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Mo1531 Feasibility of Using a Novel Triangulation Device to Perform Flexible Endoscopic Suturing in a Porcine Model
Abstracts
cholangiocarcinoma (nZ2), pancreatic cancer (nZ1) and gallbladder cancer (nZ1) invading duodenum. The baseline characteristics including age, location of bleeding tumor, and Blatchford score were not different in both groups. There was a trend toward lower re-bleeding at 14 days (pZ0.06) and 30 days in the Hemospray group (pZ0.22). No additional interventions needed in the hemospray group during admission. The 30-day mortality rate in the hemospray group was three times lower than the conventional therapy group. (Table). Conclusions: Hemospray is a promising therapy for the initial hemostasis in upper GI bleeding from tumor as it can hold the hemostasis during the first 30 days and this may allow enough time before consideration to provide the appropriate additional intervention. Table. Parameters and outcomes in Hemospray versus non-hemospray treatment
Parameters and outcomes Age (meanSD; years) Sex (%male) Blatchford scores(meanSD) Total blood transfusion (meanSD;unit) Number of total EGD (meanSD) Additional intervention performed during first 10day (%) Additional intervention performed during admission (%) 14-day re-bleeding rate (%) 30-day re-bleeding rate (%) Length of hospital stay (meanSD;day) 30-day mortality rate (%)
Hemospray group (N[9)
Conventional endoscopic treatment group (N[9)
pvalue
64.210.7 88.9 9.03.5 10.616.8
61.714.0 66.7 7.93.9 5.43.9
0.52 0.50 0.49 0.39
1.00
1.40.73
0.10
0
22.2
1.00
0
55.6
0.22
11.1 22.2 27.323.2
66.7 66.7 21.014.4
0.06 0.22 0.55
11.1
33.3
0.63
healing after endoscopic submucosal dissection (ESD). Complications from ESD, however, may prevent patients from commencing the prescribed course of three oral ingestions per day immediately after an ESD is performed. Aims: In this preclinical study we developed a novel 2% rebamipide solution for submucosal injection agent in ESD, used it for ESD experimentally in porcine stomachs,and examined the quality and speed of ulcer healing after the procedure. Methods: Three domestic female pigs of about 30 kg underwent ESD. ESDs of 30 mm in diameter were performed at four sites (anterior and posterior walls of both the upper body and lower body) in the stomach of each of three pigs. An endoscopist blinded to the test agents performed the ESD with matrix alone at two sites (control group) and with the 2% rebamipide solution at the other two sites (rebamipide group). One pig was sacrificed 1 week later (pig 1) and two pigs were sacrificed 4 weeks later (pigs 2 and 3). Examination 1: We evaluated healing speed once a week using endoscopic ulcer staging. Examination 2: We evaluated the quality of the ulcer scar histopathologically. Result: Examination 1. Ulcer healing evaluated by ulcer staging in the rebamipide group was as follows: at 1 week, H1, A2 in pig 1, H1, A2 in pig 2, and A2, A2 in pig 3; at 2 weeks, H2, H1 in pig 2 and H2, H2 in pig 3; at 3 weeks, S1, S1 in pig 2 and S1, S1 in pig 3; at 4 weeks, S1, S1 in pig 2 and S2, S2 in pig 3. The corresponding evaluation in the controls was as follows: at 1 week, H1, A2 in pig 1, H1, A2 in pig 2, and A2, A1 in pig 3; at 2 weeks, H2, H2 in pig 2 and S1, A2 in pig 3; at 3 weeks, S1, S1 in pig 2 and S2, H1 in pig 3; at 4 weeks, S1, S1 in pig 2 and S2, H2 in pig 3. There were no significant differences between the rebamipide group and control group evaluated by ulcer staging, but the folds into the center of the ulcer scar were smoother and more uniform in the rebamipide group than in the control group at 4 weeks after the ESD. Examination 2. The ulcers at 1 week were not observably different between the two groups. At 4 weeks, however, mucosal healing was conspicuously better in the rebamipide group than in the control group, with a thicker and more uniform mucosal layer. Conclusion: The 2% rebamipide solution assessed as a novel submucosal injection agent in this study increased the healing speed and improved ulcer healing after ESD.
