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

NCT ID: NCT02921399

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 149 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-10
• Study Completion Date: 2021-06-30

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.

Conditions

H.Pylori Eradication Rate

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

eradication timing

Intervention Type: 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.

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).

eradication timing

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gangnam Severance Hospital

OTHER

Sponsor Role: lead

Responsible Party

Young Hoon Youn

Department of Internal Medicine,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gangnam Severance Hospital, Yonsei Unversity

Seoul, , South Korea

Countries

South Korea

References

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 May 28. doi: 10.5009/gnl250004. Online ahead of print.

Reference Type: DERIVED

PMID: 40425226 (View on PubMed)

Other Identifiers

3-2016-0175

Identifier Type: -

Identifier Source: org_study_id