A New Transoral Gastroplasty Device for GERD and Obesity

Abstracts

Prone vs Left Lateral Colonoscopy in Obese Patients

BMI Time to Cecum (min) Max Pain (0-10) Midazolam (mg) Fentanyl (mcg)

Prone Position

Left-Lateral Position

38 5 1.3 2.4 82

36 11 3.0 2.4 92

p p p p p

! ! ! Z Z

0.05 0.001 0.001 NS NS

months. Three patients with a long-segment stenosis (O 1 cm) experienced a recurrence, and it was statistically significant (P Z .003). Restenosis following treatment occurred in 1.6 month, mean and 2 sessions of treatment were repeated. All procedures were successfully completed within 10 minutes. None of the patients experienced threatening complications such as bleeding or perforation. Conclusions: Endoscopic incisional therapy using an Iso-Tome and an end-viewing endoscope fitted with a transparent hood in patients with anastomotic esophageal strictures is an easy, safe and feasible method for primary treatment. It appears to keep a longer rate of patency than bougie or balloon dilation. However, this study had a limited number of patients and a randomized, controlled study is required to verify these findings.

443 A Randomised Comparative Study Between Dilation By Electrocautery Incision and Savary Bougies for Benign Anastomotic Gastro-Esophageal Strictures Marjan L. Hordijk, Jeanin E. Hooft Van, Bettina E. Hansen, Paul Fockens, E. J. Kuipers

445 Randomized Controlled Study of Endoscopic Mucosal Resection (EMR) Versus Endoscopic Submucosal Dissection with a Waterjet Hybridknife (ESDH) of Esophageal Lesions in a Porcine Model Horst Neuhaus, Katja Wirths, Markus D. Enderle, Brigitte Schumacher

Introduction: A gastro-esophageal anastomosis is complicated by a stricture in 5-46% of patients. With Savary bougies (SB) repeated dilations are often required. Electrocautery incision (EI) has been shown excellent for anastomotic strictures refractory to SB.Study aims: To compare the efficacy of dilation with EI or SB in patients with an anastomotic stricture after esophageal resection with regard to objective and subjective criteria. Methods: Patients with dysphagia grade II (solids) or worse were randomized to EI or SB and followed up after 1, 3 and 6 month. Dilation took place with EI by needle knife incisions (Wilson Cook, Boston Scientific). The minimal diameter was 11 mm in EI and 16 mm in SB. Study endpoint was O5 dilations. Objective (weight change; success rate [percentage of patients with %5 dilations in 6 month]; time interval between dilations) and subjective criteria were compared (dysphagia; saliva, acid, bile regurgitation; coughing; enjoying meal; eating frequency; portion size; pain; patients’ tolerability of the procedure and perception of satisfaction after therapy). Results: 62 patients (50 male, 12 female, aged 41-76, mean 61.7) were randomized to EI or SB. Of the first treatments 75.8% were within 4 month after surgery. No complication of EI or SB was seen. Overall weight change was significant in favour of EI (mean þ0.8 kg vs. mean -2 kg, p Z 0.05). Between EI and SB was no significant difference in success rate (96.2% vs. 80.8%, p Z 0.08) and time interval between dilations (median 6 weeks, 95% confidence interval [CI] 3.1-8.9 vs. median 6 weeks, CI 4.4-7.6, p Z 0.73). Overall estimated stenosis length was significant longer in EI (0.2-5 cm, mean 1.35 vs. 0.2-2 cm, mean 0.55, p ! 0.001). To correct for this skewed distribution we analyzed the group of 17 patients with postoperative complications were the most extreme stenosis lengths were observed and EI and SB showed no significant difference in lengths (0.3-5 cm, mean 2 vs. 0.2-2 cm, mean 0.8, p Z 0.07). In this group EI showed a significant higher success rate (88.9% vs. 37.5%, p Z 0.03) and longer time interval between dilations (median 6 weeks, CI 4.1-7.9 vs. median 4 weeks, CI 3.3-4.7, p Z 0.04). Overall subjective criteria improved significant after therapy in both groups (p Z 0.03-p ! 0.001), though with EI patients’ tolerability of the procedure and perception of satisfaction after therapy were significant better (p Z 0.001, p Z 0.002). Conclusion: Overall patients with anastomotic esophageal strictures preferred EI above SB. Weight change was in favour of EI. Patients with postoperative complications needed less dilations and the time interval between dilations was longer with EI.

