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Pyloric Suture Narrowing Trial to Treat Obesity (A Canine Model)
Abstracts
pain (3) and minor GI bleeding (2). Repeated measures analysis showed the mean rate of weight regain prior to DGJR was 3 lb per month and the mean rate of weight loss after DGJR was -0.26 lbs/mo (P!0.0001) using semi-parametric mixed model with genrealized linear estimation. The average weight loss was -17 lb at 6 months (-30.6%excess weight loss) and -15 lb at 12 months (-29.9% excess weight loss). Weight stabilization or weight loss was achieved in 96% (1 mo), 88% (3 mo), 80% (6 mo), 75% (9 mo) and 68% (12 mo). Beyond 12 mo, 65% had weight stabilization at a mean of 16.5 mo follow-up. Conclusions: DGJR is a safe and effective intervention for weight regain in post-RYGB patients. Twelve month data shows that DGJR alters weight trends, achieving statistically significant weight loss and/or stabilization of weight regain.
M1503 Endoscopic Submucosal Dissection of Large Colorectal Tumors Using a Novel Traction Device, Spring-Action "S-O Clip" for Traction Naoto Sakamoto, Taro Osada, Tomoyoshi Shibuya, Kazuko Beppu, Kenshi Matsumoto, Hiroki Mori, Kozaburo Nakae, Yoshihiro Igusa, Akihiko Kurosawa, Masato Kawabe, Akihito Nagahara, Michiro Otaka, Tatsuo Ogihara, Sumio Watanabe Background and Aim: Endoscopic submucosal dissection (ESD) allows en bloc resection of large gastrointestinal neoplasms, regardless of their size; however, technical difficulties associated with ESD in the colorectum make it less widely applied in the treatment of tumors in this region. To address this difficulty, we designed a rubber strip-based traction device, termed ‘‘S-O clip’’, and reported previously that ESD with this device was effective for complete resection of large, superficial colorectal neoplasms (Endoscopy 2008; 40: E94 -95). Thereafter, it was reported the use of a spring traction device, similar to ours but consisting only of a spring with nylon loops (without clip), for gastric ESD. We describe a novel, spring-action ‘‘S-O clip’’ (Spring S-O clip) that improves the facility of clip use during ESD of colorectal tumors. To evaluate the efficacy and safety of ‘‘Spring S-O clip’’ for ESD of colorectal neoplasms. Methods: The ‘‘Spring S-O clip’’ consists of a metallic clip attached to the end of a 7 mm long and 1.8 mm wide spring, which is connected at its other end to a double nylon loop. It can be passed through an endoscope instrument channel. This length of the spring, which is not altered by a 1 x g force, extends approximately ten-fold at 20 x g. After partially dissecting the submucosa, the clip is applied to the edge of the exfoliated mucosa. Then, a regular clip is applied on the colonic wall after having grasped the distal nylon loop attached to the previously delivered clip. The regular clip is usually applied in a location oral and opposite to the lesion, allowing for traction and therefore opening of the resection margin. This results in pulling up the lesion. Tractionassisted dissection using Spring S-O clip was performed on 7 superficial colorectal lesions. Results: In all 7 cases, a large, superficial neoplasm in the right-side colon was removed safely and successfully en bloc without complication. The mean size of the resected lesions was 29.4 7.4 mm, and the procedure time was 42.4 16.1minutes. Conclusions: These cases demonstrate that ‘‘Spring S-O clip’’-assisted ESD is safe and effective for en bloc resection of large superficial neoplasms in the right-side colon.
