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Endoscopic Closure of Duodenal Perforations By Means of An Over the Scope Clip (OTSC): A Randomized Controlled Porcine Study
Abstracts
devices (Cook Medical, NC, USA) was used in two 35 kg Yorkshire pigs: 1) The T-bar anchor consists of a distal metal tag attached to a nylon suture with a proximal sliding tag. 2) The loop anchor consists of a metal tag with a central loop through which sutures can pass. Both T-bar and loop anchor are housed within a 19 gauge flexible retractable needle device. After 10 ml of submucosal saline injection, two T-bar anchors with attached nylon sutures were placed into the submucosal space beneath the targeted lesion. The distal edge of the nylon was pulled out through the mouth. Next, the loop anchor with the threaded suture was placed by the needle device into the opposite wall of the lesion in order to optimize counter traction. After all three anchors were placed (2 T-bar and 1 loop anchor), counter traction was applied to the targeted lesion by simply pulling on the nylon suture 9 (pulley action). ESD was then conducted using a standard needle knife and prototype hook knife (Cook). A standard gastroscope and electrocoagulation was used. Results: We successfully deployed T-bars and loop anchors in both animals, resulting in continuous traction on the lesion through the entire ESD procedure. There were no complications. The specimen was also easily retrieved by pulling on the attached nylon sutures. After ESD, the specimen, and the location of the T-bar was evaluated. Both specimen were successfully resected at the submucosal layer which included the T-bars. In both cases, only 10 ml of a single submucosal injection was required for the entire ESD. Once T-bar and loop anchors were successfully placed, the entire ESD procedure was completed in 8-10 minutes. Conclusion: This novel T-bar assisted ESD technique allowed for excellent visualization by providing counter traction on the lesion. It may also reduce submucosal injection and procedure time. Further testing and refinements are underway.
731 A Novel Lumenal Apposition Device for Therapeutic Endoscopy Kenneth F. Binmoeller, Janak N. Shah, John Lunsford, Hoang G. Phan, Fiona Sander Introduction: Today, interventional endoscopy includes therapeutic translumenal procedures such as pseudocyst drainage and celiac plexus blockade. Future advances in therapeutic endoscopy will optimize and broaden the delivery of minimally invasive therapy to organs and tissues surrounding the GI lumen under endoscopic ultrasound (EUS) guidance. In the forefront will be translumenal bile duct and gallbladder drainage. These procedures require a new technology platform to enable robust lumenal apposition that: (1) is stable and well tolerated in GI tract, (2) holds the lumens in close apposition without leakage, (3) does not cause pressure necrosis and (4) causes fistula formation and tissue fusion. Aim: We describe the design and features of a new Lumenal Apposition Device (LAD) and provide initial test results. Methods: The LAD is a collapsible braided structure delivered through a 10.5Fr catheter. The proximal and distal ends of the device selfexpand to a diameter larger than the central section, thereby forming a dualflanged anchor capable of holding adjacent tissues in close apposition. The central section forms a continuous 9mm lumen through which fluid can flow unobstructed from one lumen to the other. The proximal and distal flanges hold soft tissue in firm apposition without causing pressure necrosis. Bench-top measurements of the pressure exerted on tissue by the LAD flanges were obtained using an ex-vivo test fixture and porcine stomach tissue. Chronic porcine survival studies were also conducted in which a LAD was placed between the stomach and gall bladder of four survival animals. Flange pressure, tissue reaction and bile drainage was measured or monitored. Results: The force exerted by the LAD flanges was 0.150.20lbs based on a tissue thickness of 8mm. Survival animals were sacrificed at 2 and 6 weeks, with data pending on two animals, presently at 1 and 2 weeks. All animals were free of infection and showed no behavioral changes for the duration of the study. The LAD was well-tolerated by both the stomach and gall bladder tissue, as verified by gross necropsy inspection. Bile flow was visualized endoscopically throughout the study. EUS exams also confirmed the close apposition of the gall bladder to the stomach. Conclusion: This novel luminal apposition device represents an improvement that can extend the boundaries of therapeutic endoscopy by enabling a robust and reliable conduit between lumens in and around the GI tract.
