Mo1534 Submucosal Endoscopy With Full-Thickness Resection (Seftr): New Endoscopic Full-Thickness Resection Technique Without Laparoscopic Assistance: a Pilot Study in the Porcine Stomach

Mo1534 Submucosal Endoscopy With Full-Thickness Resection (Seftr): New Endoscopic Full-Thickness Resection Technique Without Laparoscopic Assistance: a Pilot Study in the Porcine Stomach

Abstracts Mo1532 Fluorescein Assisted Confocal LASER Microscopy Imaging of the Mucscularis Propria in Porcine Models Masakuni Kobayashi*1,2, Kazuki S...

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Abstracts

Mo1532 Fluorescein Assisted Confocal LASER Microscopy Imaging of the Mucscularis Propria in Porcine Models Masakuni Kobayashi*1,2, Kazuki Sumiyama1, Hiroaki Matsui2, Shunsuke Kamba2, Hisao Tajiri1,2, Tsuyoshi Takahashi3,4, Kiyokazu Nakajima3,4 1 Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan; 2Division of Gastroenterology & Hepatology, The Jikei University School of Medicine, Tokyo, Japan; 3Department of Surgery, Osaka University, Osaka, Japan; 4Division of Collaborative Research for Next Generation Endoscopic Intervention, Osaka University, Osaka, Japan Background: In preceding animal studies, we have revealed that the muscularis anatomical structures of the gut wall including neural components could be histologically analyzed in in vivo by utilizing confocal laser endomicroscopy (CLE) within an artificially created submucosal space following topical application of fluorescent neuronal stains. However, in clinical settings, fluorescein is a sole readily accessible fluorescent for the CLE imaging thus far, but the muscularis visualization with fluorescein has yet to be investigated. Objective: To evaluate the feasibility of CLE visualization of the anatomical structures within the muscularis propria with the intravenous administration of fluorescein in in vivo porcine models. Method: A miniature probe type CLE system with 60mm focal depth was used in this study (Ultra Mini O, Cellvizio; MaunaKea Technologies, Paris, France). Two approximately 30kg pigs were studied under general anesthesia. A 10 mm long submucosal tunnel was made with ESD knives in the greater and lesser curvatures in the corpus and antrum of the stomach for the first pig. After intravenous administration of fluorescein, CLE observation of the muscularis propria was performed by gently applying the tip of the CLE probe inserted via a working channel of a gastroscope onto the exposed muscularis within the tunnel. For the other pig, a 20mm-ESD ulceration was made in the antrum of the stomach. A laparotomy was then performed to access to the ulcer floor from the serosal side. The CLE observation of the ESD ulcer floor was performed from both lumenal and serosal sides following intravenous administration of fluorescein. A one-minute CLE clip was recorded every five min up to 30 min after the injection of fluorescein, and the visibility of the muscularis was evaluated. Results: The muscle layer was clearly visualized in all attempts (3/3) from the submucosal tunnel for the first pig, but only from the serosal side for the second pig. The residual submucosal tissues on the ESD ulcer hindered the CLE visualization of the muscularis. The fluorescein was not well-absorbed into the muscular tissues, but the leakage of the stain into the connective tissues in the muscularis propria distinctly silhouetted the intricately running smooth muscle fibers. The muscularis could be clearly identified after 5 min for the lesser curve and about 15 min for the other sites from the fluorescein administration. Conclusion: The intravenous fluorescein administration enabled the muscularis propria to be visualized in vivo with CLE. The smooth muscle fiber was clearly delineated by the dense leakage of fluorescein into the connective tissues. The time for the visualization of the muscle layer varied depending on the anatomical location. The direct contact of the CLE probe on the muscularis surface is mandatory to clearly visualize the muscularis.