M1504 Endoscopic Vacuum-Assisted Closure of Chronic Pelvic Abscesses Following Anterior Resection of the Rectum Alberto Arezzo, Aldo Garbarini, Mario Morino Background: Chronic abscesses after anastomotic leakage following anterior resection of the rectum is a challenging situation that requires careful evaluation of risks and benefits in the management, as the possibility of a definitive abdominoperineal amputation of the rectum is not remote. A new conservative treatment of acute anastomotic leakage after anterior resection of the rectum has been recently proposed with considerable success rate. The aim of the report is to demonstrate the possibility of treatment of misdiagnosed chronic abscesses as well. Materials and Methods: Two patients who underwent rectal resection 24 and 34 months respectively before our observation, both submitted to chemo- and radio-therapy, and suffering of a chronic pelvic abscess located in front of the holy bone, were recruited. One has a diverting stoma, while the other had it closed already after primary surgery. Both underwent a novel treatment consisting of an endoscopic vacuum-assisted closure attempt (Endosponge, BBraun, Germany). The main feature of this new method is the endoscopically assisted placement of an open-cell sponge connected to a vacuum device into the abscess cavity via an introducer device. The fistula orifice is first cannulated, and then dilated by means of a 20 mm balloon. The endoscope is advanced into the cavity. The outer sheath of the introducer system is advanced under endoscopic control over the scope till the end of the cavity. The endoscope is removed leaving the outer sheath in place. The sponge is introduced into the distal end of the sheath. The sponge is pushed through the outer sheath by the inner sleeve and finally released in the cavity. The evacuation tube coming out of the anus of the patient is connected to a vacuum device. The sponge system is changed every 48-72 h, till the cavity is fully covered of a new epithelium and smaller that 10 mm in diameter. Results The first patients
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obtained a complete healing in 45 days and 17 sessions. The second patient is still under treatment but after 3 weeks and 9 sessions of treatment the abscess cavity is reduced to !50%. The patient without diverting stoma was allowed to enteral nutrition for the first week, to avoid faeces formation and transit. The comfort of the procedure was judged good by both patients. Non signs of abdominal sepsis was demonstrated during treatment. Conclusions Endoscopic vacuum-assisted closure may be proposed as a new efficacious modality for treating not only acute anastomotic leakage following anterior resection but also chronic and misdiagnosed pelvic abscesses. Further studies will demonstrate the real effectiveness and safety of the treatment.
M1505 First Clinical Trial of Endoscopic Submucosal Resection (ESD) of Early Gastric Neoplasia with a Water-Jet Hybridknife (ESDH) Horst Neuhaus, Rupert Mayershofer, Katja Wirths, Brigitte Schumacher, Alexander Seelhoff, Michael Vieth, Markus D. Enderle Background: According to Asian studies ESD is effective for curative treatment of early gastric neoplasia. However ESD is technically difficult, time-consuming and less safe than EMR. Some of these limitations may be overcome by use of a new HybridKnife which can be used for combination of a high pressure water-jet and electrosurgical interventions (Erbe Germany). Aim: The primary objective is to achieve complete resection of defined early gastric neoplasia by ESDH. Secondary objectives are to minimize the number of resected specimen and to determine the procedure related morbidity. Methods: Patients with gastric neoplasia were included according to current Japanese guidelines. All procedures were done under sedation with propofol. The tip of the HybridKnife was used for setting coagulation markers around the targeted area with a safety margin. The same knife was used for submucosal needleless injection of saline solution with a waterjet-system and cutting for circumferential incision and dissection of the lesion. Intraoperative bleeding was treated with coagulation by use of the knife or a hemostatic forceps in case of failure. Clips were used for closure of perforations. Results: Thirteen patients (8 f; median age 66 (53-93) yr; ASA score 1 (1-3) were included. Histology of biopsies had shown gastric adenocarcinoma in 8 cases and adenoma in 5. The mean diameter of the lesions was 25 mm (15-30 mm). Complete en-bloc resection of the targeted area could be achieved in all cases. The median operation time was 85.5 min (55-180 min). Intraoperative bleedings required the use of hemostatic forceps in 3 cases. A perforation in one case was definitely managed with clips. A 93 yr old patient died the night after ESDH due to cardiac arrest w/o evidence of relation to the procedure. Histology confirmed complete resection in 10/12 cases and infiltration of the lateral tumor margin in 2. It revealed adenocarcinoma (T1 stages: 5 m1, 1 m3, 1 sm1) in 7 cases and adenoma (LGD) in 3. In 2 cases histology showed no neoplasia but chronic gastritis and intestinal metaplasia, resp. After 3 months EGD demonstrated no neoplasia in 11/12 patients and a small metachronous lesion in 1. Conclusions: ESDH is feasible and simplifies the procedure because exchange of accessories is rarely needed. The easy repetition of needleless submucosal injection can accelerate interventions with no need for special solutions. These first clinical results demonstrate that ESDH is a promising new ESD technique for complete and safe enbloc resection of early gastric neoplasia.