732 Endoscopic Closure of Duodenal Perforations By Means of An Over the Scope Clip (OTSC): A Randomized Controlled Porcine Study Daniel Von Renteln, Hans U. Rudolph, Arthur R. Schmidt, Maria Gieselmann, Tamara E. Gutmann, Karel Caca Background and study aims: Duodenal perforations during upper endoscopy are rare. However, since invasive endoscopic techniques like EMR, ESD, and EUS are increasingly used, so may the incidence of duodenal perforations. Surgical repair is still the mainstay of therapy but associated with significant morbidity and mortality. Endoscopic closure of such perforations would represent a minimal invasive alternative and was therefore evaluated in a randomized controlled animal study. Material and Methods: In 24 domestic pigs a 1cm large duodenal perforation was endoscopically created using needle knife incision with the animals under general anaesthesia. After randomisation pigs were assigned to either surgical repair (nZ12) or endoscopic closure (nZ12). Endoscopic repair was performed using
AB122 GASTROINTESTINAL ENDOSCOPY Volume 69, No. 5 : 2009
a 2T160 double channel upper endoscope (Olympus, Hamburg, Germany), a Twin Grasper and 12mm traumatic Over The Scope Clips (OTSC, Ovesco, Germany). Surgical repair was achieved by open laparotomy. Pressurized leak tests of the perforation closures were performed following necropsy. Additionally pressurized leak test were performed in an ex vivo evaluation of hand-sewn closures of 1cm large scalpel incisions (nZ18) and of healthy duodenal tissue (nZ18). Tissue for ex vivo evaluation was obtained from freshly killed pigs. Results: Mean time for endoscopic closure was 5 min. (Range 3-8 min., SD 2). No complication occurred during any of the closure procedures. At necropsy and macroscopic examination all OTSC and surgical closures showed complete incorporation and closure of the duodenal needle-knife incisions. Pressurized leak test showed a mean burst pressure of 166 mmHg (Range 80-260, SD 65) for OTSC closures and a mean burst pressure of 143 mmHg (Range 30-300, SD 83) for surgical sutures. Ex vivo handsewn sutures of 1cm scalpel incisions exhibited a mean burst pressure of 81 mmHg (Range 43-140, SD 31) and ex vivo duodenal tissue exhibited a burst pressure of 247 mmHg (Range 200-300, SD 35). Ex vivo duodenal tissue burst pressure was significantly higher compared to OTSC closure (p!0.01), in vivo surgical closures (p!0.01), and ex vivo hand-sewn closures (p!0.01). OTSC closures were comparable to surgical closures (pZ0.461) and superior to ex vivo hand-sewn closures (p!0.01). In vivo surgical closures were superior to ex vivo hand-sewn closures (p!0.01). Conclusions: Endoscopic closure by means of the OTSC system exhibits comparable results to in vivo surgical sutures and seems suitable to attempt closure of 1cm large duodenal perforations.
733 First Clinical Experience of Submucosal Endoscopic Esophageal Myotomy for Esophageal Achalasia with No Skin Incision Haruhiro Inoue, Hitomi Minami, Hitoshi Satodate, Shin-Ei Kudo Background: Gold standard therapeutic approach for esophageal achalasia is recently laparoscopic Heller-Dor myotomy. But it still demands at least 5 abdominal skin incisions for trocar placement. Pasricha et al. reported a method of submucosal endoscopic esophageal myotomy with no skin incision in experimental model. We conducted preliminary clinical application of modified Pascricha technique as peroral endoscopic myotomy (POEM) for esophageal achalasia. Methods: In the middle part of the esophagus 3-cm longitudinal mucosal incision was put as a mucosal entry to submucosal space. Submucosal tunnel was created down to gastric cardia by the techniques of ESD using triangle-tip knife. Inner circular muscle bundle was dissected from 3 cm distal to mucosal entry. Dissection continued down to gastric cardia inducing total 7-cm length inner circular muscle defect. Thickened esophageal muscle bundle was totally dissected. Mucosal entry was closed using endoscopic clipping device. Clinical application of POEM was approved by IRB in Showa University Northern Yokohama Hospital. Informed consent was obtained from the patient. Results: Thirty-six year-old male who had a two-year lasting symptom of dysphasia received POEM. Barium swallowing study before and after procedure demonstrated total releasing of thickened LES. Operating time was 120 minutes in total. Post-operative course was uneventful. Dysphagia symptom totally disappeared after procedure. Conclusions: First successful clinical case of POEM was reported. This result supports further clinical application of POEM. Long-term results should be followed carefully in the future.
