Lower esophageal sphincter (les) augmentation therapy for GERD with enteryx™, a biocompatible inert polymer. Initial multicenter human trial results

*3452 A NEW INJECTABLE CYANOACRYLATE FOR THE ENDOSCOPIC OBLITERATION OF ESOPHAGOGASTRIC BLEEDING VARICES. FIRST RESULTS OF A PROSPECTIVE STUDY. Alessandro Repici, Simona Paganin, Claudio Barletti, Claudio De Angelis, Stefania Caronna, Alessandro Musso, Wilma Debernardi, Mario Rizzetto, Dept of Gastroenterology, Molinette Hosp, Torino Italy; Giorgio Saracco, Dept of Gastroenterology, Torino Italy BACKGROUND AND AIMS: The N-Butyl-2-cyanoacrylate (Histoacryl glue, Braun, Melsulgen Germany) was the glue traditionally used to control bleeding from esofagogastric (EG) varices. Since 1998 a new, chemical[y different, cyanoaerylate (N-Butil-cyanoacrylate+ metacrylossisulfan, Glubran 2, GEM, Italy) has been approved in Europe for intravariceal injection. This study aims to asses the technical feasibility, the efficacy and the safety of this new glue in the management of bleeding varices. PATIENTS AND METHODS: since November 1998, 33 consecutive pts(12 F and 21 M, mean age 49.9, range 10 - 85, 15 Child C, 9 B, 6 A, 3 non cirrhotic pts) admitted to the emergency room with first EG variceal bleeding, were prospectively enrolled into the study. Following initial clinical evaluation all pts underwent emergency endoscopy using a large channel endoscope within 6 hours from hospital admittance.Inclusion criteria were as follow: 1)active bleeding and]or 2)stigmata of recent bleeding on to EG varices. Exclusion criteria was the concomitant presence of a non variceal source of bleeding. The glue (pure, without Lipiodol)was injected using the same technique described by Soehendra for Histoacryl to achieve intravariceal obliteration. 14 pts bled from esophageal varices, 6 from junctional varices, 7 from fundal varices, 5 from esophageal and junctional varices and 1 from esophageal and fundal varices. Single injection of the glue was performed in 16 pts while 17 pts required 2 or more injection, 6 of them in different varices. The amount of injected glue ranged from 0,5 to 6 ml. Treatment failure was defined as failure to control bleeding or recurrent bleeding within 7 days from the index treatment. RESULTS: the injection of the Glubran 2 was successfully carried out in all pts. Bleeding was immediately controlled in 32/33 pts, 1 pt died for ongoing bleeding. Early rebleeding (within 7 days} occured in 5 pts requiring sclerotherapy; 2 of them died for persisting bleeding. 6 pts died within 30 days from treatment for causes unrelated to the bleeding. No scopes damages were recorded. After glue injection we observed a single local complication (intramural esophageal hematoma). CONCLUSIONS: In our preliminary experience the new Ghibran glue injection seems a safe and effective methods to control variceal bleeding with risults at least comparable with those obtained with Histoacry]. *3453 U S E F U L N E S S OF MAGNIFYING ENDOSCOPY AND NEW T E C H N I Q U E S F O R DIAGNOSIS OF PROTRUDED EARLY GASTRIC CANCER. Yoshimi Yamaguchi, Hiroshi Takahashi, Kunio Ukawa, Tatsuhiro Shoji, Rikiya Fujita, Showa Univ Fujigaoka Hosp, Yokohama Japan BACKGROUND: This is difficult to discriminate early gastric cancer from gastric adenoma, since only a part of the lesion can be diagnosed by tissue biopsy. To solve this problem, we developed new techniques for magnifying endoscopy and verified those efficacies as tools of"optical biopsy." METHODS: New magnifying endoscopy, GIFT,~EQ240Z (Olympus corp., Tokyo), has zoom images up to 80 times magnification. We used a short plastic attachment placed at the tip of the endoscope. "Water filling technique" was also used. In conjunction with the endoscope attachment, we can hold water in front of the lens and can keep the proper distance from the lesion. We performed chromoscopy using crystal violet (0.02-0.1%) as well. Total of 25 patients who had elevated fiat lesion in the stomach were examined. After these examinations, endoscopic mucosal resection (EMR) was performed for all the lesions. According to the standard of Hirota, we classified the degree of the histopathological atypia of adenomas into Grade I, II and III. This classification includes cellular atypia (C1 mild C3 severe) and gland structure atypia (S1 mild $3 severe). We compared the endoscopic morphological findings and pathological diagnosis of each lesion. RESULTS: Of these subjects, 11 lesions were diagnosed as gastric adenoma and 14 lesions were diagnosed as focal cancer in adenoma or early cancer by pathology after EMR. We classified the surface patterns of protruded gastric lesions observed by magnifying endoscope into 6 groups: dot, sulciolar, reticular, irregular destructive and abnormal vessel patterns. We found dot and/or sulciolar patterns in Grade I and Grade II adenoma. However, we observed reticular, irregular, destructive and abnormal vessel patterns in Grade III adenoma and cancer. Few lesions showed only dot and/or sulciolar patterns but were diagnosed as Grade III adenoma. CONCLUSION: The inherent difficulties of magnifying endoscopy were blur image, light reflexion and difficulty of fixation of the objective field. We solve these problems using new devices and techniques. Both dot and sulciolar patterns are considered as benign findings. The rest 4 patterns are regarded as signs of gland structure atypia. Thus, magnifying endoscopy is very useful for the evaluation of protruded lesions of the stomach.

