Effects of H. Pylori Eradication on the Gastric Preneoplastic Lesion and Neoplasm After ESD

November 7, 2023 updated by: Il Ju Choi, National Cancer Center, Korea

Effect of Helicobacter Pylori Eradication on Glandular Atrophy and Metachronous Cancer in Patients Undergoing Endoscopic Mucosal Resection for Gastric Cancer

This study evaluates whether Helicobacter pylori eradication improves precancerous lesions including glandular atrophy and intestinal metaplasia as well as metachronous cancers or dysplasias after endoscopic mucosal resection for gastric cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Helicobacter pylori is a primary etiological agent leading to chronic gastritis and peptic ulcer. The organism is also associated with gastric cancer in epidemiological studies. However detailed mechanism of carcinogenesis remains unknown. Histolopathological studies indicate that chronic H. pylori infection progresses over decades through stages of chronic gastritis, atrophy, intestinal metaplasia, dysplasia and cancer. Gastric atrophy and intestinal metaplasia are considered as precancerous lesions, but whether H. pylori eradication improves these lesions and prevents metachronous gastric cancer is controversial. And the issue has not been evaluated in gastric cancer patients. However, despite the conflicting evidences from two open labelled randomized controlled trials, current guidelines from various regions recommend H. pylori eradication treatment in patients who were treated for gastric cancer by surgically or endoscopically. Thus, it is important to evaluate whether H. pylori eradication can improve known precancerous lesion, i.e. glandular atrophy and intestinal metaplasia in gastric cancer patients. Such histological improvement can eventually reduce secondary gastric cancer development and provide evidence for current guidelines.

Study Type

Interventional

Enrollment (Actual)

470

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Goyang, Gyeonggi, Korea, Republic of, 410-769
        • National Cancer Center, Korea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Early Gastric cancer or high grade dysplasia confirmed by endoscopy

    • Histologically confirmed well or moderately differentiated adenocarcinoma, or high grade dysplasia
    • Submucosal invasion is not suspected
    • No evidence of ulceration or ulcer scar within the lesion
  • Helicobacter pylori infection was confirmed by histological evaluation and rapid urease test
  • Pre op CT stage: IA (T1N0M0) according to UICC TNM classification system
  • Informed consent should be signed

Exclusion Criteria:

  • Recurrent gastric cancer
  • Previous serious side effect to antibiotics
  • H. pylori eradication treatment history
  • Poorly differentiated adenocarcinoma or Signet ring cell carcinoma
  • Undergoing operation due to complication of EMR
  • Undergoing operation due to remnant cancer
  • Other malignancy within the past 5 years
  • Pregnant or nursing women
  • Serious concurrent infection or nonmalignant disease such as liver cirrhosis, renal failure, cardiovascular diseases
  • Psychiatric disorder that would preclude compliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 7 day H.pylori eradication
Treatment: Omeprazole 20 mg or Rabeprazole 10 mg bid + clarithromycin 500 mg and amoxicillin 1,000 mg bid for 7 days
Drug: 7 day H.pylori eradication Omeprazole or Rabeprazole, Clarithromycin, Amoxicillin
Omeprazole 20 mg or Rabeprazole 10 mg bid for 7 days, Clarithromycin 500 mg bid for 7 days, Amoxicillin 1,000 mg bid for 7 days.
Other Names:
  • 7 day Proton pump inhibitor (PPI)-based standard triple therapy
Placebo Comparator: Placebo
Omeprazole 20 mg or Rabeprazole 10 mg bid + Placebo for two antibiotics (clarithromycin and amoxicillin) bid for 7 days
Drug: Placebo, Omeprazole or Rabeprazole, Clarithromycin
Omeprazole 20 mg or Rabeprazole 10 mg bid for 7 days, Placebo for clarithromycin 500 mg bid for 7 days, Placebo for amoxicillin 1,000 mg bid for 7 days.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement (histological) of glandular atrophy
Time Frame: 3 years after enrollment
Improvement of glandular atrophy at the corpus lesser curvature
3 years after enrollment
Incidence of metachronous gastric cancer
Time Frame: 3 years after last patient enrollment
Comparison of metachronous gastric cancer according to the allocated treatment
3 years after last patient enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of new gastric dysplasia
Time Frame: 3 years after last patient enrollment
Comparison of new gastric dysplasia according to the allocated treatment
3 years after last patient enrollment
Overall survival
Time Frame: 3 years after last patient enrollment
Comparison of overall survival according to the allocated treatment
3 years after last patient enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: Il Ju Choi, MD, PhD, National Cancer Center, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2003

Primary Completion (Actual)

June 1, 2016

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

March 13, 2015

First Submitted That Met QC Criteria

April 1, 2015

First Posted (Estimated)

April 2, 2015

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCCTS03-062
  • 1310280 (Other Grant/Funding Number: National Cancer Center, Korea)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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