734 Predictive Factor of Local Recurrence After Endoscopic Resection of Large Esophageal Squamous Cell Carcinoma Ryu Ishihara, Yoji Takeuchi, Noriya Uedo, Hiroyasu Iishi, Koji Higashino, Masaharu Tatsuta Background: Recently the accumulated clinical experience and formal outcome studies have suggested a satisfactory prognosis following endoscopic resection (ER), and ER is now being used increasingly for the treatment of esophageal cancer. However, we sometimes experience local recurrence after ER. Selection of adequate treatment strategy depending on the tumor character is important to avoid local recurrence, especially when we treat larger lesions. To minimize local recurrence, we investigated the pre-treatment risk factors for local recurrence after ER of large esophageal cancers. Methods: ER using endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) was indicated for lesions without ulcer or obvious protrusion suggesting invasion to a deeper part of the submucosal layer. From September 1994 to June 2007, we treated 449 esophageal
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devices (Cook Medical, NC, USA) was used in two 35 kg Yorkshire pigs: 1) The T-bar anchor consists of a distal metal tag attached to a nylon suture with a proximal sliding tag. 2) The loop anchor consists of a metal tag with a central loop through which sutures can pass. Both T-bar and loop anchor are housed within a 19 gauge flexible retractable needle device. After 10 ml of submucosal saline injection, two T-bar anchors with attached nylon sutures were placed into the submucosal space beneath the targeted lesion. The distal edge of the nylon was pulled out through the mouth. Next, the loop anchor with the threaded suture was placed by the needle device into the opposite wall of the lesion in order to optimize counter traction. After all three anchors were placed (2 T-bar and 1 loop anchor), counter traction was applied to the targeted lesion by simply pulling on the nylon suture 9 (pulley action). ESD was then conducted using a standard needle knife and prototype hook knife (Cook). A standard gastroscope and electrocoagulation was used. Results: We successfully deployed T-bars and loop anchors in both animals, resulting in continuous traction on the lesion through the entire ESD procedure. There were no complications. The specimen was also easily retrieved by pulling on the attached nylon sutures. After ESD, the specimen, and the location of the T-bar was evaluated. Both specimen were successfully resected at the submucosal layer which included the T-bars. In both cases, only 10 ml of a single submucosal injection was required for the entire ESD. Once T-bar and loop anchors were successfully placed, the entire ESD procedure was completed in 8-10 minutes. Conclusion: This novel T-bar assisted ESD technique allowed for excellent visualization by providing counter traction on the lesion. It may also reduce submucosal injection and procedure time. Further testing and refinements are underway.
731 A Novel Lumenal Apposition Device for Therapeutic Endoscopy Kenneth F. Binmoeller, Janak N. Shah, John Lunsford, Hoang G. Phan, Fiona Sander Introduction: Today, interventional endoscopy includes therapeutic translumenal procedures such as pseudocyst drainage and celiac plexus blockade. Future advances in therapeutic endoscopy will optimize and broaden the delivery of minimally invasive therapy to organs and tissues surrounding the GI lumen under endoscopic ultrasound (EUS) guidance. In the forefront will be translumenal bile duct and gallbladder drainage. These procedures require a new technology platform to enable robust lumenal apposition that: (1) is stable and well tolerated in GI tract, (2) holds the lumens in close apposition without leakage, (3) does not cause pressure necrosis and (4) causes fistula formation and tissue fusion. Aim: We describe the design and features of a new Lumenal Apposition Device (LAD) and provide initial test results. Methods: The LAD is a collapsible braided structure delivered through a 10.5Fr catheter. The proximal and distal ends of the device selfexpand to a diameter larger than the central section, thereby forming a dualflanged anchor capable of holding adjacent tissues in close apposition. The central section forms a continuous 9mm lumen through which fluid can flow unobstructed from one lumen to the other. The proximal and distal flanges hold soft tissue in firm apposition without causing pressure necrosis. Bench-top measurements of the pressure exerted on tissue by the LAD flanges were obtained using an ex-vivo test fixture and porcine stomach tissue. Chronic porcine survival studies were also conducted in which a LAD was placed between the stomach and gall bladder of four survival animals. Flange pressure, tissue reaction and bile drainage was measured or monitored. Results: The force exerted by the LAD flanges was 0.150.20lbs based on a tissue thickness of 8mm. Survival animals were sacrificed at 2 and 6 weeks, with data pending on two animals, presently at 1 and 2 weeks. All animals were free of infection and showed no behavioral changes for the duration of the study. The LAD was well-tolerated by both the stomach and gall bladder tissue, as verified by gross necropsy inspection. Bile flow was visualized endoscopically throughout the study. EUS exams also confirmed the close apposition of the gall bladder to the stomach. Conclusion: This novel luminal apposition device represents an improvement that can extend the boundaries of therapeutic endoscopy by enabling a robust and reliable conduit between lumens in and around the GI tract.
