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

Completed

• Conditions: H.Pylori Eradication Rate
• Interventions: Other: eradication timing

• Registration Number: NCT02921399
• Lead Sponsor: Gangnam Severance Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-09-29
• Study First Submitted QC: 2016-09-30
• Study First Posted: 2016-10-03
• Study Start: 2016-10-10
• Primary Completion: 2021-03-30
• Study Completion: 2021-06-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
early eradication group	eradication timing	In the post-endoscopic resection period, patients were grouped by timing (i.e., initiation) of therapy to eradicate H. pylori as follows: 1) early (≤ 2 weeks), 2) late (≥ 8weeks).
late eradication group	eradication timing	In the post-endoscopic resection period, patients were grouped by timing (i.e., initiation) of therapy to eradicate H. pylori as follows: 1) early (≤ 2 weeks), 2) late (≥ 8weeks).

Primary Outcome Measures

Name	Time	Method
H. pylori eradication rate according to timing of therapeutic regimen after endoscopic resection	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

Trial Locations

Locations (1)

Gangnam Severance Hospital, Yonsei Unversity; 🇰🇷 Seoul, Korea, Republic of