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Efficacy and safety of 1-week Helicobacter pylori eradication therapy and 7-week rebamipide treatment after endoscopic submucosal dissection of early gastric cancer in comparison with 8-week PPI standard treatment: a randomized, controlled, prospective, multicenter study

Gastric Cancer, 2015, Vol.18(3), pp.612-617 [Peer Reviewed Journal]

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  • Title:
    Efficacy and safety of 1-week Helicobacter pylori eradication therapy and 7-week rebamipide treatment after endoscopic submucosal dissection of early gastric cancer in comparison with 8-week PPI standard treatment: a randomized, controlled, prospective, multicenter study
  • Author: Higuchi, Kazuhide ; Takeuchi, Toshihisa ; Uedo, Noriya ; Takeuchi, Yoji ; Naito, Yuji ; Yagi, Nobuaki ; Tominaga, Kazunari ; Machida, Hirohisa ; Tamada, Takashi ; Morita, Yoshinori ; Yazumi, Shujiro ; Yamao, Junichi ; Iguchi, Mikitaka ; Azuma, Takeshi
  • Found In: Gastric Cancer, 2015, Vol.18(3), pp.612-617 [Peer Reviewed Journal]
  • Subjects: eradication therapy ; ESD ; Rebamipide ; PPI ; Artificial ulcer
  • Language: English
  • Description: Byline: Kazuhide Higuchi (1), Toshihisa Takeuchi (1), Noriya Uedo (2), Yoji Takeuchi (2), Yuji Naito (3), Nobuaki Yagi (3), Kazunari Tominaga (4), Hirohisa Machida (4,10), Takashi Tamada (5), Yoshinori Morita (6), Shujiro Yazumi (7), Junichi Yamao (8), Mikitaka Iguchi (9), Takeshi Azuma (6) Keywords: H. pylori eradication therapy; ESD; Rebamipide; PPI; Artificial ulcer Abstract: Background Endoscopic submucosal dissection (ESD) has been developed for early gastric cancer (EGC). Helicobacter pylori eradication therapy has been reported to have a preventive effect against metachronous recurrence of EGC after ESD. However, the efficacy and safety of eradication therapy on ESD-induced ulcer healing are not clear. In a randomized control study, we compared the standard therapy (8-week proton pump inhibitor) and eradication therapy combined with subsequent treatment with 7-week rebamipide for healing ESD-induced ulcers. Methods A multicenter, randomized, open-label study was conducted. In group A, patients received 20 mg of omeprazole for 56 days. In group B, patients received 40 mg of omeprazole, 1,500 mg of amoxicillin, and 800 mg of clarithromycin for 7 days, and then 300 mg of rebamipide for 49 days. The primary end point was to evaluate the scarring ratio. Results The scarring rate in group A was significantly higher than that in group B [85.0 % (34/40) vs. 56.8 % (21/37), P = 0.011]. The scarring rate of ulcers with an area a[yen]565.5 mm.sup.2 in group A was significantly higher than that in group B [78.9 % (15/19) vs. 37.5 % (6/16), P = 0.018]. There was no significant difference between the groups in the scarring rate of smaller ulcers. No serious adverse events were observed in any of the patients in either group. Conclusion H. pylori eradication therapy and 7-week rebamipide monotherapy were not superior to PPI monotherapy, but this combination therapy for smaller sized ulcers was an optimal therapeutic option for healing. Serious adverse events were not observed in either group. Author Affiliation: (1) 2nd Department of Internal Medicine, Osaka Medical College, 2-7 Daigaku-machi, Osaka, Takatsuki, 569-8686, Japan (2) Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan (3) Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan (4) Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka, Japan (5) Department of Gastroenterology, Takatsuki Red Cross Hospital, Osaka, Takatsuki, Japan (6) Department of Internal Medicine, Division of Gastroenterology, Kobe University Graduate School of Medicine, Hyogo, Kobe, Japan (7) Digestive Disease Center, The Tazuke Kofukai Medical Research Institute, Kitano Hospital, Osaka, Japan (8) Third Department of Internal Medicine, Nara Medical University, Nara, Japan (9) Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan (10) Machida Gastroenterical Hospital, Osaka, Japan Article History: Registration Date: 16/07/2014 Received Date: 05/02/2014 Accepted Date: 13/07/2014 Online Date: 07/08/2014
  • Identifier: ISSN: 1436-3291 ; E-ISSN: 1436-3305 ; DOI: 10.1007/s10120-014-0404-9

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