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

Optimal Initiation of Helicobacter Pylori Eradication After Endoscopic Resection

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.

Study Overview

• Status: Completed
• Conditions: H.Pylori Eradication Rate
• Intervention / Treatment: Other: eradication timing

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 Type: Observational
• Enrollment (Actual): 149

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06273
    • Gangnam Severance Hospital, Yonsei Unversity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2016
• Primary Completion (Actual): March 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: September 29, 2016
• First Submitted That Met QC Criteria: September 30, 2016
• First Posted (Estimated): October 3, 2016

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 3-2016-0175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No