VOLUME 53, NO. 5, 2001

*3454 THE APPLICATION OF MAGNIFYING ENDOSCOPY TO GASTRIC CANCER DIAGNOSIS: A PROSPECTIVE STUDY Hisao Tajiri, Toshihiko Doi, Hisashi Endo, Tomohiro Nishina, Takashi Terao, Shoji Hirasaki, Ichinosuke Hyodo, National Shikoku Cancer Ctr Hosp, Matsuyama Japan; Kazuyoshi Yagi, Niigata Prefectural Hosp, Niigata Japan Backgrounds and Aims: It has been reported that the fine mucosal patterns consisting of gastric crypts can be observed by a magnifying view and it may be helpful to make preliminary evaluations prior to the histological diagnosis. The aim of this study was to clarify the relationship between the fine mucosal patterns of gastric lesions and the histological findings and to evaluate the usefulness of magnifying endoscopy. Materials and Methods: Gastrointestinal endoscopy using a magnifying endoscope (GIF-Q240Z, Olympus Co., Japan) was performed on 306 patients between January 2000 and November 2000 at the National Shikoku Cancer Center. GIFQ240Z, a recently developed magnifying video endoscope enables us to obtain findings at the magnification of up to 80 times. In total, 211 lesions, including 80 early gastric cancer lesions (28 for elevated type, 52 for depressed type), 8 advanced cancer lesions and 12 adenomas, were detected. These magnifying endoscopic findings were compared with the histological findings. Results: Coarse and irregular mucosal patterns were observed for elevated type cancer by magnifying endoscopy. In depressed type cancer, the finer crypt pattern than that of the surrounding mucosa, destruction or disappearance of the mucosal microstructure and abnormal capillary vessels were seen by magnifying endoscopy. These results were closely related to the mucosal microstructures on the dissecting microscopy and the histological features. Out of 111 lesions diagnosed as benign such as polyp, ulcer and erosion by magnifying endoscopy, 106 (96%) were confirmed as benign on histology. The number of lesions endoscopically diagnosed as neoplastic was 101, and 96 (95%) of them were confirmed as cancer or adenoma on histology. The sensitivity and specificity as a diagnostic method of magnifying endoscopy used in this study are 96% and 96%, respectively. Conclusions: The fine mucosal patterns and the features of capillary vessels in gastric lesions obtained by magnifying endoscopy were correlated well with the histological findings. Magnifying endoscopy will be very useful in predicting the histological diagnosis during routine endoscopic procedures.

*3455 LOWER ESOPHAGEAL S P H I N C T E R (LES) AUGMENTATION THERAPY FOR GERD WITH ENTERYX"~t, A BIOCOMPATIBLE INERT POLYMER. INITIAL MULTICENTER HUMAN TRIAL RESULTS. Glen A. Lehman, Indiana Univ Medical Ctr, Indianapolis, IN; Jacques Deviere, ULB - Hosp Erasme, Brussels Belgium; Gregory Haber, Univ of Toronto, Toronto Canada; Karen Hieston, Indiana Univ Medical Ctr, Indianapolis, IN; Hubert Louis, ULB - Hosp Erasme, Brussels Belgium; Maria Cirocce, Univ of Toronto, Toronto Canada; David E. Silverman, Jill Visor, Enteric Medical Technologies, Foster City, CA; Jeffrey H. Peters, Univ of Southern CA, Los Angeles, CA; Robert Ganz, Minnesota Gastroenterology, Minneapolis, MN Background: Endoscopic methods to improve LES competence continue to be evaluated. Preliminary data from 15 pilot patients from Europe showed that implantation of 2-6 ml of ethylene-vinyl-alcohol (EVOH, EnteryxTM) at the LES improved GERD parameters in 13/15 PPI dependent GERD patients. A multicenter European/North American protocol was then initiated. Inclusion criteria include: 1) GERD symptoms controlled with PPI, 2) 24 hour pH with > 5% time with pH <4, 3) Velanovich GERD score < 11 on PPI and > 20 off PPI. Exclusion criteria include: 1) Erosive esophagitis _> grade 3, 2) Hiatal hernia > 3 cm; 3) Barretts esophagus; 4) Esophageal body motility disorder; 5) Varices. Methods: UGI endoscopy with sclerotherapy type needle implantation in 3-4 quadrants of 2-6 ml of EnteryxTM into the deep submucosaYmuscular levels of the LES/cardia. GERD parameters will be followed for 1 year while off PPI's. To date 17 patients have been enrolled (goal 75 patients). Results: The table shows mean GERD scores on patients with at least 1 month follow up. Complications/side effects in a portion of patients: Analgesics for chest pain for 1-7 days. Low grade fever x 1-3 days (prophylactic antibiotics given). Intraluminal slough of a portion of implant implant material. Summary: In this ongoing study, early followup shows good GERD symptom control while off PPI therapy in most patients. Conclusion: Continued enrollment and longer term followup are awaited.

n

Mean Velsnovich GERD Health Survey Score* PreimplantsfJon 1 Month Post Implantation On PPI Off PPI Off PPI

14

8

28

--p<.05--

11

"Abnormal score ~>12

GASTROINTESTINAL ENDOSCOPY

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