732 Endoscopic Closure of Duodenal Perforations By Means of An Over the Scope Clip (OTSC): A Randomized Controlled Porcine Study Daniel Von Renteln, Hans U. Rudolph, Arthur R. Schmidt, Maria Gieselmann, Tamara E. Gutmann, Karel Caca Background and study aims: Duodenal perforations during upper endoscopy are rare. However, since invasive endoscopic techniques like EMR, ESD, and EUS are increasingly used, so may the incidence of duodenal perforations. Surgical repair is still the mainstay of therapy but associated with significant morbidity and mortality. Endoscopic closure of such perforations would represent a minimal invasive alternative and was therefore evaluated in a randomized controlled animal study. Material and Methods: In 24 domestic pigs a 1cm large duodenal perforation was endoscopically created using needle knife incision with the animals under general anaesthesia. After randomisation pigs were assigned to either surgical repair (nZ12) or endoscopic closure (nZ12). Endoscopic repair was performed using
AB122 GASTROINTESTINAL ENDOSCOPY Volume 69, No. 5 : 2009
a 2T160 double channel upper endoscope (Olympus, Hamburg, Germany), a Twin Grasper and 12mm traumatic Over The Scope Clips (OTSC, Ovesco, Germany). Surgical repair was achieved by open laparotomy. Pressurized leak tests of the perforation closures were performed following necropsy. Additionally pressurized leak test were performed in an ex vivo evaluation of hand-sewn closures of 1cm large scalpel incisions (nZ18) and of healthy duodenal tissue (nZ18). Tissue for ex vivo evaluation was obtained from freshly killed pigs. Results: Mean time for endoscopic closure was 5 min. (Range 3-8 min., SD 2). No complication occurred during any of the closure procedures. At necropsy and macroscopic examination all OTSC and surgical closures showed complete incorporation and closure of the duodenal needle-knife incisions. Pressurized leak test showed a mean burst pressure of 166 mmHg (Range 80-260, SD 65) for OTSC closures and a mean burst pressure of 143 mmHg (Range 30-300, SD 83) for surgical sutures. Ex vivo handsewn sutures of 1cm scalpel incisions exhibited a mean burst pressure of 81 mmHg (Range 43-140, SD 31) and ex vivo duodenal tissue exhibited a burst pressure of 247 mmHg (Range 200-300, SD 35). Ex vivo duodenal tissue burst pressure was significantly higher compared to OTSC closure (p!0.01), in vivo surgical closures (p!0.01), and ex vivo hand-sewn closures (p!0.01). OTSC closures were comparable to surgical closures (pZ0.461) and superior to ex vivo hand-sewn closures (p!0.01). In vivo surgical closures were superior to ex vivo hand-sewn closures (p!0.01). Conclusions: Endoscopic closure by means of the OTSC system exhibits comparable results to in vivo surgical sutures and seems suitable to attempt closure of 1cm large duodenal perforations.
733 First Clinical Experience of Submucosal Endoscopic Esophageal Myotomy for Esophageal Achalasia with No Skin Incision Haruhiro Inoue, Hitomi Minami, Hitoshi Satodate, Shin-Ei Kudo Background: Gold standard therapeutic approach for esophageal achalasia is recently laparoscopic Heller-Dor myotomy. But it still demands at least 5 abdominal skin incisions for trocar placement. Pasricha et al. reported a method of submucosal endoscopic esophageal myotomy with no skin incision in experimental model. We conducted preliminary clinical application of modified Pascricha technique as peroral endoscopic myotomy (POEM) for esophageal achalasia. Methods: In the middle part of the esophagus 3-cm longitudinal mucosal incision was put as a mucosal entry to submucosal space. Submucosal tunnel was created down to gastric cardia by the techniques of ESD using triangle-tip knife. Inner circular muscle bundle was dissected from 3 cm distal to mucosal entry. Dissection continued down to gastric cardia inducing total 7-cm length inner circular muscle defect. Thickened esophageal muscle bundle was totally dissected. Mucosal entry was closed using endoscopic clipping device. Clinical application of POEM was approved by IRB in Showa University Northern Yokohama Hospital. Informed consent was obtained from the patient. Results: Thirty-six year-old male who had a two-year lasting symptom of dysphasia received POEM. Barium swallowing study before and after procedure demonstrated total releasing of thickened LES. Operating time was 120 minutes in total. Post-operative course was uneventful. Dysphagia symptom totally disappeared after procedure. Conclusions: First successful clinical case of POEM was reported. This result supports further clinical application of POEM. Long-term results should be followed carefully in the future.
734 Predictive Factor of Local Recurrence After Endoscopic Resection of Large Esophageal Squamous Cell Carcinoma Ryu Ishihara, Yoji Takeuchi, Noriya Uedo, Hiroyasu Iishi, Koji Higashino, Masaharu Tatsuta Background: Recently the accumulated clinical experience and formal outcome studies have suggested a satisfactory prognosis following endoscopic resection (ER), and ER is now being used increasingly for the treatment of esophageal cancer. However, we sometimes experience local recurrence after ER. Selection of adequate treatment strategy depending on the tumor character is important to avoid local recurrence, especially when we treat larger lesions. To minimize local recurrence, we investigated the pre-treatment risk factors for local recurrence after ER of large esophageal cancers. Methods: ER using endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) was indicated for lesions without ulcer or obvious protrusion suggesting invasion to a deeper part of the submucosal layer. From September 1994 to June 2007, we treated 449 esophageal
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