M1506 Pyloric Suture Narrowing Trial to Treat Obesity (A Canine Model) Anil K. Vegesna, Ramashesai Besetty, Mansoor I. Tiwana, Lewis T. Bright, Annapurna Korimilli, Milton April, Alexis Agelan, Larry S. Miller Objectives: To develop an endoscopic method to treat obesity by decreasing gastric emptying. This is accomplished by narrowing the gastric pylorus endoscopically, thus causing early and prolonged satiety and subsequently decreasing caloric consumption. Methods: 16 young dogs (still growing) were randomized into 3 groups (8 Suture, 4 Sham, and 4 Control). Using an endoscopic suturing device (Bard, EndoCinch), sutures were placed across the pylorus in the suture group. Gastric emptying studies were conducted on all dogs using Octanoic acid breath tests. All dogs were monitored for food intake and weight gain/loss. Results: Food consumption - The suture dogs decrease their food consumption by a mean of 48%, p! 0.002. The sham and control dogs showed an 8% increase in food consumed. This is a 56% difference(p!0.0002). Gastric emptying. - There was a delay in gastric emptying between the pre-suturing baseline and first and second post-suturing gastric emptying tests by 14% (p!0.02) and 32% (p!0.03) respectively. In the sham plus control dogs, there was no change in gastric emptying. There was a significant delay in the post-suture dogs gastric emptying vs. the sham plus control dogs gastric emptying by 45% (p!0.02). Weight gain or loss -The suture dogs lost 13% of their initial body weight p!0.03. The sham and control dogs gained 14% of their initial body weight. Comparing the suture dogs to the control plus sham group, there was a 26% difference in the change in weight, p!0.0002 Conclusions: A significant decrease in weight and food consumption and a significant prolongation of gastric emptying was demonstrated in the pre-suture vs. the post-suture dogs and between the suture dogs vs. the sham plus control dogs.
Volume 69, No. 5 : 2009 GASTROINTESTINAL ENDOSCOPY AB259
pain (3) and minor GI bleeding (2). Repeated measures analysis showed the mean rate of weight regain prior to DGJR was 3 lb per month and the mean rate of weight loss after DGJR was -0.26 lbs/mo (P!0.0001) using semi-parametric mixed model with genrealized linear estimation. The average weight loss was -17 lb at 6 months (-30.6%excess weight loss) and -15 lb at 12 months (-29.9% excess weight loss). Weight stabilization or weight loss was achieved in 96% (1 mo), 88% (3 mo), 80% (6 mo), 75% (9 mo) and 68% (12 mo). Beyond 12 mo, 65% had weight stabilization at a mean of 16.5 mo follow-up. Conclusions: DGJR is a safe and effective intervention for weight regain in post-RYGB patients. Twelve month data shows that DGJR alters weight trends, achieving statistically significant weight loss and/or stabilization of weight regain.
