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

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ClinicalTrials.gov Identifier: NCT02407119
Recruitment Status : Active, not recruiting
First Posted : April 2, 2015
Last Update Posted : September 18, 2017
Sponsor:
Information provided by (Responsible Party):
Il Ju Choi, 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.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Early Gastric Cancer Endoscopic Resection Drug: 7 day H.pylori eradication Omeprazole or Rabeprazole, Clarithromycin, Amoxicillin Drug: Placebo, Omeprazole or Rabeprazole, Clarithromycin Phase 3

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  (Clinical Trial)
Actual Enrollment : 470 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Helicobacter Pylori Eradication on Glandular Atrophy and Metachronous Cancer in Patients Undergoing Endoscopic Mucosal Resection for Gastric Cancer
Study Start Date : June 2003
Actual Primary Completion Date : June 2016
Estimated Study Completion Date : June 2022


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 Name: 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 Name: Placebo




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02407119


Locations
Korea, Republic of
National Cancer Center, Korea
Goyang, Gyeonggi, Korea, Republic of, 410-769
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Il Ju Choi, MD, PhD National Cancer Center, Korea

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Il Ju Choi, MD, PhD, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT02407119     History of Changes
Other Study ID Numbers: NCCCTS03-062
1310280 ( Other Grant/Funding Number: National Cancer Center, Korea )
First Posted: April 2, 2015    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Il Ju Choi, National Cancer Center, Korea:
H. pylori eradication
Atrophy
Intestinal metaplasia
Endoscopic resection
Stomach neoplasm

Additional relevant MeSH terms:
Stomach Neoplasms
Helicobacter Infections
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Clarithromycin
Omeprazole
Rabeprazole
Proton Pump Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors