a device for the deployment of internal esophageal chitosan bandage

1
T1479 Endoscopic Mucosal Resection (EMR) for Early Gastric Neoplasia (EGN): Western Experience Katja Deinert, Brigitte Schumacher, Horst Neuhaus EMR of EGN is potentially curative if the lesion is confined to the mucosa and complete resection (CR) can be achieved. Experience with this approach is limited in Western countries. We prospectively studied the efficacy and safety of EMR in consecutive patients with gastric adenoma (GA) or mucosal early gastric cancer (m- EGC) determined by biopsy studies. Methods: Eligible subjects were patients with GA or EGC limited to the mucosa according to endoscopy and EUS. EMR was performed by cap technique or submucosal dissection technique. CR was defined if histology showed neoplasia-free basal and lateral margins of en-bloc resected specimen. In case of piece meal resection basal margins had to be clear and two negative F/U endoscopies with biopsies had to show no more residuals. F/u was performed every 3 months during the first year and then every 6 months. Results: From 11/1999 to 9/2005 26 patients (mean age: 70 (47-82) years; m/f: 14/12) with GA (n Z 20) or EGC (n Z 6) were included. The lesions were located in the antrum (n Z 15), body (n Z 8) or cardia (n Z 3). They had a mean diameter of 25 (6-70) mm. Macroscopic classification revealed type 2a (n Z 15), 2aC2c (n Z 8), 1b (n Z 2) or 2c (n Z 1). The tumor was resected en-bloc in 11 patients. 15 patients underwent piecemeal resection in 1 (n Z 13) or 3 (n Z 2) session(s). In 10 patients intraoperative spurting bleeding and in two delayed bleeding occurred which could be endoscopically managed. One patient underwent surgery due to perforation without evidence of tumor-residuals. Small amounts of air on plain x-ray with no endoscopic evidence of a leak suggested microperforation in 2 cases which could be conservatively managed. One patient was treated for pneumonia due to aspiration. Histopathology showed EGC in 17 patients (m-type n Z 13, sm-type n Z 4) and GA in 9 patients (LGD Z 8, HGD Z 1). CR resection was achieved in 19 (73%) patients (en-bloc n Z 10, piecemeal n Z 9). Resection remained incomplete in 7 cases. Of the 7 patients with sm-infiltration or incomplete resection 4 underwent surgery and 3 underwent endoscopic re-treatment or f/u because of severe co-morbidities. Two patients were lost during f/u. During a medium f/u period of 71 (8-244) weeks 2 of 17 patients with CR developed recurrences (GA n Z 1, EGC n Z 1) which were treated by endoscopy (n Z 1) or surgery (n Z 1, pT1a, N0). F/u examinations were negative in the remaining 15 patients. Conclusion: EMR frequently reveals more advanced tumor stages of early gastric neoplasia with determination of basal infiltration. CR can be achieved in the majority of cases. The approach is potentially curative in case of CR and negative f/u endoscopies. T1480 Clinical Usefulness of Endoscopic Oblique Aspiration Mucosectomy for Superficial Esophageal Cancer Satoshi Tanabe, Wasaburo Koizumi, Katsuhiko Higuchi, Tohru Sasaki, Hiroyuki Mitomi, Katsunori Saigenji Introduction: Endoscopic mucosal resection (EMR) is now a widely accepted treatment option for superficial esophageal cancer. Recently, endoscopic submucosal dissection has been attempted, but found to cause complications such as perforation and bleeding. We retrospectively evaluated the outcomes of patients undergoing endoscopic aspiration mucosectomy with an oblique aspiration mucosectomy device (EOAM) to assess the clinical usefulness of this procedure. Aim & Methods: Between November 1999 and October 2005, endoscopic aspiration mucosectomy was performed in 80 patients with superficial esophageal cancer. All tumors were macroscopically classified as superficial type on the basis of preoperative endoscopic and EUS examinations. After confirming the lesion, glycerol was injected at the lesion margin. An oblique aspiration mucosectomy device (E type, Top Co., Ltd., Tokyo, Japan) was attached to the tip of a conventional scope. The lesion was aspirated into the device, and an opened snare was advanced. The lesion was ensnared and resected electrosurgically. Follow-up endoscopy was done every 6 months. Results: The rate of complete resection was 82.5% (66/80). The mean longest diameter of the resected specimens was 24 G 5 mm. The time required for resection was 38 G 21 minutes. There was no perforation. A submucosal hematoma occurred in 2 patients. Esophageal stenosis developed in 8 patients (10%). All strictures were managed by endoscopic dilation, and symptoms improved. Local recurrence occurred in 5 patients (6.0%), all of whom underwent follow-up endoscopic treatment. Conclusion: EOAM with a newly designed oblique mucosectomy device is safe and effective for the treatment of superficial esophageal cancer. T1481 Endoscopic