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KMID : 1188320100040040514
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Gut and Liver
2010 Volume.4 No. 4 p.514 ~ p.517
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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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Kim Sang-Gyun
Song Ho-June
Choi Il-Ju
Cho Joo-Young
Jung Hwoon-Yong
Keum Bo-Ra
Cheon Jae-Hee
Lee Yong-Chan
Kim Jae-Gyu
Park Sue-K.
Park Byung-Joo
Jung Hyun-Chae
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Abstract
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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.
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KEYWORD
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Helicobacter pylori, Iatrogenic ulcer, Endoscopic resection, Eradication, Medical Research Collaboration Center
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