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Closure of Gastric Perforation with a Novel Tissue Anchoring Device
Abstracts
720 Measurements of Intraperitoneal Pressure During Flexible Transgastric Surgery and the Development of a Feed-Back Control Valve for Regulating Pressure Per-Ola Park, Maria Bergstrom, Paul Swain
722 Initial Experience with a Novel Endoscopic Device Allowing Intragastric Manipulation and Plication John D. Mellinger, Bruce V. Macfadyen, Richard A. Kozarek, Nathaniel D. Soper, Desmond H. Birkett, Lee L. Swanstrom
Background: Transgastric surgical techniques using flexible endoscopes have been introduced without monitoring intra-peritoneal pressure or feedback control of inflation, which are standard during conventional rigid laparoscopy. There are no published data on intra-peritoneal pressures during transgastric procedures and surprisingly little data on intragastric pressures during routine gastroscopy. Overinflation of the peritoneal cavity can reduce diaphragmatic movement, cause impaired ventilation, reduce venous return with consequent fall in blood pressure and cause air embolism. Materials and Methods: Inflation pressure was monitored during a series of transgastric procedures including endoscopic full-thickness resection, transgastric suturing procedures and anastomosis in pigs weighing 28-37 kg. Direct measurements made using a trans-abdominal needle attached to a Storz laparoscope insufflator were compared with those made through a double channel Olympus endoscope. A modified valve was attached to the accessory port of the double channel endoscope which also allowed feed-back control of intraperitoneal pressure by automatic regulation and measurement of the volume of inflated air. Results: Measurements of intragastric pressure during a range of transgastric procedures, peak intraperitoneal pressures above 30 mm Hg were common. These are more than twice as high as those regarded as acceptable for conventional rigid laparoscopy. Overdistension was commonly observed and simply managed usually by needle venting of air through the abdominal wall during these procedures or aspiration through the gastroscope. Adverse effects on blood pressure and pulse rate were observed during some of these procedures. No fatalities or air embolism was observed. A prototype valve connector was tested using a Storz insufflator attached to the valve on a double channel gastroscope. The pressures correlated well with those measured via a transabdominal needle placed directly in the peritoneal cavity using a Verres technique. This technique more than halved the peak pressures measured during transgastric surgical techniques and allowed the use of safe automatic insufflation pressures with flexible endoscopes in the peritoneal cavity as are currently standard during laparoscopy. Conclusions: Direct measurements indicated that over-inflation of the peritoneal cavity was very common during experimental transgastric procedures using flexible endoscopes. A modified valve attached to the accessory port of a gastroscope halved the peak pressures and allowed automatic regulation and monitoring during transgastric surgical procedures.
Introduction: Current developments in intraluminal and natural orifice surgery are limited by issues of access, tissue manipulation, and approximation. This report describes an initial experience with a novel device for intraluminal manipulation and plication. Methods: The endoluminal system tested is comprised of a flexible, multilumen steerable access guide constructed using ShapeLockÒ Technology (TransPortTM) and a tissue approximation device (gProxTM) (USGI, San Clemente, CA). An adult pig was anesthetized and the stomach intubated using the access device preloaded with a standard Olympus gastroscope. The tissue approximation device was passed through the working channel, and under endoscopic visualization, manipulation of the gastric tissue was performed using a corkscrew type retractor, or using a combination of corkscrew retraction alternating with tissue grasping with the tissue approximation device, allowing tissue transfer or ‘‘hand over hand’’ type manipulation. Once an adequate and appropriate portion and location of tissue were so controlled, the tissue approximation device was used to place preloaded low-profile anchor pairs into the tissue and perform a secured plication under endoscopic guidance. Multiple maneuvers were performed in the area of the cardia via a retroflexed approach, and in the more distal stomach via an antegrade approach. The animal was euthanized at procedure completion and the plication sites examined. Results: Two endoscopists new to the device were able to place 6 anchor pairs in rapid fashion. The tissue manipulation capability was facile with both the corkscrew retractor and hand over hand approach. The plication sites revealed full thickness or deep muscularis tissue incorporation at all sites. In the cardia area, this created a ridge of thick, deep folds along a concentric line below the gastroesophageal junction. Conclusion: The gProx approximation device is a novel endoluminal tool which, in concert with the TransPort access platform, can allow endoluminal manipulation and plication of deep muscular or full thickness tissue anywhere within the gastric lumen. Further study of the device’s utility and durability in augmenting the area of the angle of His or achieving other types of gastric tissue approximation endoluminally is warranted.
