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A Planned Prospective, Randomized, Placebo-Controlled Multicenter Trial Assessing the Effect of Helicobacter pylori Eradication on the Healing of Iatrogenic Ulcer after Endoscopic Resection of Gastric Neoplasm

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Authors
Kim, Sang Gyun; Song, Ho June; Choi, Il Ju; Cho, Joo Young; Keum, Bora; Lee, Yong Chan; Park, Sue K.; Jung, Hyun Chae; Park, Byung Joo; Kim, Jae Gyu; Cheon, Jae Hee; Jung, Hwoon-Yong
Issue Date
2010-12
Publisher
EDITORIAL OFFICE GUT & LIVER
Citation
GUT AND LIVER; Vol.4 4; 514-517
Keywords
Helicobacter pyloriEndoscopic resectionIatrogenic ulcerEradicationMedical Research Collaboration Center
Abstract
Background/Aims: Helicobacter pylori eradication may facilitate the healing of iatrogenic ulcer after endoscopic resection of gastric neoplasm. This study involved designing a randomized, double-blinded, placebo-controlled, multicenter trial, performed by the Korean College of Helicobacter and Upper Gastrointestinal Research and the Medical Research Collaboration Center, Seoul National University Hospital. Methods: We intend to enroll up to 232 patients H.-pylori-positive patients who have gastric adenoma or early gastric cancer after endoscopic resection. The enrolled patients are being randomly allocated to the H.-pylori-eradication-plus-proton-pump-inhibitor group or the placebo-plus-proton-pump-inhibitor group based on their histology results and the size of the resected specimen. After random allocation, the iatrogenic ulcer size and stage are evaluated at 4- and 8-week follow-ups (with a window of 7 days). The primary end point is the healing rate of the ulcer by stage, and the secondary end point is the rate of ulcer size reduction, relief rate from ulcer-related symptoms, and adverse-event rates. Results: More than 90% of the target subjects have already been enrolled into the study and are receiving ongoing periodic monitoring by the Medical Research Collaboration Center. Conclusions: Completion of the study should reveal whether H. pylori eradication can facilitate the healing of ulcer after endoscopic resection in Korea. (Gut Liver 2010;4:514-517)
ISSN
1976-2283
Language
English
URI
https://hdl.handle.net/10371/77697
DOI
https://doi.org/10.5009/gnl.2010.4.4.514
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College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
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