M1503 Endoscopic Submucosal Dissection of Large Colorectal Tumors Using a Novel Traction Device, Spring-Action "S-O Clip" for Traction Naoto Sakamoto, Taro Osada, Tomoyoshi Shibuya, Kazuko Beppu, Kenshi Matsumoto, Hiroki Mori, Kozaburo Nakae, Yoshihiro Igusa, Akihiko Kurosawa, Masato Kawabe, Akihito Nagahara, Michiro Otaka, Tatsuo Ogihara, Sumio Watanabe Background and Aim: Endoscopic submucosal dissection (ESD) allows en bloc resection of large gastrointestinal neoplasms, regardless of their size; however, technical difficulties associated with ESD in the colorectum make it less widely applied in the treatment of tumors in this region. To address this difficulty, we designed a rubber strip-based traction device, termed ‘‘S-O clip’’, and reported previously that ESD with this device was effective for complete resection of large, superficial colorectal neoplasms (Endoscopy 2008; 40: E94 -95). Thereafter, it was reported the use of a spring traction device, similar to ours but consisting only of a spring with nylon loops (without clip), for gastric ESD. We describe a novel, spring-action ‘‘S-O clip’’ (Spring S-O clip) that improves the facility of clip use during ESD of colorectal tumors. To evaluate the efficacy and safety of ‘‘Spring S-O clip’’ for ESD of colorectal neoplasms. Methods: The ‘‘Spring S-O clip’’ consists of a metallic clip attached to the end of a 7 mm long and 1.8 mm wide spring, which is connected at its other end to a double nylon loop. It can be passed through an endoscope instrument channel. This length of the spring, which is not altered by a 1 x g force, extends approximately ten-fold at 20 x g. After partially dissecting the submucosa, the clip is applied to the edge of the exfoliated mucosa. Then, a regular clip is applied on the colonic wall after having grasped the distal nylon loop attached to the previously delivered clip. The regular clip is usually applied in a location oral and opposite to the lesion, allowing for traction and therefore opening of the resection margin. This results in pulling up the lesion. Tractionassisted dissection using Spring S-O clip was performed on 7 superficial colorectal lesions. Results: In all 7 cases, a large, superficial neoplasm in the right-side colon was removed safely and successfully en bloc without complication. The mean size of the resected lesions was 29.4 7.4 mm, and the procedure time was 42.4 16.1minutes. Conclusions: These cases demonstrate that ‘‘Spring S-O clip’’-assisted ESD is safe and effective for en bloc resection of large superficial neoplasms in the right-side colon.
M1504 Endoscopic Vacuum-Assisted Closure of Chronic Pelvic Abscesses Following Anterior Resection of the Rectum Alberto Arezzo, Aldo Garbarini, Mario Morino Background: Chronic abscesses after anastomotic leakage following anterior resection of the rectum is a challenging situation that requires careful evaluation of risks and benefits in the management, as the possibility of a definitive abdominoperineal amputation of the rectum is not remote. A new conservative treatment of acute anastomotic leakage after anterior resection of the rectum has been recently proposed with considerable success rate. The aim of the report is to demonstrate the possibility of treatment of misdiagnosed chronic abscesses as well. Materials and Methods: Two patients who underwent rectal resection 24 and 34 months respectively before our observation, both submitted to chemo- and radio-therapy, and suffering of a chronic pelvic abscess located in front of the holy bone, were recruited. One has a diverting stoma, while the other had it closed already after primary surgery. Both underwent a novel treatment consisting of an endoscopic vacuum-assisted closure attempt (Endosponge, BBraun, Germany). The main feature of this new method is the endoscopically assisted placement of an open-cell sponge connected to a vacuum device into the abscess cavity via an introducer device. The fistula orifice is first cannulated, and then dilated by means of a 20 mm balloon. The endoscope is advanced into the cavity. The outer sheath of the introducer system is advanced under endoscopic control over the scope till the end of the cavity. The endoscope is removed leaving the outer sheath in place. The sponge is introduced into the distal end of the sheath. The sponge is pushed through the outer sheath by the inner sleeve and finally released in the cavity. The evacuation tube coming out of the anus of the patient is connected to a vacuum device. The sponge system is changed every 48-72 h, till the cavity is fully covered of a new epithelium and smaller that 10 mm in diameter. Results The first patients
www.giejournal.org
obtained a complete healing in 45 days and 17 sessions. The second patient is still under treatment but after 3 weeks and 9 sessions of treatment the abscess cavity is reduced to !50%. The patient without diverting stoma was allowed to enteral nutrition for the first week, to avoid faeces formation and transit. The comfort of the procedure was judged good by both patients. Non signs of abdominal sepsis was demonstrated during treatment. Conclusions Endoscopic vacuum-assisted closure may be proposed as a new efficacious modality for treating not only acute anastomotic leakage following anterior resection but also chronic and misdiagnosed pelvic abscesses. Further studies will demonstrate the real effectiveness and safety of the treatment.