723 Transgastric Endoscopic Pyloroplasty with Full-Thickness Gastric and Duodenal Myotomy and Sutured Closure Per-Ola Park, Annette Fritscher-Ravens, Maria Bergstrom, Sandy Mosse, Paul Swain 721 Closure of Gastric Perforation with a Novel Tissue Anchoring Device Kazuki Sumiyama, Christopher J. Gostout, Elizabeth Rajan, Timothy A. Bakken, Jodie L. Deters, Mary A. Knipschield Background: With the increasing use of endoscopic treatments, there is greater risk for creating an iatrogenic perforation in the GI tract. Urgent endoscopic repair with clips has been reported as well-tolerated and a therapeutic option. However, it is difficult to apply clips for secure full thickness closure of large defects Aims: To assess the ability of a tissue anchoring device to close a large iatrogenic gastric perforation in a porcine model. Methods: A dual channel therapeutic scope was used (Olympus America, NY). The prototype tissue anchoring device consisted of two flexible retractable needle catheters and a bifurcated nylon suture with two distal t-tags and one proximal sliding t-tag. Before the procedure, both ends of the suture attached with two distal t-tags were loaded inside of the retractable needle catheters. Full-thickness puncture with each needle separately place each of the two distal t-tags on each side of the perforation. the free proximal tag was then grasped and the sliding T-tag was firmly pushed to cinch the suture. Six pigs were studied under general anesthesia. Two perforations over 2 cm in size were created for each pig along the greater curvature and the anterior wall with a combination of needle knife and sphincterotome. They were each closed with 3-5 tissue anchors sets, depending on the length of the perforation. One week after the repair, follow up endoscopy and necropsy were performed to evaluate treated sites. Results: Twelve perforations were closed with 48 tissue anchors. All animals survived for one week without clinical complications. Follow up endoscopy and necropsy revealed all tissue anchors firmly in place with healed perforations. However, three of twenty four tissue anchors (12.5%) used at the anterior wall penetrated surrounding organs; two penetrated the liver and one penetrated the anterior abdominal wall. Conclusions: Full thickness closure with a new tissue anchoring device successfully repaired large iatrogenic gastric perforations. The preliminary results of this study are encouraging for providing reliable and safe endoscopic closure of iatrogenic perforations.
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Background: Pyloroplasty is a common surgical procedure which may be performed for gastric outlet obstruction due a variety of causes including duodenal ulceration, hypertrophic and generalized smooth muscle disorders, vagal nerve injury following upper GI surgery including esophagectomy, proximal gastrectomy and fundoplication. Materials and Methods: Pyloroplasty was performed in acute and survival studies in 4 pigs (28-35 kg). A double channel gastroscope was used for the procedure. In pigs more retroflexion is required for pyloric intubation than in humans since the lesser curve is shorter and greater curve more distensible. The position of the bile duct orifice was checked first since this is located in the proximal bulb in pigs and is in line with the prepyloric bulge, which is a prominent feature of pig anatomy. Using grasping forceps to hold the duodenal side of the tissue and expose the deep muscle a needle knife incision was made through the full thickness of the pyloric muscle. A stitch was placed in the deep muscle at the apex of the duodenal incision and another at the proximal edge of the gastric incision. These were tied together thus opening up the pylorus. Further stitches were placed on either side of the first stitch until the defect was effectively closed and water-tight. Suturing was performed using a 19 gauge needle on a flexible shaft passed through one channel of the double channel gastroscope. The threads were locked together in pairs. Results: The technique was used in 4 pigs including two survival studies. Incisions were 1.5-2 cm in length. 3 or 4 pairs of stitches were placed in each animal. Intra-peritoneal pressure measurements in 2 animals using a Verres needle technique indicated a rise or retro-peritoneal pressure indicating that the incisions were full-thickness. There was no significant bleeding or other complications. Grasping forceps were found helpful to hold the tissue during suturing. Stitch placement was not limited by the markedly retroflexed position of the endoscope. The surviving animals appeared fully recovered on awaking from the anesthetic and there were no complications. It was demonstrably easier to enter the pylorus after these experiments. The average time for these procedures was 30 minutes. Post-mortem examination showed effective healing of the incision and there was no evidence of leakage, peritoneal inflammation or peritonitis. Conclusions: Pyloroplasty with full-thickness pyloromyotomy and transverse closure of the linear incision thus substantially increasing the diameter of the pylorus was accomplished using a simple flexible endosurgical technique testing a new flexible suturing system.
