Ji Min Choi1, Sang Gyun Kim2, Jeongmin Choi3, Jae Yong Park2, Sooyeon Oh2, Hyo-Joon Yang4, Joo Hyun Lim1, Jong Pil Im2, Joo Sung Kim2, Hyun Chae Jung2. 1. Department of Internal Medicine, Healthcare Research Institute, Seoul National University Hospital Healthcare System Gangnam Center, Seoul, Korea. 2. Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea. 3. Department of Internal Medicine, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea. 4. Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
Abstract
BACKGROUND AND AIMS: Whether eradication of Helicobacter pylori reduces the incidence of metachronous gastric cancer (MGC) is still debatable. We aimed to evaluate the long-term effect of H pylori eradication on the development of MGC after endoscopic gastric tumor resection. METHODS: We undertook an open-label, prospective, randomized controlled trial at a tertiary hospital in Seoul, Korea. Participants were recruited during April 2005 to February 2011 and followed until December 2016. We assigned 898 patients with H pylori infection treated withendoscopic resection (ER) for gastric dysplasia or early gastric cancer to receive (n =442) or not receive (n =456) eradication therapy using a random-number chart. Eradication group patients received oral omeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg twice daily for a week, whereas control group patients received no H pylori treatment. The primary outcome was the incidence of MGC (intention-to-treat analysis). RESULTS: The 877 patients who attended ≥1 follow-up examination (eradication group, 437; control group, 440) were analyzed. Median follow-up was 71.6 months (interquartile range, 42.1-90.0). MGC developed in 18 (4.1%) eradication and 36 (8.2%) control group patients (log-rank test, P = .01). In our yearly analysis, the effect of eradication showed a significant difference in 5 years after allocation (log-rank test, P = .02). The adjusted hazard ratio for the control group was 2.02 (95% CI, 1.14-3.56; P = .02), compared with the eradication group. CONCLUSIONS: H pylori eradication significantly reduces the incidence of MGC after ER of gastric tumors and should be considered for H pylori-positive gastric tumor patients treated with ER. (Clinical trial registration number: NCT01510730.).
RCT Entities:
BACKGROUND AND AIMS: Whether eradication of Helicobacter pylori reduces the incidence of metachronous gastric cancer (MGC) is still debatable. We aimed to evaluate the long-term effect of H pylori eradication on the development of MGC after endoscopic gastric tumor resection. METHODS: We undertook an open-label, prospective, randomized controlled trial at a tertiary hospital in Seoul, Korea. Participants were recruited during April 2005 to February 2011 and followed until December 2016. We assigned 898 patients with H pylori infection treated with endoscopic resection (ER) for gastric dysplasia or early gastric cancer to receive (n =442) or not receive (n =456) eradication therapy using a random-number chart. Eradication group patients received oral omeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg twice daily for a week, whereas control group patients received no H pylori treatment. The primary outcome was the incidence of MGC (intention-to-treat analysis). RESULTS: The 877 patients who attended ≥1 follow-up examination (eradication group, 437; control group, 440) were analyzed. Median follow-up was 71.6 months (interquartile range, 42.1-90.0). MGC developed in 18 (4.1%) eradication and 36 (8.2%) control group patients (log-rank test, P = .01). In our yearly analysis, the effect of eradication showed a significant difference in 5 years after allocation (log-rank test, P = .02). The adjusted hazard ratio for the control group was 2.02 (95% CI, 1.14-3.56; P = .02), compared with the eradication group. CONCLUSIONS: H pylori eradication significantly reduces the incidence of MGC after ER of gastric tumors and should be considered for H pylori-positive gastric tumorpatients treated with ER. (Clinical trial registration number: NCT01510730.).
Authors: Sebastian Rupp; Apostolis Papaefthymiou; Eleftherios Chatzimichael; Stergios A Polyzos; Stefan Spreitzer; Michael Doulberis; Thomas Kuntzen; Jannis Kountouras Journal: Ann Gastroenterol Date: 2022-06-02
Authors: Chan Hyuk Park; Dong-Hoon Yang; Jong Wook Kim; Jie-Hyun Kim; Ji Hyun Kim; Yang Won Min; Si Hyung Lee; Jung Ho Bae; Hyunsoo Chung; Kee Don Choi; Jun Chul Park; Hyuk Lee; Min-Seob Kwak; Bun Kim; Hyun Jung Lee; Hye Seung Lee; Miyoung Choi; Dong-Ah Park; Jong Yeul Lee; Jeong-Sik Byeon; Chan Guk Park; Joo Young Cho; Soo Teik Lee; Hoon Jai Chun Journal: Intest Res Date: 2020-10-13