Mo1533 Computer Aided Diagnosis Using Narrow Band Imaging (NBI) - a Novel Objective Tool for Differentiating Tubular Adenoma and Hyperplastic Colon Polyps Raymond E. Kim*1, Neil Gupta2, Prashanth Vennalaganti3, Alessandro Repici4, Sravanthi Parasa5,3, Nalini M. Guda6, Prateek Sharma3,5 1 Gastroenterology and Hepatology, George Washington University, Wasington, DC; 2Division of Gastroenterology, Loyola University, Chicago, IL; 3Gastroenterology and Hepatology, VA Medical Center, Kansas City, KS; 4Digestive Endoscopy Unit, IRCCS Istituto Clinico Humanitas, Milan, Italy; 5Gastroenterology and Hepatology, University of Kansas Medical Center, Kansas City, KS; 6Gastroenterology, Aurora Health Care, Milwaukee, WI Background: NBI has been widely evaluated in patients with colon polyps and pit patterns have been observed that can differentiate tubular adenomas from hyperplastic colon polyps. However, its diagnostic value has been challenged since it relies on the observer’s subjective judgment and experience. Computer aided diagnosis using digital image analysis may provide objective data to improve diagnostic accuracy and consistency. Aim: To determine image analysis parameters that can assist in the objective differentiation of tubular adenomas from hyperplastic colon polyps. Methods: NBI images of colon polyps (both tubular adenomas and hyperplastic polyps) were obtained from a prospectively maintained colon database. Multiple parameters were used to analyze each group of images including: 1) mean color RGB value (intensity) 2) relative distribution of region intensity between the center and the margin (margination; algorithm by Ian T. Young, Pattern Recognition Group Delft University, Technology Department of Applied Physics, Netherlands) and 3) percentage of the pixels in the object that are more than 10% of the dynamic range away from the mean intensity for that object (heterogeneity). This was done using Image Pro Premier software (version 9.1; Media Cybernetics, Rockville, MD) and

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measured parameters were compared with an unpaired t-test. Results: Atotal of 41 high definition images of colon polyps (20 tubular adenomas and 21 hyperplastic polyps) were analyzed. Mean color RGB value (intensity) was significantly lower in the tubular adenoma group compare to the hyperplastic polyp group (120 vs. 135; 0255 scale, P ! 0.05). Sub RGB channel analysis revealed that the tubular adenoma group had lower blue color value (94 vs. 105, P ! 0.05) and green color value (114 vs. 141 , P ! 0.001) but no statistical difference was shown in the red color value (152 vs. 158 , P Z 0.23). The region intensity differences between the center and the margin of the image (margination) was also significantly higher in the tubular adenoma group compare to the hyperplastic polyp group (0.3401 vs. 0.3361, P !0.05). However, heterogeneity i.e. percentage of the pixels in the object that were are more thanO 10% of the dynamic range away from the mean intensity for that object was not statistically different between tubular adenoma group and hyperplastic polyp group (0.0453 vs. 0.0777, P Z 0.10). Conclusion: Our results indicate that using NBI image analysis tubular adenomas can be objectively differentiated from hyperplastic polyps opening the door to computer aided diagnosis of neoplastic lesions in the GI tract. Tubular adenomas had significantly lower intensity (mean RGB color value) and significantly higher margination (intensity difference between the center and the margin of the image) compared to hyperplastic polyps.

Parameter Mean Intensity (0-255) Blue Intensity (0-255) Green Intensity (0-255) Red Intensity (0-255) Margination Heterogeneity

