Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to determine whether Helicobacter pylori eradication could reduce the new tumor development after endoscopic resection of gastric tumor.


Clinical Trial Description

The association between Helicobacter pylori infection and development of gastric cancer has been established by epidemiologic studies. Conversely, eradication of H. pylori showed no significant reduction of the incidence of gastric cancer in a large-scale, double-blind, randomized controlled trial. Eradication of H. pylori to prevent cancer was only effective in the subgroup without precancerous lesions (i,e, dysplasia, intestinal metaplasia, and atrophy). In contrast, randomized prospective study in Japan showed that H. pylori eradication after endoscopic resection of early gastric cancer significantly reduced metachronous gastric cancer. To solve this conflicting issue is critical because gastric cancer is the second leading cancer incidence worldwide, particularly Korea, Japan, and China have highest cancer incidence, and its incidence might decrease by H. pylori eradication treatment.

With respect to therapeutic modality, endoscopic resection for early gastric cancer is currently the established treatment of choice in Korea and Japan because it has been proven to be both minimally invasive and effective in the curative treatment of early gastric cancer.

Endoscopic resection has also been performed in the gastric dysplasia because dysplasia has to some extent malignant potential although firm evidence is lacking. In comparison with surgical resection, endoscopic resection conserves remnant stomach. Accordingly, patients treated with endoscopic resection have higher possibility for metachronous gastric cancer than those treated with surgical resection.

So far, it has not yet been clearly established whether H pylori eradication for gastric tumors (early gastric cancer and gastric dysplasia) could reduce metachronous cancer. We performed randomized controlled, open-label trial on the effect of new cancer development after H pylori eradication for gastric tumors. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01510730
Study type Interventional
Source Seoul National University Hospital
Contact
Status Completed
Phase Phase 3
Start date January 2005
Completion date February 2011

See also
  Status Clinical Trial Phase
Completed NCT02892409 - TAK-438 Bismuth Drug Interaction Study Phase 1
Completed NCT05073367 - A Study Reviewing Medical Records of Adults With Helicobacter Pylori Infections in China
Completed NCT00596401 - The Preventive Effect of Helicobacter Pylori Eradication on the Development of Gastric Cancer
Not yet recruiting NCT04101708 - A Comparison of High-dose Dual Therapy and Half-dose Clarithromycin-containing Bismuth Quadruple Therapy for H.P Eradication in Elderly Patients Phase 4
Recruiting NCT04030715 - The Associations Between the Gastric Mucosal Pathology and the Eradication Rate of H.Pylori :A Multicenter Study N/A
Recruiting NCT04029493 - The Situation of Re-infection of Helicobacter Pylori After Successful Eradication
Recruiting NCT04029415 - The Study of the Antimicrobial Resistance of Helicobacter Pylori in Shandong Province
Not yet recruiting NCT02934048 - Optimal Duration of Antimicrobial Susceptibility Test (AST) Guided Rescue Therapy for Helicobacter Pylori Infection Phase 4
Not yet recruiting NCT02933229 - The Influence of Helicobacter Pylori Eradication on Gastric Pathology: a Long-term, Prospective Cohort Study Phase 4
Recruiting NCT05184491 - Nitazoxanide and Lansoprazole Based Regimens for H. Pylori Management Phase 4
Recruiting NCT05790525 - Effect of Oral Helicobacter Pylori Infection on the Efficacy of Gastroluminal Helicobacter Pylori Eradication Therapy Phase 4
Completed NCT05790512 - Association of Oral Helicobacter Pylori Infection With Gastric Helicobacter Pylori Infection
Recruiting NCT05276557 - PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study Phase 3
Recruiting NCT03177629 - H. Pylori Eradication for Moderate ITP Phase 3
Recruiting NCT05053945 - Helicobacter Pylori, Atrophic Gastritis and Intestinal Metaplasia Registry and Prospective Study
Recruiting NCT05449028 - Helicobacter Pylori Eradication Therapy in Portugal N/A
Recruiting NCT00306280 - Feasibility Study of Phototherapy System to Treat H Pylori N/A
Active, not recruiting NCT02675010 - Value of Additional Corpus Biopsy for Diagnosis of H Pylori in Atrophic Gastritis. Prospective Non-randomized Study N/A
Withdrawn NCT00467155 - Helicobacter in The Gambia (Part 2) N/A
Completed NCT03716622 - A Comparison of Clarithromycin-based and Furazolidone-based Bismuth-containing Regimens for H. Pylori Eradication Phase 4