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Completed

NCT Number: NCT02921399

Optimal Initiation of Helicobacter Pylori Eradication After Endoscopic Resection for Gastric Neoplasm

After endoscopic resection (ER) of gastric tumors, eradication of Helicobacter pylori (H. pylori) infection is advised to reduce metachronous recurrence. However, few studies have addressed factors influencing H. pylori eradication rates in the aftermath of ER, and none have focused on the optimal timing of therapy to eradicate H. pylori post-ER.Therefore, the investigators will conduct to evaluate whether differences in timing of eradication therapy after ER of gastric tumors.

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Key information

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gangnam Severance Hospital, Yonsei Unversity

Seoul, 06273, South Korea

About this study

Uur previous retrospective study unveiled that administering eradication treatment within 2 weeks post-ESD during the active reparative phase of ESD-induced ulcers yielded a markedly higher success rate compared to treatment post-8 weeks during the scarring phase of ESD-induced ulcers.Therefore, we conducted a multicenter, randomized, prospective study to ascertain whether the optimal timing of eradication post-ESD could influence the eradication success rate.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients underwent endoscopic resection of gastric neoplasm
  • patients who diagnosed as H. pylori infection by rapid urease test

Exclusion criteria

  • Histories of gastric surgery
  • Histories of prior H. pylori eradication therapy
  • Use of drugs affecting H. pylori positivity (proton pump inhibitor, histamine-2 receptor blocker, or antibiotics) within the preceding 2 weeks

Treatment and study plan

eradication timing

Other

patients who underwent ESD for gastric neoplasms were randomized to receive early (3-5 days) or late (8-9 weeks) H. pylori eradication therapy after ESD.

Primary outcomes

  1. H. pylori eradication rate according to timing of therapeutic regimen after endoscopic resection

    Time frame: The success of H. pylori eradication was determined using a urea breath test conducted 13 weeks ± 5 days after ESD

    The success of H. pylori eradication was determined using a urea breath test conducted

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

Optimal Initiation of Helicobacter Pylori Eradication After Endoscopic Resection

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Oct 3, 2016
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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