Tubular adenoma

Hyperplastic polyp

P value

120 94 114 152 0.3401 0.0453

135 105 141 158 0.3361 0.0777

P ! 0.05 P ! 0.05 P ! 0.001 P Z 0.23 P ! 0.05 P Z 0.10

Mo1534 Submucosal Endoscopy With Full-Thickness Resection (Seftr): New Endoscopic Full-Thickness Resection Technique Without Laparoscopic Assistance: a Pilot Study in the Porcine Stomach Kohei Takizawa*1,2, Mary a. Knipschield1, Christopher J. Gostout1 1 Division of Gastroenterology and Hepatology, Mayo clinic, Rochester, MN; 2Division of Endoscopy, Shizuoka Cancer Center, Nagaizumi-cho, Japan Background and Aim: Endoscopic full-thickness resection (EFTR) may replace ESD and surgery for foregut subepithelial tumors and some gastrointestinal cancers. Several animal studies have reported about EFTR, however most of all needed a laparoscopic assistance. We have developed a new technique, submucosal endoscopy with full-thickness resection (SEFTR), which combines the mucosal safety valve flap (SEMF) method with EFTR. SEFTR may eliminate laparoscopic assistance. Our aim was to evaluate the feasibility and safety of SEFTR in an animal model. Methods: Five domestic pigs, median weight 46 kg, were used. Procedures were performed under general anesthesia. The study was approved by the Institutional Animal Care and Use Committee. The procedure involved four steps: 1) Circumferential mucosal incision, 2) submucosal tunnels and connections, 3) looping, lifting and cinching, and 4) full-thickness resection. 1) A 2cm area of gastric mucosa was marked by circumferential spot coagulation then submucosal injection followed by a circumferential mucosal incision (IT knife-2), 5mm outside the coagulation marks. 2) Two parallel submucosal tunnels, opposite and outside the target lesion were made using blunt tipped 11.5 mm stone extraction balloons. The oral and anal ends of each tunnel mucosa were cut to allow encircling access. 3) Suture was passed through the tunnels to encircle the lesion. Suture joined T-bars were placed full thickness into the isolated lesion. A second suture was placed through the T-bar suture loop and brought out the mouth. The suture surrounding the targeted area was cinched, drawing the lesion together into a full-thickness purse string, then cinched using an endoscopic suture cinching device. The lesion was raised (full-thickness) by pulling the oral suture. 4) A full-thickness needle knife incision was performed. Complete

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procedure rates, procedure times, complications and difficulty scales (DS) were recorded prospectively. DS were rated using a visual analog scale ranging from 0 (easy) to 5 (failed). Results: 1) Circumferential mucosal incisions were completed in all [median 6 minutes (3-14) and median 0 DS (0-1)]. 2) Submucosal tunnels and connections were completed in all [median 60 minutes (46-63) and median 2 DS (14)]. 3) In the first case, looping of the target lesion failed. In the remaining 4 cases, looping, cinching and lifting were completed [median 3 DS (2-5)]. 4) Full-thickness resections were completed in three of four [median 4 DS (1-5)]. One resection failed halfway, due to loose cinching and a displaced cinching loop. There were no procedural adverse events. All pigs survived. At necropsy, there was no damage to adjacent organs or structures. Conclusions: This experience suggests SEFTR is feasible and safe. The procedure would benefit from further development.

Mo1535 Do New Generation Narrow Band Imaging Colonoscopes Improve the Prediction of Histology for Diminutive Polyps? Preliminary Results of an Observational Prospective Study Silvia Paggi*, Arnaldo Amato, Emanuele Rondonotti, Giancarlo Spinzi, Franco Radaelli Gastroenterology, Valduce Hospital, Como, Italy Background and aim: Several studies have shown that narrow band imaging (NBI) can real-time predict polyp histology with adequate accuracy, moderate interobserver and substantial intraobserver agreement. Recently, new generation NBI colonoscopes with dual focus imaging technology have been marketed. Present study is aimed at evaluating whether this new technology may add some benefits in the real-time prediction of polyp histology. Methods: Consecutive outpatients were randomly allocated to undergo colonoscopy by standard NBI colonscopes (Olympus CF-HQ 180 series) (Group A) or new generation NBI colonoscopes (Olympus CFHQ 190 series) (Group B). Four endoscopists, expert in NBI use, were involved in the study. They were asked to high confidently categorize each polyp !6 mm as adenoma or non-adenoma according to NBI simplified criteria. Polyps categorized with low-confidence were excluded from the analysis. In Group B, the evaluation was systematically performed by applying dual focus imaging. Polyps were sent to pathology, which represented the reference standard. Results: From August to November 2013, 320 diminutive polyps were detected in 206 patients and categorized with high-confidence by the endoscopist. Histology was adenomatous in 218 polyps (68.1%); of them, features of advanced histology (high-grade dysplasia or villous component) were found in 8 cases (3.7%). Overall, 186 and 134 polyps were evaluated in Group A and Group B, respectively. In the Group A, Sensitivity, specificity, positive and negative likelihood ratios for adenoma were 89.7%, 77.9%, 0.13 and 4.1, respectively. Corresponding features for Group B were 96.7%, 83.7%, 0.04 and 5.3, respectively. A trend towards statistically significant difference between Group A and Group B was observed either for sensitivity (pZ0.05) or overall accuracy for the diagnosis of adenoma (92.5% versus 87%, pZ0.07). Conclusions: Preliminary results of present study seem to suggest that the use of new generation NBI colonscopes might improve histology prediction for diminutive polyps