Introduction: Uncontrolled studies indicated that ESD is superior to EMR for enbloc resection of gastrointestinal mucosal lesions. However, ESD is technically difficult and seems to be more time-consuming and hazardous than EMR. In addition experience with this method is limited in the esophagus although there may be more clinical applications for esophageal lesions than for gastric lesions in Western countries. The objective of our study is to compare a new simplified ESD technique with conventional EMR. Methods and aims: The study was performed in 6 pigs under general anesthesia. A total of 25 esophageal areas with a diameter of 20 mm were marked with coagulation spots. These lesions were then randomized to either EMR by use of the cap technique or ESD. Submucosal injection of saline solution was used for both methods. ESD was done with a hybrid knife which allows cutting / coagulation as well as injection / flushing through an axial water-jet channel with a preselected pressure of a high pressure waterjet system (Erbe Jet 2). Intraoperative bleedings were treated with hemostatic forceps. Primary objective: to achieve complete resection of the lesions including the coagulation markers with no mucosal bridges; secondary objectives: to minimize the number of specimen, to determine the complication rate and procedural duration. Results: 13 lesions were randomized to EMRC and 12 to ESDH. ESDH achieved complete resection significantly more frequently than EMRC (10/12 versus 6/13 p Z 0.05). All ESDH resections were performed as a single piece whereas a mean (  SD) of 2.5  0.9 resections were needed for EMRC (p ! 0.05). Mean areas of the specimen were 4.7  0.7 cm2 in the ESDH group and 3.7  1.2 cm2 in the EMRC group (p ! 0.04). ESDH was performed with a larger amount of fluid for injection/flushing compared to EMRC (78.1  32.8 ml vs 20.9  7.6 ml; p ! 0.001). The procedural duration was longer for ESDH than for EMRC (28.2  11.9 min vs 12.2  4.9 min; p ! 0.001). ESDH and EMRC caused bleedings in 6/12 and 5/13 (p Z 0.09) of the cases, respectively. Hemostasis could be achieved in all cases. There was no perforation in both groups. Conclusions: This randomized controlled trial shows that ESDH significantly achieves complete resection of esophageal lesions more frequently with less number of specimen than EMRC. ESDH is more time-consuming but the procedural duration seems to be shorter than conventional ESD because there is no need for exchange of devices for injection and cutting. The easy use of water-jet assisted injection of large amount of fluids may explain that ESDH was as safe as EMRC in spite of the thin esophageal wall in a porcine model.

444 Endoscopic Incisional Therapy with Iso-Tome and Transparent Hood in Patients with Benign Anastomotic Esophageal Stricture Tae Hoon Lee, Suck-Ho Lee, Ji-Young Park, Jeong Hoon Park, Do Hyun Park, Il Kwun Chung, Hong-Soo Kim, Sang-Heum Park, Sun-Joo Kim, Su Jin Hong, Moon Sung Lee Background: Benign anastomotic stricture of the esophagus following surgical resection has been reported to occur in 5% to 46% of patients. There is a significant recurrence rate in bougie, or balloon dilation, which requires repeated dilation sessions to maintain the patency. Electrocautery treatment was proposed to be a good alternative treatment in several studies. Aim: Our study evaluated the efficacy of endoscopic incisional therapy using an Iso-Tome and an end-viewing endoscope fitted with a transparent hood in patients with benign anastomotic esophageal strictures, prospectively. Materials and Methods: A total of 24 patients having benign anastomotic esophageal strictures after total gastrectomy with gastrojejunostomy were treated with endoscopic incisional therapy using Iso-Tome under direct vision through a transparent hood to ensure a safety-margin. Radial incisions parallel to the longitude of the esophagus were carefully performed by pulling up the Iso-Tome, and terminated when the endoscope could easily pass without pressure to the stricture. The number (8-10 incisions) and the length of incisions were quantified to completely remove the rim of the stenosis. Clinical evaluation and EGD were carried out for every patient one month later and then followed-up during the next 18 months. Results: All 21 patients with a stricture shorter than 1cm in length were dilated successfully following a single incisional treatment, and it was not necessary to repeat the sessions during the following 18

