Efficacy Study of Helicobacter Pylori Eradication in Patients Undergoing Subtotal Gastrectomy for Gastric Cancer

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Helicobacter pylori (H. pylori) is associated with gastric cancer in epidemiological studies.Gastric atrophy and intestinal metaplasia caused by H. pylori are considered as precancerous lesions, but whether H. pylori eradication improves these lesions is controversial.The primary objective of this study is to evaluate whether Helicobacter pylori eradication improves glandular atrophy and intestinal metaplasia which are known to be precancerous condition in patients undergoing subtotal gastrectomy for gastric cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Center, Korea

Criteria

Inclusion Criteria:

• AGC or EGC confirmed by endoscopy

• Histologically confirmed adenocarcinoma of stomach

• Helicobacter pylori infection was confirmed by biopsy and CLO

• Pre op CT stage: IA, IB, II, IIIA according to UICC TNM classification system

• Pre op biopsy (body LC side) shows either intestinal metaplasia or glandular atrophy (at least grade 1)

• Tumor location is suitable for subtotal gastrectomy- i.e. at or distal to lower body

• Informed consent should be signed

Exclusion Criteria:

• Recurrent gastric cancer

• Previous serious side effect to antibiotics

• H. pylori eradication treatment history

• 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