Mo1531 Feasibility of Using a Novel Triangulation Device to Perform Flexible Endoscopic Suturing in a Porcine Model Mostafa Ibrahim*1, Vincent Huberty1, Martin Hiernaux2, Alexandre Chau2, Jacques Deviere1 1 Gastroenterology, Hepatopancreatology and Digestive oncology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium; 2 Endotools therapeutics, Gosselies, Belgium Introduction: Endoscopic suturing was reported recently but full thickness gastric sutures are still challenging due to the complexity of suturing maneuvers and lack of instrumental handiness, the latter could be reduced with a flexible triangulation system. Aim: To explore the technical feasibility of a novel triangulation platform “ENDOMINA Ò” to perform full thickness endoscopic suturing and anterio-posterior apposition into the stomach. Methods: ENDOMINA Ò (Endo Tools Therapeutics, Belgium) is a single usetriangulation platform,assembled on the endoscope into the stomach, that adds a 5 Fr bendable channel and a 5 Fr non bendable channel to an endoscope. ENDOMINA Ò is used in combination with TAPES Ò (Transmural Anterio-Posterior Endoscopic Stitcher) in the bendable channel with a preloaded tag and tightening system releaser. The steps of the procedure were (i) Identification of the anterior and posterior piercing points in the stomach. (ii) Mucosal ablation with coagulation current. (iii) Grasping of first point (iv) Introduction of TAPES in the bendable channel. (v) Transmural piercing and deposition of first tag. (vi), Repetition of the same technique at the second point. (vii) Release and tightening of both transmural plicatures using the preloaded knot (viii). Results: Two complete sutures with knot release were achieved in 2 pigs. Mean time for the procedure was 90 minutes. Endoscopy follow up at 7 and 30 days confirmed the presence of the sutures in place and persistent antero-posterior application of the 2 transmural plicatures. Both pigs were sacrificed and tissue histology of resected suture area confirmed full thickness tissue apposition and fibrosis formation. No mortality or procedure related morbidities were reported in the 2 pigs with one month follow up. Conclusion: ENDOMINA-assisted endoscopic system can perform safely endoluminal suturing and knot-tying in live porcine models, achieving not only plicatures with serosa to serosa apposition but also antero-posterior apposition of the plicatures.
Mo1530 Efficacy of a 2% Rebamipide Solution As a Novel Submucosal Injection Agent for Gastric Endoscopic Submucosal Dissection Ai Fujimoto*, Yasutoshi Ochiai, Osamu Goto, Toshihiro Nishizawa, Rieko Nakamura, Tadateru Maehata, Satoshi Kinoshita, Seiji Sagara, Toshio Uraoka, Naohisa Yahagi Keio University, Tokyo, Japan Background: Rebamipide is a safe and widely used medication for oral administration to patients with gastritis or gastric ulcers. A combination therapy of proton pump inhibitor (PPI) and rebamipide was reported to effectively promote ulcer
AB454 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S : 2015
www.giejournal.org
cholangiocarcinoma (nZ2), pancreatic cancer (nZ1) and gallbladder cancer (nZ1) invading duodenum. The baseline characteristics including age, location of bleeding tumor, and Blatchford score were not different in both groups. There was a trend toward lower re-bleeding at 14 days (pZ0.06) and 30 days in the Hemospray group (pZ0.22). No additional interventions needed in the hemospray group during admission. The 30-day mortality rate in the hemospray group was three times lower than the conventional therapy group. (Table). Conclusions: Hemospray is a promising therapy for the initial hemostasis in upper GI bleeding from tumor as it can hold the hemostasis during the first 30 days and this may allow enough time before consideration to provide the appropriate additional intervention. Table. Parameters and outcomes in Hemospray versus non-hemospray treatment
Parameters and outcomes Age (meanSD; years) Sex (%male) Blatchford scores(meanSD) Total blood transfusion (meanSD;unit) Number of total EGD (meanSD) Additional intervention performed during first 10day (%) Additional intervention performed during admission (%) 14-day re-bleeding rate (%) 30-day re-bleeding rate (%) Length of hospital stay (meanSD;day) 30-day mortality rate (%)
Hemospray group (N[9)
Conventional endoscopic treatment group (N[9)
pvalue
64.210.7 88.9 9.03.5 10.616.8
61.714.0 66.7 7.93.9 5.43.9
0.52 0.50 0.49 0.39
1.00
1.40.73
0.10
0
22.2
1.00
0
55.6
0.22
11.1 22.2 27.323.2
66.7 66.7 21.014.4
0.06 0.22 0.55
11.1
33.3
0.63