AB90 GASTROINTESTINAL ENDOSCOPY Volume 67, No. 5 : 2008

446 A New Transoral Gastroplasty Device for GERD and Obesity Rudolf J. Stadlhuber, Fumiaki Yano, Sumeet K. Mittal, Raul J. Rosenthal, Richard I. Rothstein, Charles J. Filipi Background: Gastro-esophageal-reflux-disease and morbid obesity are significant health problems in the western world and are associated with morbidities and increasing costs. The common surgical therapy is either a laparoscopic or open operation. We are developing a device that allows a physician to create an endoscopic, full-thickness gastroplasty under conscious sedation; the primary goals being efficacy and durability of effect by reducing the diameter of the gastroesophageal junction (GERD) or the stomach volume (obesity). Methods: The gastroplasty is formed by a new dilator shaped device (SafesStitch Medical Inc.). The instrument consists of a flexible tube with an integrated excision and suture capsule on the distal end. A standard small caliber transnasal endoscope is introduced through the device for direct observation. A rigid distal capsule measuring 5  2cm in diameter contains a guillotine excision blade, vertical anchor needles for tissue holding and Adrenalin injection, and two needles each connected to a separate suture running through the device. Four full-thickness sutures are placed and two mucosal excisions down to the level of the muscularis propria are used for each stage of the gastroplasty. After correct positioning of the device under direct endoscopic visualization the gastric wall is pulled into the trough with 180 mm/Hg negative pressure. The two three-quarter-circle needles are actuated to rotate 360 through the captured tissue. The tissue is then injected with 8 cc of 1:200,000 adrenalin-solution to create tissue swelling for a safe cut in the correct gastric wall layer and hemostasis. The second suture excision cycle is performed by turning the device into the correct position and repeating the sequence. The

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Abstracts

sutures are then tied and cut with a flexible endoscopic device resulting in a fullthickness muscularis propria-to-muscularis propria apposition. Results: We performed pre clinical procedures with ex vivo porcine (n Z 45) and ex vivo human tissue (n Z 10) as well as in vivo porcine (n Z 5) and canine procedures (n Z 5). In each model we were able to create full-thickness gastroplasties at the gastroesophageal junction and within the proximal stomach. Excision overlap areas were inspected macroscopically and microscopically for safety. The GEJ circumference changes and the obesity gastroplasty outlet were measured endoscopically in ex vivo models and expected narrowing was observed in most animals. Conclusion: Pre-clinical work has demonstrated the feasibility of the new device and its intended procedures. Two survival canine studies are in progress and will direct further evolution of this new device and technique.

