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 ulcerafter endoscopic resection in Korea.
RCT Entities:
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 patientsH.-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.
Entities:
Keywords:
Endoscopic resection; Eradication; Helicobacter pylori; Iatrogenic ulcer; Medical Research Collaboration Center
Authors: K Adachi; H Suetsugu; N Moriyama; H Kazumori; A Kawamura; H Fujishiro; H Sato; T Okuyama; S Ishihara; M Watanabe; Y Kinoshita Journal: J Gastroenterol Hepatol Date: 2001-11 Impact factor: 4.029
Authors: N Uemura; S Okamoto; S Yamamoto; N Matsumura; S Yamaguchi; M Yamakido; K Taniyama; N Sasaki; R J Schlemper Journal: N Engl J Med Date: 2001-09-13 Impact factor: 91.245
Authors: Y Yamaguchi; N Katsumi; M Tauchi; M Toki; K Nakamura; K Aoki; Y Morita; M Miura; K Morozumi; H Ishida; S Takahashi Journal: Aliment Pharmacol Ther Date: 2005-06 Impact factor: 8.171
Authors: Perttu E T Arkkila; Kari Seppälä; Timo U Kosunen; Reijo Haapiainen; Eero Kivilaakso; Pentti Sipponen; Judit Mäkinen; Hannu Nuutinen; Hilpi Rautelin; Martti A Färkkilä Journal: Am J Gastroenterol Date: 2003-10 Impact factor: 10.864