timeconsuming procedure with a significant morbidity rate. Water jet technology (WJ) is a new surgical tool under investigation in many medical areas. It has demonstrated a clear technical advantage over the conventional methods of dissection. The objective of our study is to demonstrate the possible applications of WJ in GI endoscopy especially in ESD and to evaluate 2 new techniques of ESD using WJ comparing to the conventional technique. Materials and Methods: 12 domestic pigs were used for this study. 3 techniques A, B & C were compared for gastric and esophageal ESD. Technique A (standard): saline solution was injected manually into the submucosal layer and ESD was performed with the IT-knife. Technique B (partial WJ): saline solution was injected with the WJ system (catheter inner diameter 0.2 mm, 10-20 bars, 82-120 ml/min) and ESD was conducted with the IT-knife. Technique C (total WJ): saline solution was injected with the WJ system and ESD was done with the WJ unit using a catheter prototype specially developed. The diameter of gastric resections ranged from 5 to 10 cm, and the length of circumferential esophageal resections ranged from 5 to 10 cm. The evaluation data were: 1) Dissection duration per cm2 dissected 2) Dissection feasibility and easiness estimated on an analogical visual scale (AVS) for the peripheral incision and the submucosal dissection phases 3) Morbidity: bleeding and perforations. Results: A total of 48 pieces (16/technique) were obtained (36 from stomach and 12 from esophagus). In stomach, technique B (combined IT-WJ) was the fastest technique, with an average time of 1.03 cm2/min vs 0.7 and 0.52 cm2/min with technique A & C respectively (p ! 0.05). Moreover, technique B was the easiest technique to learn and to perform, in accordance to the AVSs, and resulted in the smallest morbidity rates: two times less immediate bleeding than IT-C-ESD (p ! 0.05). In esophagus, technique C (total WJ) was the fastest technique with an average time of 1.35 cm2/ min vs 0.42 and 1.02 cm2/min with technique A & B respectively, being also the easiest technique to learn and to perform, in accordance to the AVSs. Technique C presented the smallest rate of immediate bleeding (NS). 1 perforation was observed with technique A. Conclusions: These results confirm the potential role of WJ to permit easier, faster and safer ESD. WJ is not only effective to facilitate dissection such as in the esophagus but also to produce a very homogeneous diffuse and longlasting water cushion such as in the stomach.
342 The New Approach for the Difficult Cases in Early Gastric Cancer Treatment- Development of Double Scope-ESD Method Yoshinori Morita, Masanori Toyoda, Yuko Matsumoto, Masaru Yoshida, Takao Tamura, Hiromu Kutsumi, Hideto Inokuchi, Takeshi Azuma Introduction: Endoscopic submucosal dissection (ESD) has enabled en-bloc resection for early gastric cancer (EGC) regardless of tumor size and ulcer findings. However, in case of quite a large lesion, difficult location such as greater curvature of corpus, and lesions with severe fibrosis, it is difficult to accomplish by conventional ESD methods. Aims & Methods: In order to overcome these difficult cases in ESD, we developed double scope ESD (D-ESD) using flexible large doublelumen overtube. This study introduced our preliminary experience and evaluated the feasibility, efficacy and procedure time. Ten consecutive patients with differentiated mucosal EGC judged by biopsy and EUS were enrolled, whose lesions have some difficulties that cannot be conquered with conventional ESD due to the followings reasons: 1. Quite a large lesion (more than 50 mm), 2. Difficult location (more than 30 mm lesion at the greater curvature of corpus), 3. With severe fibrosis (due to ulcer scar). D-ESD was performed by two kinds of endoscope. One is a N260(Olympus) with small diameter, which assists in holding clear view by catching and lifting the targeted lesion. The other is a Q260J(Olympus) having the function of water-jet, which enables easy detection of oozing point. VIO300D (ERBE) was used for an electrical surgical unit. Mucosal cutting and dissection was performed by insulation-tipped knife (IT knife, Olympus). Results: The mean procedure time was 58 min. All the patients achieved complete resection without massive bleeding or perforation. Injuries of the hypopharynx and the esophagus by the overtube were not observed. IT knife could be moved in the parallel line to submucosal layer. Vessels in submucosal layer were easily detected, and severe bleeding could be avoided by pre-coagulation. Water-jet enabled to detect the just point of minor bleeding in a clear view. All the lesions were tolerable for the histopathological evaluation, which were well-differentiated tubular adenocarcinomas within mucosal invasion without vessel invasion. Conclusion: DESD can provide a good feasibility and efficacy even in the difficult cases of EGC, which can expand the indication to lesions that are considered impossible to treat by conventional ESD.
