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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02407119
• Other study ID #: NCCCTS03-062
• Secondary ID: 1310280
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 2003
• Est. completion date: June 2030

Study information

• Verified date: November 2023
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 470
• Est. completion date: June 2030
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Early Gastric Cancer
• Endoscopic Resection
• Helicobacter Pylori Infection
• Stomach Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center, Korea	Goyang	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement (histological) of glandular atrophy	Improvement of glandular atrophy at the corpus lesser curvature	3 years after enrollment
Primary	Incidence of metachronous gastric cancer	Comparison of metachronous gastric cancer according to the allocated treatment	3 years after last patient enrollment
Secondary	Incidence of new gastric dysplasia	Comparison of new gastric dysplasia according to the allocated treatment	3 years after last patient enrollment
Secondary	Overall survival	Comparison of overall survival according to the allocated treatment	3 years after last patient enrollment