Volume 63, No. 5 : 2006 GASTROINTESTINAL ENDOSCOPY AB101
720 Measurements of Intraperitoneal Pressure During Flexible Transgastric Surgery and the Development of a Feed-Back Control Valve for Regulating Pressure Per-Ola Park, Maria Bergstrom, Paul Swain
722 Initial Experience with a Novel Endoscopic Device Allowing Intragastric Manipulation and Plication John D. Mellinger, Bruce V. Macfadyen, Richard A. Kozarek, Nathaniel D. Soper, Desmond H. Birkett, Lee L. Swanstrom
Background: Transgastric surgical techniques using flexible endoscopes have been introduced without monitoring intra-peritoneal pressure or feedback control of inflation, which are standard during conventional rigid laparoscopy. There are no published data on intra-peritoneal pressures during transgastric procedures and surprisingly little data on intragastric pressures during routine gastroscopy. Overinflation of the peritoneal cavity can reduce diaphragmatic movement, cause impaired ventilation, reduce venous return with consequent fall in blood pressure and cause air embolism. Materials and Methods: Inflation pressure was monitored during a series of transgastric procedures including endoscopic full-thickness resection, transgastric suturing procedures and anastomosis in pigs weighing 28-37 kg. Direct measurements made using a trans-abdominal needle attached to a Storz laparoscope insufflator were compared with those made through a double channel Olympus endoscope. A modified valve was attached to the accessory port of the double channel endoscope which also allowed feed-back control of intraperitoneal pressure by automatic regulation and measurement of the volume of inflated air. Results: Measurements of intragastric pressure during a range of transgastric procedures, peak intraperitoneal pressures above 30 mm Hg were common. These are more than twice as high as those regarded as acceptable for conventional rigid laparoscopy. Overdistension was commonly observed and simply managed usually by needle venting of air through the abdominal wall during these procedures or aspiration through the gastroscope. Adverse effects on blood pressure and pulse rate were observed during some of these procedures. No fatalities or air embolism was observed. A prototype valve connector was tested using a Storz insufflator attached to the valve on a double channel gastroscope. The pressures correlated well with those measured via a transabdominal needle placed directly in the peritoneal cavity using a Verres technique. This technique more than halved the peak pressures measured during transgastric surgical techniques and allowed the use of safe automatic insufflation pressures with flexible endoscopes in the peritoneal cavity as are currently standard during laparoscopy. Conclusions: Direct measurements indicated that over-inflation of the peritoneal cavity was very common during experimental transgastric procedures using flexible endoscopes. A modified valve attached to the accessory port of a gastroscope halved the peak pressures and allowed automatic regulation and monitoring during transgastric surgical procedures.
Introduction: Current developments in intraluminal and natural orifice surgery are limited by issues of access, tissue manipulation, and approximation. This report describes an initial experience with a novel device for intraluminal manipulation and plication. Methods: The endoluminal system tested is comprised of a flexible, multilumen steerable access guide constructed using ShapeLockÒ Technology (TransPortTM) and a tissue approximation device (gProxTM) (USGI, San Clemente, CA). An adult pig was anesthetized and the stomach intubated using the access device preloaded with a standard Olympus gastroscope. The tissue approximation device was passed through the working channel, and under endoscopic visualization, manipulation of the gastric tissue was performed using a corkscrew type retractor, or using a combination of corkscrew retraction alternating with tissue grasping with the tissue approximation device, allowing tissue transfer or ‘‘hand over hand’’ type manipulation. Once an adequate and appropriate portion and location of tissue were so controlled, the tissue approximation device was used to place preloaded low-profile anchor pairs into the tissue and perform a secured plication under endoscopic guidance. Multiple maneuvers were performed in the area of the cardia via a retroflexed approach, and in the more distal stomach via an antegrade approach. The animal was euthanized at procedure completion and the plication sites examined. Results: Two endoscopists new to the device were able to place 6 anchor pairs in rapid fashion. The tissue manipulation capability was facile with both the corkscrew retractor and hand over hand approach. The plication sites revealed full thickness or deep muscularis tissue incorporation at all sites. In the cardia area, this created a ridge of thick, deep folds along a concentric line below the gastroesophageal junction. Conclusion: The gProx approximation device is a novel endoluminal tool which, in concert with the TransPort access platform, can allow endoluminal manipulation and plication of deep muscular or full thickness tissue anywhere within the gastric lumen. Further study of the device’s utility and durability in augmenting the area of the angle of His or achieving other types of gastric tissue approximation endoluminally is warranted.