447 A Novel Device, Countertraction-Spring, Is Easier and Safer for Endoscopic Submucosal Dissection of Mucosal Stomach Cancer Nobuyuki Sakurazawa, Masao Miyashita, Shunji Kato, Teruo Kiyama, Tsutomu Nomura, Itsuro Fujita, Takeshi Okuda, Keiichi Okawa, Hideyuki Takata, Yoshinori Sakata, Goro Takahashi, Natsuki Seki, Katsuhiko Iwakiri, Takashi Tajiri Purpose: To safely perform endoscopic submucosal dissection (ESD) with a good field of view using a spring to apply countertraction during surgery. Methods: According to basic experiments, traction forces of 1-20 gram provide effective countertraction on the gastric mucosa. We invented a novel countertraction device that consists of a stainless steel-spring that is 2 mm in diameter, 2 cm long, and has a wire diameter of 0.1 mm, an approximately 10 fold stretch distance in this range of traction forces, and a nylon loop attached to each of its ends. (1) Allowing a 5 mm margin around the mucosal lesion, the entire circumference is incised. (2) The spring, set in the middle of a 2.5-mm diameter tube that passes through the 2.8-mm forceps channel of an endoscope, is introduced into the stomach via the forceps channel. (3) Countertraction is applied by attaching one of the loops to one end of the lesion with a clip, and attaching the other loop to the healthy mucosa on the other side. (4) The submucosal layer is dissected. (5) The clip attached to the mucosa on the other side is released, and the lesion and spring are retrieved. Results: After obtaining the patients’ informed consent, ESD with the novel device was performed on 5 male and 5 female patients between November 2006 and November 2007. The patients’ ages ranged from 64 to 82 years (mean: 72.6), and the locations of the tumors were: Lower, Less 6; Lower, Gre, 2; Lower, Post 1; and Middle-Upper, Less 1. According to macroscopic type, there were 8 IIa cases, 1 IIa þ IIc case, and 1 IIc case. Mean diameters of the lesions were 20.4 mm  14.5 mm; mean diameters of the resected specimens were 42.7 mm x 33.9 mm; mean fullcircumference incision time was 28 min; mean spring placement time was 4.7 min; and mean submucosal dissection time was 20.5 min. Dissection was possible with sufficient countertraction and a good field of view in every case. There were no complications, and the patients were discharged after a mean hospital stay of 7.8 days. With the exception of 1 case with final pathological diagnosis of adenoma (resection margin negative) and 1 case submucosal invasion 250 micrometer in which additional surgery was performed by positive vertical margin, the pathological findings showed that all of the cases were well differentiated mucosal cancers with negative resection margins and no vascular invasion, and that complete resection had been performed. Conclusion: The countertraction-spring provided favorable countertraction for submucosal dissection of mucosal stomach cancer and this device made the dissection technique easier and safer.

448 Magnetic Force Assisted Endoscopic Submucosal Dissection with Permalloy Tissue Anchors Kazuki Sumiyama, Takeshi Ohdaira, Keiichi Ikeda, Hisao Tajiri To improve en bloc resection rates of EMR for early GI cancers, ESD technique using an array of novel needle knives was developed. In this technique, a large diseased mucosa over 5cm can be freed from the muscularis propria by electrosurgical dissection using one of the many specialized needle knives. However, ESD is technically more difficult, labor intensive, and time consuming than any other EMR method. Tedious repetitive electrosurgical dissection under poor endoscopic vision of dissection plane is accompanied with higher risk of perforation and bleeding. Current major technical limitation in ESD is inability to create counter traction during the submucosal dissection process with ‘‘off-theshelf ’’ endoscopic system. Aims: To develop remote manipulation system of metallic tissue anchors to create arbitrary counter traction to facilitate ESD. Methods: We developed ‘‘multipurpose magnetic device for fixing multiple surgical tools and organs (m-DMSTO)’’. This system allowed intuitive manipulation of multiple surgical tools within body cavities. Surgical tools in this system are attached to super-paramagnetic material (permalloy) tissue anchors and remotely maneuvered with a needle-shaped magnetic manipulator. Also, the tools can be readily detached from the manipulator with extracorporeal magnetic force controller. The technical feasibility of ESD using m-DMSTO was studied in an anesthetized in vivo porcine model. A target mucosal lesion approximately 40mm in

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diameter was created with circular cauterized spots on the greater curvature of the stomach. Following saline submucosal injection, the lesion was circumferentially isolated with an insulated tip needle knife (IT knife). A permalloy clip was applied onto the edge of the isolated mucosa. The needle-shaped manipulator was percutaneouly inserted into the stomach via the anterior wall with modified PEG technique. The submucosal dissection was then performed with an IT-knife. In order to maintain clear vision of the dissection plane, the isolated mucosa was lifted by pulling the clip anchor with the magnetic manipulator. Results: The 40mm mucosal lesion was safely removed less than 10min. The overlying mucosa was effectively deflected away from the dissection plane during submucosal dissection with optimal multidirectional tissue traction by magnetic force. There was no operative complication such as perforation and bleeding. Conclusion: Remote tissue manipulation with m-DOMST system could provide optimal working field for the elsectrosurgical dissection in ESD. Magnetic force assisted ESD is technically feasible, safe and easy.