M1505 First Clinical Trial of Endoscopic Submucosal Resection (ESD) of Early Gastric Neoplasia with a Water-Jet Hybridknife (ESDH) Horst Neuhaus, Rupert Mayershofer, Katja Wirths, Brigitte Schumacher, Alexander Seelhoff, Michael Vieth, Markus D. Enderle Background: According to Asian studies ESD is effective for curative treatment of early gastric neoplasia. However ESD is technically difficult, time-consuming and less safe than EMR. Some of these limitations may be overcome by use of a new HybridKnife which can be used for combination of a high pressure water-jet and electrosurgical interventions (Erbe Germany). Aim: The primary objective is to achieve complete resection of defined early gastric neoplasia by ESDH. Secondary objectives are to minimize the number of resected specimen and to determine the procedure related morbidity. Methods: Patients with gastric neoplasia were included according to current Japanese guidelines. All procedures were done under sedation with propofol. The tip of the HybridKnife was used for setting coagulation markers around the targeted area with a safety margin. The same knife was used for submucosal needleless injection of saline solution with a waterjet-system and cutting for circumferential incision and dissection of the lesion. Intraoperative bleeding was treated with coagulation by use of the knife or a hemostatic forceps in case of failure. Clips were used for closure of perforations. Results: Thirteen patients (8 f; median age 66 (53-93) yr; ASA score 1 (1-3) were included. Histology of biopsies had shown gastric adenocarcinoma in 8 cases and adenoma in 5. The mean diameter of the lesions was 25 mm (15-30 mm). Complete en-bloc resection of the targeted area could be achieved in all cases. The median operation time was 85.5 min (55-180 min). Intraoperative bleedings required the use of hemostatic forceps in 3 cases. A perforation in one case was definitely managed with clips. A 93 yr old patient died the night after ESDH due to cardiac arrest w/o evidence of relation to the procedure. Histology confirmed complete resection in 10/12 cases and infiltration of the lateral tumor margin in 2. It revealed adenocarcinoma (T1 stages: 5 m1, 1 m3, 1 sm1) in 7 cases and adenoma (LGD) in 3. In 2 cases histology showed no neoplasia but chronic gastritis and intestinal metaplasia, resp. After 3 months EGD demonstrated no neoplasia in 11/12 patients and a small metachronous lesion in 1. Conclusions: ESDH is feasible and simplifies the procedure because exchange of accessories is rarely needed. The easy repetition of needleless submucosal injection can accelerate interventions with no need for special solutions. These first clinical results demonstrate that ESDH is a promising new ESD technique for complete and safe enbloc resection of early gastric neoplasia.
M1506 Pyloric Suture Narrowing Trial to Treat Obesity (A Canine Model) Anil K. Vegesna, Ramashesai Besetty, Mansoor I. Tiwana, Lewis T. Bright, Annapurna Korimilli, Milton April, Alexis Agelan, Larry S. Miller Objectives: To develop an endoscopic method to treat obesity by decreasing gastric emptying. This is accomplished by narrowing the gastric pylorus endoscopically, thus causing early and prolonged satiety and subsequently decreasing caloric consumption. Methods: 16 young dogs (still growing) were randomized into 3 groups (8 Suture, 4 Sham, and 4 Control). Using an endoscopic suturing device (Bard, EndoCinch), sutures were placed across the pylorus in the suture group. Gastric emptying studies were conducted on all dogs using Octanoic acid breath tests. All dogs were monitored for food intake and weight gain/loss. Results: Food consumption - The suture dogs decrease their food consumption by a mean of 48%, p! 0.002. The sham and control dogs showed an 8% increase in food consumed. This is a 56% difference(p!0.0002). Gastric emptying. - There was a delay in gastric emptying between the pre-suturing baseline and first and second post-suturing gastric emptying tests by 14% (p!0.02) and 32% (p!0.03) respectively. In the sham plus control dogs, there was no change in gastric emptying. There was a significant delay in the post-suture dogs gastric emptying vs. the sham plus control dogs gastric emptying by 45% (p!0.02). Weight gain or loss -The suture dogs lost 13% of their initial body weight p!0.03. The sham and control dogs gained 14% of their initial body weight. Comparing the suture dogs to the control plus sham group, there was a 26% difference in the change in weight, p!0.0002 Conclusions: A significant decrease in weight and food consumption and a significant prolongation of gastric emptying was demonstrated in the pre-suture vs. the post-suture dogs and between the suture dogs vs. the sham plus control dogs.
Volume 69, No. 5 : 2009 GASTROINTESTINAL ENDOSCOPY AB259