723 Transgastric Endoscopic Pyloroplasty with Full-Thickness Gastric and Duodenal Myotomy and Sutured Closure Per-Ola Park, Annette Fritscher-Ravens, Maria Bergstrom, Sandy Mosse, Paul Swain 721 Closure of Gastric Perforation with a Novel Tissue Anchoring Device Kazuki Sumiyama, Christopher J. Gostout, Elizabeth Rajan, Timothy A. Bakken, Jodie L. Deters, Mary A. Knipschield Background: With the increasing use of endoscopic treatments, there is greater risk for creating an iatrogenic perforation in the GI tract. Urgent endoscopic repair with clips has been reported as well-tolerated and a therapeutic option. However, it is difficult to apply clips for secure full thickness closure of large defects Aims: To assess the ability of a tissue anchoring device to close a large iatrogenic gastric perforation in a porcine model. Methods: A dual channel therapeutic scope was used (Olympus America, NY). The prototype tissue anchoring device consisted of two flexible retractable needle catheters and a bifurcated nylon suture with two distal t-tags and one proximal sliding t-tag. Before the procedure, both ends of the suture attached with two distal t-tags were loaded inside of the retractable needle catheters. Full-thickness puncture with each needle separately place each of the two distal t-tags on each side of the perforation. the free proximal tag was then grasped and the sliding T-tag was firmly pushed to cinch the suture. Six pigs were studied under general anesthesia. Two perforations over 2 cm in size were created for each pig along the greater curvature and the anterior wall with a combination of needle knife and sphincterotome. They were each closed with 3-5 tissue anchors sets, depending on the length of the perforation. One week after the repair, follow up endoscopy and necropsy were performed to evaluate treated sites. Results: Twelve perforations were closed with 48 tissue anchors. All animals survived for one week without clinical complications. Follow up endoscopy and necropsy revealed all tissue anchors firmly in place with healed perforations. However, three of twenty four tissue anchors (12.5%) used at the anterior wall penetrated surrounding organs; two penetrated the liver and one penetrated the anterior abdominal wall. Conclusions: Full thickness closure with a new tissue anchoring device successfully repaired large iatrogenic gastric perforations. The preliminary results of this study are encouraging for providing reliable and safe endoscopic closure of iatrogenic perforations.
www.giejournal.org
Background: Pyloroplasty is a common surgical procedure which may be performed for gastric outlet obstruction due a variety of causes including duodenal ulceration, hypertrophic and generalized smooth muscle disorders, vagal nerve injury following upper GI surgery including esophagectomy, proximal gastrectomy and fundoplication. Materials and Methods: Pyloroplasty was performed in acute and survival studies in 4 pigs (28-35 kg). A double channel gastroscope was used for the procedure. In pigs more retroflexion is required for pyloric intubation than in humans since the lesser curve is shorter and greater curve more distensible. The position of the bile duct orifice was checked first since this is located in the proximal bulb in pigs and is in line with the prepyloric bulge, which is a prominent feature of pig anatomy. Using grasping forceps to hold the duodenal side of the tissue and expose the deep muscle a needle knife incision was made through the full thickness of the pyloric muscle. A stitch was placed in the deep muscle at the apex of the duodenal incision and another at the proximal edge of the gastric incision. These were tied together thus opening up the pylorus. Further stitches were placed on either side of the first stitch until the defect was effectively closed and water-tight. Suturing was performed using a 19 gauge needle on a flexible shaft passed through one channel of the double channel gastroscope. The threads were locked together in pairs. Results: The technique was used in 4 pigs including two survival studies. Incisions were 1.5-2 cm in length. 3 or 4 pairs of stitches were placed in each animal. Intra-peritoneal pressure measurements in 2 animals using a Verres needle technique indicated a rise or retro-peritoneal pressure indicating that the incisions were full-thickness. There was no significant bleeding or other complications. Grasping forceps were found helpful to hold the tissue during suturing. Stitch placement was not limited by the markedly retroflexed position of the endoscope. The surviving animals appeared fully recovered on awaking from the anesthetic and there were no complications. It was demonstrably easier to enter the pylorus after these experiments. The average time for these procedures was 30 minutes. Post-mortem examination showed effective healing of the incision and there was no evidence of leakage, peritoneal inflammation or peritonitis. Conclusions: Pyloroplasty with full-thickness pyloromyotomy and transverse closure of the linear incision thus substantially increasing the diameter of the pylorus was accomplished using a simple flexible endosurgical technique testing a new flexible suturing system.
Volume 63, No. 5 : 2006 GASTROINTESTINAL ENDOSCOPY AB101