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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

470 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2030-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Helicobacter Pylori Infection Early Gastric Cancer Endoscopic Resection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

7 day H.pylori eradication Omeprazole or Rabeprazole, Clarithromycin, Amoxicillin

Intervention Type DRUG

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.

Placebo

Omeprazole 20 mg or Rabeprazole 10 mg bid + Placebo for two antibiotics (clarithromycin and amoxicillin) bid for 7 days

Group Type PLACEBO_COMPARATOR

Placebo, Omeprazole or Rabeprazole, Clarithromycin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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7 day Proton pump inhibitor (PPI)-based standard triple therapy Placebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No