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OpenTrials
Active, Not Recruiting

NCT Number: NCT02407119

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Helicobacter Pylori Infection Atrophy Digestive System Diseases Digestive System Neoplasms Early Gastric Cancer Endoscopic Resection Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Stomach Diseases Stomach Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Other names: 7 day Proton pump inhibitor (PPI)-based standard triple therapy

Placebo, Omeprazole or Rabeprazole, Clarithromycin

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.

Other names: Placebo

Primary outcomes

  1. Improvement (histological) of glandular atrophy

    Time frame: 3 years after enrollment

    Improvement of glandular atrophy at the corpus lesser curvature

  2. Incidence of metachronous gastric cancer

    Time frame: 3 years after last patient enrollment

    Comparison of metachronous gastric cancer according to the allocated treatment

Secondary outcomes

  1. Incidence of new gastric dysplasia

    Time frame: 3 years after last patient enrollment

    Comparison of new gastric dysplasia according to the allocated treatment

  2. Overall survival

    Time frame: 3 years after last patient enrollment

    Comparison of overall survival according to the allocated treatment

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2016
Study completion
2030
First posted
Apr 2, 2015
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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