Mo1536 Novel Endoscopic System With Narrow Band Imaging and Dual Focus Magnification in Detection and Characterization of Gastric Lesions Sergey V. Kashin*1, Roman Kuvaev1, Igor O. Ivanikov2, Ekaterina Tarasova1, Alexander S. Nadezhin3, Yulia Manturova3 1 Endoscopy, Yaroslavl Regional Cancer Hospital, Yaroslavl, Russian Federation; 2Gastroenterology, Central Clinical Hospital of the Business Administration for the President of Russian Federation, Moscow, Russian Federation; 3Pathology, Yaroslavl Regional Cancer Hospital, Yaroslavl, Russian Federation Background: Current standards of endoscopic diagnosis of early gastric cancer have evolved to include new advanced endoscopic techniques that enhance visualization of gastric mucosa. Newly developed endoscopic system with new generation of narrow band imaging and dual focus magnification might be a promising tool for both detection and characterization of gastric lesions. However there is no evidence to prove the clinical usefulness of this novel system for diagnosing gastric pathology. Aims&Methods: The aim of this study was to evaluate diagnostic effectiveness of novel endoscopic system in detection and characterization of gastric lesion. This study comprised 93 lesions in 43 patients (mean age 68 years). Initially all patients were investigated withwhite light endoscopy followed by NBI observation (Olympus Exera III GIF H190). Afterwards chromoendoscopy (CE) with indigocarmine was performed as the "gold standard" for detection of lesions. Finally all detected lesions were examined by NBI with dual focus magnification. Irregular microvascular pattern with irregular or absence microstructure pattern was used as the criterion of neoplasia. Biopsies were taken from all lesions for histological assessment. Results: From 93 gastric lesions there were 75 non-neoplastic (chronic gastritis, intestinal metaplasia, hyperplasic polyps), 3 low grade dysplasia, and 15 high grade dysplasia/ early gastric cancer. All lesions (100%) detected by CE were found with NBI obser-

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vation. Endoscopic histology prediction was successful in 88 cases (94,6%) Endoscopic misdiagnosis was found in 5 cases (5,4%): overestimation - in 3 cases, underestimation - in 2 cases. Sensitivity, specificity, positive predictive value and negative predictive value were 80%, 97.4%, 85.7% and 96.2% respectively for early gastric cancer/high grade dysplasia. Conclusion: Observation of gastric mucosa with a new generation of narrow band imaging endoscopy can be at least as effective as CE with indigocarmine in detection of suspicious lesions. Dual focus magnification provides sufficient assessment of microvascular and microsurface patterns in order to differentiate gastric lesions. Further randomized controlled studies are needed to be performed for clarifying the role of novel endoscopic system in diagnosis of gastric pathology.

