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

Phase 3

Active, not recruiting

• Conditions: Helicobacter Pylori Infection; Early Gastric Cancer; Endoscopic Resection
• Interventions: Drug: 7 day H.pylori eradication Omeprazole or Rabeprazole, Clarithromycin, Amoxicillin; Drug: Placebo, Omeprazole or Rabeprazole, Clarithromycin

• Registration Number: NCT02407119
• Lead Sponsor: National Cancer Center, Korea

Brief Summary

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.

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 Timeline

• Study Start: 2003-06
• Study First Submitted: 2015-03-13
• Study First Submitted QC: 2015-04-01
• Study First Posted: 2015-04-02
• Primary Completion: 2016-06
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-09
• Study Completion: 2030-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 470

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
7 day H.pylori eradication	7 day H.pylori eradication Omeprazole or Rabeprazole, Clarithromycin, Amoxicillin	Treatment: Omeprazole 20 mg or Rabeprazole 10 mg bid + clarithromycin 500 mg and amoxicillin 1,000 mg bid for 7 days
Placebo	Placebo, Omeprazole or Rabeprazole, Clarithromycin	Omeprazole 20 mg or Rabeprazole 10 mg bid + Placebo for two antibiotics (clarithromycin and amoxicillin) bid for 7 days

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of new gastric dysplasia	3 years after last patient enrollment	Comparison of new gastric dysplasia according to the allocated treatment
Overall survival	3 years after last patient enrollment	Comparison of overall survival according to the allocated treatment

Trial Locations

Locations (1)

National Cancer Center, Korea; 🇰🇷 Goyang, Gyeonggi, Korea, Republic of