Fistula Repair Using Full-Thickness Plication in the Porcine Stomach Model Ram Chuttani, Douglas Pleskow, Laura Ornellas Background: Iatrogenic gastric perforations and fistulae often require surgical repair. A durable endoscopic alternative to surgical repair could allow for reduced operative risks and post-operative surgical sequelae. Aim: To develop and evaluate an endoscopic technique to securely repair an iatrogenic gastric perforation using the Full-Thickness Plicator (NDO Surgical, Mansfield, MA) in the porcine stomach model. The Plicator deploys a transmural pre-tied polypropylene suture with two ePTFE suture pledgets. Methods: Gastric perforations of 10 mm to 15 mm in length were made along the greater curvature and fundus of 5 excised porcine stomachs. A modified Plicator implant was created whereby the suture lengths between the pledgets were reduced by 50% to 4 mm long. Using the tissue retractor of the Plicator, the gastric wall at the edge of the perforation was retracted into the arms of the Plicator. A single full-thickness plication was created to seal the perforation. Supplemental oxygen was connected to the endoscope to maintain gastric distension when required. Following plication, the integrity of the closure was evaluated by positioning the stomachs vertically and instilling a colored, carbonated liquid through the esophagus to fill and distend the stomach. Results: A single, endoscopically placed transmural suture enabled a secure closure of all gastric perforations up to 15 mm in length. There was no leakage of fluid upon complete stomach distension. Even though closure of larger perforations may be possible by creating 2 transmural plications, difficulty in maintaining gastric distension due to the large perforation is a limitation. Conclusions: 1. Endoscopic fistula repair up to 15 mm is possible using full-thickness plication. 2. The closure is completely secure with no leakage. 3. This technique may allow an easy endoscopic alternative to traditional surgical repair of perforations and fistulae. T1482 A Device for the Deployment of Internal Esophageal Chitosan Bandage Michael Owens, Amanda Senrud, Jeff Teach, Kenton Gregory Background: Recently developed internal chitosan bandages have been effective in achieving rapid hemostasis in large surgical and traumatic lacerations of the aorta, liver, lung, kidney and cardiac ventricles. We hypothesized the mucoadhesive, antimicrobial, coagulative, hemostatic, and accelerated wound healing properties of these bandages may be effective in the control of localized upper gastrointestinal bleeding. In order to study these effects, a device capable of endoluminal deployment for these or similar bandages is needed. Based on prior experience with the chitosan bandage, device requirements included direct endoscopic visualization, water impermeable barrier around the chitosan until deployment and 360 degree variable force for up to 180 seconds. Methods: We developed two methods for deployment: over the endoscope (OTS) and through-the-scope (TTS) balloon delivery devices. The OTS device consists of a 12 mm ID 30 mm length rigid cap fitting with external delivery balloon and sheath. A control arm and inflation tubing use the standard biopsy channel for deployment. The TTS method utilizes a modified wire guided 20 mm balloon dilation catheter and 16.7 mm ID GuardusÔ overtube acting as a sheath for water impermeability. To operate, the CRE balloon catheter is separated into two pieces, back-loaded and reconnected before intubation. However, if necessitated, the ability to use a guide wire or catheter irrigation was preserved via a 1.5mm ID tube-tube connector. Both devices were used with a 1T-130 Olympus gastroscope with 3.2 mm working channel, and ultrathin chitosan bandages with a thickness of 1.2 mm, and a circumference varying from 55 to 70 mm when deployed. Results: Successful deployments with tissue adhesion were achieved in 55% (6/11) esophageal OTS, 66% (2/3) duodenal OTS and 100% (8/8) esophageal TTS attempts made in porcine subjects using the devices. Deployment failure with the OTS device in both the esophagus and duodenum were caused by 1) sheath remaining attached to chitosan despite balloon deflation and repositioning 2) water permeating the sheath 3) tangling of the biopsy forceps and inflation catheter. Deployment failure in the duodenum alone occurred due to a small balloon size. Conclusion: Despite the bulk of a chitosan bandage, novel methods for delivery can attain adequate deployment and tissue adhesion in a circumferential, cylindrical pattern. The TTS device appears more effective, potentially due to the lack of complexity of design but may require refinements of water impermeability to avoid the need for an overtube. Abstracts www.giejournal.org Volume 63, No. 5 : 2006 GASTROINTESTINAL ENDOSCOPY AB237