AB92 GASTROINTESTINAL ENDOSCOPY Volume 65, No. 5 : 2007
343 Submucosal Endoscopic Esophageal Myotomy: A Novel Experimental Approach for the Treatment of Achalasia Pankaj J. Pasricha, Rami Hawari, Ijaz Ahmed, Peter B. Cotton, Christopher J. Gostout, Robert H. Hawes, Anthony N. Kalloo, Sergey V. Kantsevoy, Douglas L. Brining Introduction: The single most permanent method of treating achalasia is a surgical myotomy. Because of the requirement for a mucosal incision and the risk of perforation, this procedure has not been generally approached endoscopically. We hypothesized that we could perform a safe and robust myotomy using the SEMF method (submucosal endoscopy with mucosal flap). Methods: 4 young pigs were used for this study. Baseline LES pressures were recorded and then the pigs underwent upper endoscopy using a standard endoscope. Approximately 5 cm above the LES, a submucosal saline lift was created and a small nick made in the mucosa to facilitate the introduction of a 12 mm dilating balloon. After dilation, the scope was introduced over the balloon into the submucosal space and advanced towards the now visible fibers of the LES. Subsequently, using an electrocautery knife the circular layer of muscle was cleanly incised in a distal-to-proximal fashion without complications. The scope was then withdrawn back into the lumen and the mucosal defect closed with endoscopically applied clips. The entire procedure generally took less than 15 minutes. Results: The procedure was successful in all pigs. The first pig was sacrificed immediately due to respiratory distress from an unrelated cause. The other three pigs were observed for a week and appeared to do well without evidence of fever or loss of appetite. Manometry and subsequent sacrifice were performed after 5-7 days. LES pressures fell significantly to 37.2 þ 16% of baseline (p Z 0.03). Necropsy revealed no evidence of mediastinitis and the outermost esophageal wall layer was intact in all. Conclusions: Endoscopic submucosal esophageal myotomy is feasible, safe and effective in the short-term. It has the potential for being useful in patients with achalasia. The submucosal space is a novel and important field of operation for endoscopic procedures.
344 Early Clinical Experience with a New Simple Flexible Endoscopic Suturing Method for Intra-Luminal and Transgastric Surgery (NOTES) Per-Ola Park, Maria Bergstrom, Annette Fritscher-Ravens, Keiichi Ikeda, Sandy Mosse, Paul Swain Background: In order to perform advanced endoscopic treatments, like dealing with perforations, full-thickness resections one has to be able to close defects. There have been many devices constructed to perform endoscopic suturing, but all are rather complicated, expensive and difficult to use. Method 17 and 19G flexible needles constrained within a plastic catheter loaded with a metal tag, to which a 3-0 polypropylene thread was attached, were passed down the working-channel of a conventional endoscope. Two tags are placed into the wall of the stomach wall, one on each side of the defect. The threads are then locked together using a ring and pin (collet and sleeve method). The thread is cut using a guillotine. Precise stitch positioning is easily performed in the middle of the visual field. Multiple stitches can be placed quickly without the need to remove the endoscope during the procedure. An overtube is unnecessary and the device can be used with 9 mm flexible endoscopes with a 2.8 mm channel. The component of this device all are CE marked. Ethical committee approval was received for the use of this method to oversew perforated ulcers in Gothenburg. Results: By using this simple technique we were able to close perforations, perform gastro-jejunostomies and pyloplasty in experimental porcine models in survival animals. We have also been able to close perforated duodenal ulcer, leaking anastomosis and stop upper GI-bleeding successfully in patients when other methods of treatment had failed. Conclusions: The above described technique is simple, easy to use and makes endoscopic suturing possible almost anywhere in the GI-tract which can be reached by a flexible endoscope. The suturing technique makes it possible to close perforations and approximate tissue without laparoscopic or open surgery. The first clinical results reported in three patients.
www.giejournal.org