545 Capsule Endoscopy (CE) Re-Assessment in a High Volume Center (HVC) Identifies Significant Misinterpretations of the Community Gastroenterologists (CG) That May Impact Clinical Care Patricio Ibanez, Peter Simpson, Gil Y. Melmed, Shahab Mehdizadeh, Mamatha Sadda, Simon K. Lo Introduction: Standardized training for CE has not been well defined. It is currently assumed that an experienced gastroenterologist is capable of reading CE following a short training course. No published studies have assessed potential discrepancies in CE interpretation between the CG and those in the HVC. Method: We prospectively compared consecutive CE interpretations sent from CG to our HVC (O3000 CE readings) between July and November, 2007. HVC readers consisted of 2 advanced gastroenterology fellows and 3 attending gastroenterologists, with reading experience of 100-3,000 studies. HVC readers were blinded to indications and CG findings. Reviewed studies were presented at a weekly CE conference for group assessment and consensus. Group consensus was established blinded to CG interpretation, then compared with CG interpretation and recorded as major disagreement (resulting in a recommendation impacting the need for an endoscopic/surgical procedure or medication) minor disagreement, (disagreement that would have no clinical implication), or no disagreement. If double balloon enteroscopy (DBE) was performed, these findings were used as a gold standard for the presence of small bowel pathology. DBE were performed by one of 2 endoscopists who were usually aware of the CG interpretations. Results: 43 consecutive CE studies were reviewed. Most (65%) CE studies were referred with a request for DBE, and 35% were sent for a second opinion in interpretation. Major disagreement was found in 38.1%, and minor disagreement was noted in 31.7%; both a major and a minor disagreement were found in 3 cases (8%). DBE was performed in 27 (66%) patients, with positive findings in 17 (62.9%). DBE results were available in 8 cases with major disagreement in CE interpretation. In this subgroup the HVC accuracy was 100% as compared to 13% by CG (p Z 0.0014). False positives and false negatives were found in 3/8 (38%) and 4/8 (80%), respectively, of CG interpretations. DBE-confirmed false negatives cases included 1 adenocarcinoma, 1 sarcoma, 1 NSAID-stricture, and 1 probable lymphoma. Conclusions: CE studies sent for re-assessment from a CG to HVC are prone to misinterpretation that can impact clinical care. However, this high incidence of discrepancy may be biased by the selective nature of our referrals.

546 Correlation of CT Enterography (CTE) and Capsule Endoscopy (CE) Findings in Patients Being Evaluated for Suspected Small Bowel (SB) Disease Daniel S. Mishkin, Jaroslaw N. Tkacz, Brian C. Lucey An SBFT has been the radiographic test of choice for imaging the SB lumen despite its limitations. Using CE and CTE, we have been able to evaluate the entire SB in a non-invasive manner. Our goal is to evaluate the complementary role of CE and CTE in patients who underwent both tests. Methods: We evaluated 100 patients with suspected SB disease, referred for CE. All CE examinations were performed using the PillCam SBÒ and the CTE protocol used a 64 MDCT and neutral oral contrast, VoLumenÒ 1350mL. All CEs were booked through one gastroenterologist (DSM) who ordered a CTE on patients pre-CE, unless they recently had another similar imaging study or renal failure. Some patients were sent for CTE post-CE to further clarify visualized or suspected abnormalities, most with a prior normal SBFT. Results: A total of 100 patients underwent both CE and CTE; 88 patients had a CTE pre-CE and 12 had a CTE post-CE (table 1).In the pre-CE group, the most common indications include GIB and IDA, with the most common etiology being vascular ectasias only visualized on CE. Only 6 such patients had positive CTE findings of small bowel tumors and extraintestinal lesions, as most patients with a positive CTE pre-CE never underwent a CE. Patient with known or suspected CD had a strong concordance of findings (12/16). In 6 of the 12 patients with post-CE

Volume 67, No. 5 : 2008 GASTROINTESTINAL ENDOSCOPY AB91