Effects of Helicobacter pylori eradication for metachronous gastric cancer prevention: a randomized controlled trial

Ji Min Choi, Sang Gyun Kim, Jeongmin Choi, Jae Yong Park, Sooyeon Oh, Hyo Joon Yang, Joo Hyun Lim, Jong Pil Im, Joo Sung Kim, Hyun Chae Jung

Research output: Contribution to journalArticle

11 Citations (Scopus)

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 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 tumor patients treated with ER. (Clinical trial registration number: NCT01510730.)

Original languageEnglish
Pages (from-to)475-485.e2
JournalGastrointestinal Endoscopy
Volume88
Issue number3
DOIs
StatePublished - Sep 2018

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Helicobacter pylori
Stomach Neoplasms
Randomized Controlled Trials
Pylorus
Stomach
Control Groups
Incidence
Safety Management
Neoplasms
Intention to Treat Analysis
Clarithromycin
Omeprazole
Amoxicillin
Korea
Tertiary Care Centers
Clinical Trials
Therapeutics
Infection

Cite this

@article{e375452d2c9f4fd4ac5e9bf7854b53bd,
title = "Effects of Helicobacter pylori eradication for metachronous gastric cancer prevention: a randomized controlled trial",
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 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 tumor patients treated with ER. (Clinical trial registration number: NCT01510730.)",
author = "Choi, {Ji Min} and Kim, {Sang Gyun} and Jeongmin Choi and Park, {Jae Yong} and Sooyeon Oh and Yang, {Hyo Joon} and Lim, {Joo Hyun} and Im, {Jong Pil} and Kim, {Joo Sung} and Jung, {Hyun Chae}",
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Effects of Helicobacter pylori eradication for metachronous gastric cancer prevention : a randomized controlled trial. / Choi, Ji Min; Kim, Sang Gyun; Choi, Jeongmin; Park, Jae Yong; Oh, Sooyeon; Yang, Hyo Joon; Lim, Joo Hyun; Im, Jong Pil; Kim, Joo Sung; Jung, Hyun Chae.

In: Gastrointestinal Endoscopy, Vol. 88, No. 3, 09.2018, p. 475-485.e2.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Effects of Helicobacter pylori eradication for metachronous gastric cancer prevention

T2 - a randomized controlled trial

AU - Choi, Ji Min

AU - Kim, Sang Gyun

AU - Choi, Jeongmin

AU - Park, Jae Yong

AU - Oh, Sooyeon

AU - Yang, Hyo Joon

AU - Lim, Joo Hyun

AU - Im, Jong Pil

AU - Kim, Joo Sung

AU - Jung, Hyun Chae

PY - 2018/9

Y1 - 2018/9

N2 - 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 tumor patients treated with ER. (Clinical trial registration number: NCT01510730.)

AB - 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 tumor patients treated with ER. (Clinical trial registration number: NCT01510730.)

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DO - 10.1016/j.gie.2018.05.009

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