healing after endoscopic submucosal dissection (ESD). Complications from ESD, however, may prevent patients from commencing the prescribed course of three oral ingestions per day immediately after an ESD is performed. Aims: In this preclinical study we developed a novel 2% rebamipide solution for submucosal injection agent in ESD, used it for ESD experimentally in porcine stomachs,and examined the quality and speed of ulcer healing after the procedure. Methods: Three domestic female pigs of about 30 kg underwent ESD. ESDs of 30 mm in diameter were performed at four sites (anterior and posterior walls of both the upper body and lower body) in the stomach of each of three pigs. An endoscopist blinded to the test agents performed the ESD with matrix alone at two sites (control group) and with the 2% rebamipide solution at the other two sites (rebamipide group). One pig was sacrificed 1 week later (pig 1) and two pigs were sacrificed 4 weeks later (pigs 2 and 3). Examination 1: We evaluated healing speed once a week using endoscopic ulcer staging. Examination 2: We evaluated the quality of the ulcer scar histopathologically. Result: Examination 1. Ulcer healing evaluated by ulcer staging in the rebamipide group was as follows: at 1 week, H1, A2 in pig 1, H1, A2 in pig 2, and A2, A2 in pig 3; at 2 weeks, H2, H1 in pig 2 and H2, H2 in pig 3; at 3 weeks, S1, S1 in pig 2 and S1, S1 in pig 3; at 4 weeks, S1, S1 in pig 2 and S2, S2 in pig 3. The corresponding evaluation in the controls was as follows: at 1 week, H1, A2 in pig 1, H1, A2 in pig 2, and A2, A1 in pig 3; at 2 weeks, H2, H2 in pig 2 and S1, A2 in pig 3; at 3 weeks, S1, S1 in pig 2 and S2, H1 in pig 3; at 4 weeks, S1, S1 in pig 2 and S2, H2 in pig 3. There were no significant differences between the rebamipide group and control group evaluated by ulcer staging, but the folds into the center of the ulcer scar were smoother and more uniform in the rebamipide group than in the control group at 4 weeks after the ESD. Examination 2. The ulcers at 1 week were not observably different between the two groups. At 4 weeks, however, mucosal healing was conspicuously better in the rebamipide group than in the control group, with a thicker and more uniform mucosal layer. Conclusion: The 2% rebamipide solution assessed as a novel submucosal injection agent in this study increased the healing speed and improved ulcer healing after ESD.
Mo1531 Feasibility of Using a Novel Triangulation Device to Perform Flexible Endoscopic Suturing in a Porcine Model Mostafa Ibrahim*1, Vincent Huberty1, Martin Hiernaux2, Alexandre Chau2, Jacques Deviere1 1 Gastroenterology, Hepatopancreatology and Digestive oncology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium; 2 Endotools therapeutics, Gosselies, Belgium Introduction: Endoscopic suturing was reported recently but full thickness gastric sutures are still challenging due to the complexity of suturing maneuvers and lack of instrumental handiness, the latter could be reduced with a flexible triangulation system. Aim: To explore the technical feasibility of a novel triangulation platform “ENDOMINA Ò” to perform full thickness endoscopic suturing and anterio-posterior apposition into the stomach. Methods: ENDOMINA Ò (Endo Tools Therapeutics, Belgium) is a single usetriangulation platform,assembled on the endoscope into the stomach, that adds a 5 Fr bendable channel and a 5 Fr non bendable channel to an endoscope. ENDOMINA Ò is used in combination with TAPES Ò (Transmural Anterio-Posterior Endoscopic Stitcher) in the bendable channel with a preloaded tag and tightening system releaser. The steps of the procedure were (i) Identification of the anterior and posterior piercing points in the stomach. (ii) Mucosal ablation with coagulation current. (iii) Grasping of first point (iv) Introduction of TAPES in the bendable channel. (v) Transmural piercing and deposition of first tag. (vi), Repetition of the same technique at the second point. (vii) Release and tightening of both transmural plicatures using the preloaded knot (viii). Results: Two complete sutures with knot release were achieved in 2 pigs. Mean time for the procedure was 90 minutes. Endoscopy follow up at 7 and 30 days confirmed the presence of the sutures in place and persistent antero-posterior application of the 2 transmural plicatures. Both pigs were sacrificed and tissue histology of resected suture area confirmed full thickness tissue apposition and fibrosis formation. No mortality or procedure related morbidities were reported in the 2 pigs with one month follow up. Conclusion: ENDOMINA-assisted endoscopic system can perform safely endoluminal suturing and knot-tying in live porcine models, achieving not only plicatures with serosa to serosa apposition but also antero-posterior apposition of the plicatures.
Mo1530 Efficacy of a 2% Rebamipide Solution As a Novel Submucosal Injection Agent for Gastric Endoscopic Submucosal Dissection Ai Fujimoto*, Yasutoshi Ochiai, Osamu Goto, Toshihiro Nishizawa, Rieko Nakamura, Tadateru Maehata, Satoshi Kinoshita, Seiji Sagara, Toshio Uraoka, Naohisa Yahagi Keio University, Tokyo, Japan Background: Rebamipide is a safe and widely used medication for oral administration to patients with gastritis or gastric ulcers. A combination therapy of proton pump inhibitor (PPI) and rebamipide was reported to effectively promote ulcer
AB454 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5S : 2015
www.giejournal.org