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Page 1: A Device for the Deployment of Internal Esophageal Chitosan Bandage

T1479

Endoscopic Mucosal Resection (EMR) for Early Gastric Neoplasia

(EGN): Western ExperienceKatja Deinert, Brigitte Schumacher, Horst NeuhausEMR of EGN is potentially curative if the lesion is confined to the mucosa andcomplete resection (CR) can be achieved. Experience with this approach is limitedin Western countries. We prospectively studied the efficacy and safety of EMR inconsecutive patients with gastric adenoma (GA) or mucosal early gastric cancer (m-EGC) determined by biopsy studies. Methods: Eligible subjects were patients withGA or EGC limited to the mucosa according to endoscopy and EUS. EMR wasperformed by cap technique or submucosal dissection technique. CR was defined ifhistology showed neoplasia-free basal and lateral margins of en-bloc resectedspecimen. In case of piece meal resection basal margins had to be clear and twonegative F/U endoscopies with biopsies had to show no more residuals. F/u wasperformed every 3 months during the first year and then every 6 months. Results:From 11/1999 to 9/2005 26 patients (mean age: 70 (47-82) years; m/f: 14/12) with GA(n Z 20) or EGC (n Z 6) were included. The lesions were located in the antrum(n Z 15), body (n Z 8) or cardia (n Z 3). They had a mean diameter of 25 (6-70)mm. Macroscopic classification revealed type 2a (n Z 15), 2aC2c (n Z 8), 1b(n Z 2) or 2c (n Z 1). The tumor was resected en-bloc in 11 patients. 15 patientsunderwent piecemeal resection in 1 (n Z 13) or 3 (n Z 2) session(s). In 10 patientsintraoperative spurting bleeding and in two delayed bleeding occurred which couldbe endoscopically managed. One patient underwent surgery due to perforationwithout evidence of tumor-residuals. Small amounts of air on plain x-ray with noendoscopic evidence of a leak suggested microperforation in 2 cases which couldbe conservatively managed. One patient was treated for pneumonia due toaspiration. Histopathology showed EGC in 17 patients (m-type n Z 13, sm-type nZ 4) and GA in 9 patients (LGD Z 8, HGD Z 1). CR resection was achieved in 19(73%) patients (en-bloc n Z 10, piecemeal n Z 9). Resection remained incompletein 7 cases. Of the 7 patients with sm-infiltration or incomplete resection 4underwent surgery and 3 underwent endoscopic re-treatment or f/u because ofsevere co-morbidities. Two patients were lost during f/u. During a medium f/uperiod of 71 (8-244) weeks 2 of 17 patients with CR developed recurrences (GA n Z1, EGC n Z 1) which were treated by endoscopy (n Z 1) or surgery (n Z 1, pT1a,N0). F/u examinations were negative in the remaining 15 patients. Conclusion: EMRfrequently reveals more advanced tumor stages of early gastric neoplasia withdetermination of basal infiltration. CR can be achieved in the majority of cases. Theapproach is potentially curative in case of CR and negative f/u endoscopies.

T1480

Clinical Usefulness of Endoscopic Oblique Aspiration

Mucosectomy for Superficial Esophageal CancerSatoshi Tanabe, Wasaburo Koizumi, Katsuhiko Higuchi, Tohru Sasaki,Hiroyuki Mitomi, Katsunori SaigenjiIntroduction: Endoscopic mucosal resection (EMR) is now a widely acceptedtreatment option for superficial esophageal cancer. Recently, endoscopicsubmucosal dissection has been attempted, but found to cause complications suchas perforation and bleeding. We retrospectively evaluated the outcomes of patientsundergoing endoscopic aspiration mucosectomy with an oblique aspirationmucosectomy device (EOAM) to assess the clinical usefulness of this procedure.Aim & Methods: Between November 1999 and October 2005, endoscopic aspirationmucosectomy was performed in 80 patients with superficial esophageal cancer. Alltumors were macroscopically classified as superficial type on the basis ofpreoperative endoscopic and EUS examinations. After confirming the lesion,glycerol was injected at the lesion margin. An oblique aspiration mucosectomydevice (E type, Top Co., Ltd., Tokyo, Japan) was attached to the tip ofa conventional scope. The lesion was aspirated into the device, and an openedsnare was advanced. The lesion was ensnared and resected electrosurgically.Follow-up endoscopy was done every 6 months. Results: The rate of completeresection was 82.5% (66/80). The mean longest diameter of the resected specimenswas 24 G 5 mm. The time required for resection was 38 G 21 minutes. There wasno perforation. A submucosal hematoma occurred in 2 patients. Esophagealstenosis developed in 8 patients (10%). All strictures were managed by endoscopicdilation, and symptoms improved. Local recurrence occurred in 5 patients (6.0%),all of whom underwent follow-up endoscopic treatment. Conclusion: EOAM witha newly designed oblique mucosectomy device is safe and effective for thetreatment of superficial esophageal cancer.

