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

NCT02921399 | Completed DMC

• 1 other identifier: 3-2016-0175
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

H.Pylori Eradication Rate

Outcome Measures

Primary Outcomes (1)

• 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

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

Study Arms (2)

early eradication group

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).

Other: eradication timing

late eradication group

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).

Other: eradication timing

Interventions

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.

early eradication group; late eradication group

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who received proton-pump inhibitor (PPI)-based triple therapy for H. pylori eradication after endoscopic resection for gastric neoplasms. Clinicopathologic characteristics, particularly the timing of triple therapy, were used to compare eradication rates, assigning patients to early- (≤2 weeks),and late-phase (≥8 weeks) eradication groups.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

Gangnam Severance Hospital, Yonsei Unversity

Seoul, 06273, South Korea

Location

Related Publications (1)

• Huh CW, Jung DH, Kim JH, Park H, Youn YH. Early versus Late Eradication of Helicobacter pylori after Endoscopic Submucosal Dissection of Gastric Neoplasms: A Prospective, Multicenter, Randomized, Controlled Study. Gut Liver. 2025 Nov 15;19(6):821-828. doi: 10.5009/gnl250004. Epub 2025 May 28.

  PMID: 40425226 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Internal Medicine,

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: October 3, 2016
• Study Start: October 10, 2016
• Primary Completion: March 30, 2021
• Study Completion: June 30, 2021
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)