Mo1537 Routine Confocal Endomicroscopy in a Clinic Specialized in the Management of the Digestive Pathology With Mucosectomy, Submucosal Dissection, Prosthesis and Puncture: Results of the 5 First Months of Use Jean-Marc Canard* Clinique Trocadéro, Paris, France Introduction: Probe-based Confocal Laser Endomicroscopy (pCLE) is an imaging technique that allows the achievement of an extemporaneous microscopic exam of a lesion before the treatment or to control the quality of the endoscopic treatment. The aim of the study is to appreciate the real indication of Cellvizio in routine in a clinic specialized in the management of the digestive pathology. Method: In 5 months of practice (from May, 16th until November, 23th 2013) during 436 endoscopies, 51 procedures of pCLE were performed. In all cases, the pathologist exam comforts the conclusions of the probe-based microscopic exam. Among these 51 procedures, 6 are presented:- One in the esophagus showing the utility of pCLE to find a dysplasia area on a Barrett’s Esophagus before mucosectomy followed by a BARRX destruction.- One in the colon showing the utility of pCLE to differentiate serrated polyps from hyperplasic polyps so as to realize an immediate resection.One in the stomach showing the utility of pCLE to find a gastric dysplasia area inside relief abnormalities and treat it by submucosa dissection.- One in the duodenum showing the utility of pCLE to differentiate an inflammatory granuloma from an adenomatous residue which would justify an ARGON treatment and/or a mucosectomy on a duodenal scare or a right colic that could initiate major complications.One in the biliary duct showing the utility of pCLE for the immediate diagnosis of cholangiocarcinoma (1) allowing to choose the most appropriate prosthesis.- One in the pancreas showing the utility of pCLE for the differential diagnosis of pancreas cysts (serous, mucinous, pseudocysts, cystic forms of neuroendocrine tumors). Results: For the 51first procedures the repartition was: 2 cases in the esophagus (4%), 3 in the cardia (6%), 3 in the stomach (6 %), 2 in the duodenum (4%), 1 in the small bowel (2%), 3 in the biliary duct (6%), 3 in the Vater papillia (6%) , 1 in the pancreas and 33 in the colon (64%). In 43 cases (84%), the pCLE diagnosis was consistent with those of the pathologist. In 6 cases (12% of cases, 1 in cardia BE, 1 in the stomach, 1 in colonic mucosectomy scares, 1 at the Vater papillia and 2 colonic polyps). pCLE over evaluated the lesion. In 2 cases (4% of cases, 2 cases with colon polyp), pCLE didn’t concur with the diagnosis of the pathologist. Conclusion: Optical Biopsies have been useful in the management of the lesions in the whole digestive tract in 51 cases out of 436 (11,7 % of cases) before E. M. R, E. S. D., installation of biliary prosthesis, pancreatic cysts treatment and to control the nature of potential residues on an E. M. R or E. S. D. scares.(1) M. Giovannini et al., Emid Study: Final Results of a Prospective Bicentric Study Assessing Probe-Based Confocal Laser Endomicroscopy (pCLE). Impact in the Management of Biliary Strictures, Gastrointestinal Endoscopy, May 2013

Mo1538 a Novel Endoscopic Tapered-Tip CAP Significantly Reduces Time for Endoscopic Submucosal Tunneling Hiroyuki Aihara*, Nitin Kumar, Michele B. Ryan, Marvin Ryou, Christopher C. Thompson Division of Gastroenterology, Brigham & Women’s Hospital, Boston, MA Background: Endoscopic submucosal tunneling (EST) was originally developed for natural orifice translumenal endoscopic surgery (NOTES) to facilitate creation of a safe gastrostomy, and has since been adapted for endoscopic myotomy and submucosal tumor resection. A unique endoscopic cap has been developed with a tapered tip to potentially facilitate EST. Aim: To assess the efficacy of an endoscopic transparent tapered-tip cap (ST hood) (Fig. 1) for EST in an ex-vivo model. Methods: A resected porcine colon model was used in this study. First, the colon tissue was fully inverted to expose the mucosa. As a starting landmark for EST, 15 mm transverse marking dots were made. As a destination landmark, a full-thickness knot was made with 3-0 silk suture at a point 50mm longitudinally distal to the marking dots. The tissue was then everted and fixed on an experimental platform. EST was performed using the ST hood (nZ8) versus a regular cylindrical hood (i.e. controls, nZ8). Each type of hood was used for both entry into the submucosal space and for submucosal tunneling. An endoscopic submucosal dissection knife with a water jet function was used for all procedures. Procedure time was recorded and

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