T1481

Endoscopic Fistula Repair Using Full-Thickness Plication in the

Porcine Stomach ModelRam Chuttani, Douglas Pleskow, Laura OrnellasBackground: Iatrogenic gastric perforations and fistulae often require surgicalrepair. A durable endoscopic alternative to surgical repair could allow for reducedoperative risks and post-operative surgical sequelae. Aim: To develop and evaluatean endoscopic technique to securely repair an iatrogenic gastric perforation usingthe Full-Thickness Plicator (NDO Surgical, Mansfield, MA) in the porcine stomachmodel. The Plicator deploys a transmural pre-tied polypropylene suture with twoePTFE suture pledgets. Methods: Gastric perforations of 10 mm to 15 mm in lengthwere made along the greater curvature and fundus of 5 excised porcine stomachs. Amodified Plicator implant was created whereby the suture lengths between thepledgets were reduced by 50% to 4 mm long. Using the tissue retractor of thePlicator, the gastric wall at the edge of the perforation was retracted into the armsof the Plicator. A single full-thickness plication was created to seal the perforation.Supplemental oxygen was connected to the endoscope to maintain gastricdistension when required. Following plication, the integrity of the closure wasevaluated by positioning the stomachs vertically and instilling a colored, carbonatedliquid through the esophagus to fill and distend the stomach. Results: A single,endoscopically placed transmural suture enabled a secure closure of all gastricperforations up to 15 mm in length. There was no leakage of fluid upon completestomach distension. Even though closure of larger perforations may be possible bycreating 2 transmural plications, difficulty in maintaining gastric distension due tothe large perforation is a limitation. Conclusions: 1. Endoscopic fistula repair up to15 mm is possible using full-thickness plication. 2. The closure is completely securewith no leakage. 3. This technique may allow an easy endoscopic alternative totraditional surgical repair of perforations and fistulae.

T1482

A Device for the Deployment of Internal Esophageal Chitosan

BandageMichael Owens, Amanda Senrud, Jeff Teach, Kenton GregoryBackground: Recently developed internal chitosan bandages have been effective inachieving rapid hemostasis in large surgical and traumatic lacerations of the aorta,liver, lung, kidney and cardiac ventricles. We hypothesized the mucoadhesive,antimicrobial, coagulative, hemostatic, and accelerated wound healing properties ofthese bandages may be effective in the control of localized upper gastrointestinalbleeding. In order to study these effects, a device capable of endoluminaldeployment for these or similar bandages is needed. Based on prior experiencewith the chitosan bandage, device requirements included direct endoscopicvisualization, water impermeable barrier around the chitosan until deployment and360 degree variable force for up to 180 seconds. Methods: We developed twomethods for deployment: over the endoscope (OTS) and through-the-scope (TTS)balloon delivery devices. The OTS device consists of a 12 mm ID � 30 mm lengthrigid cap fitting with external delivery balloon and sheath. A control arm andinflation tubing use the standard biopsy channel for deployment. The TTS methodutilizes a modified wire guided 20 mm balloon dilation catheter and 16.7 mm IDGuardus� overtube acting as a sheath for water impermeability. To operate, theCRE balloon catheter is separated into two pieces, back-loaded and reconnectedbefore intubation. However, if necessitated, the ability to use a guide wire orcatheter irrigation was preserved via a 1.5mm ID tube-tube connector. Both deviceswere used with a 1T-130 Olympus gastroscope with 3.2 mm working channel, andultrathin chitosan bandages with a thickness of 1.2 mm, and a circumferencevarying from 55 to 70 mm when deployed. Results: Successful deployments withtissue adhesion were achieved in 55% (6/11) esophageal OTS, 66% (2/3) duodenalOTS and 100% (8/8) esophageal TTS attempts made in porcine subjects using thedevices. Deployment failure with the OTS device in both the esophagus andduodenum were caused by 1) sheath remaining attached to chitosan despiteballoon deflation and repositioning 2) water permeating the sheath 3) tangling ofthe biopsy forceps and inflation catheter. Deployment failure in the duodenumalone occurred due to a small balloon size. Conclusion: Despite the bulk ofa chitosan bandage, novel methods for delivery can attain adequate deploymentand tissue adhesion in a circumferential, cylindrical pattern. The TTS deviceappears more effective, potentially due to the lack of complexity of design but mayrequire refinements of water impermeability to avoid the need for an overtube.

Abstracts

www.giejournal.org Volume 63, No. 5 : 2006 GASTROINTESTINAL ENDOSCOPY AB237