Clinical Trial: Helicobacter Pylori Eradication After Endoscopic Resection of Gastric Tumors

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Helicobacter Pylori Eradication on the New Tumor Development After Endoscopic Resection of Gastric Tumors

Brief 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.

Detailed Summary:

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 t
Sponsor: Seoul National University Hospital

Current Primary Outcome: Effect of eradication of Helicobacter pylori on incidence of metachronous gastric carcinoma after endoscopic resection of gastric tumor. [ Time Frame: we set the time frame as at least three years. ]

Primary outcome is the incidence of new cancer development after endoscopic resection of gastric tumors between eradication and control groups. Previous reports showed the incidence of new cancer between two groups differs at least 3years.


Original Primary Outcome: Same as current

Current Secondary Outcome: effect of eradication of Helicobacter pylori on incidence of High grade dysplasia development after endoscopic resection of gastric tumor. [ Time Frame: 3 years ]

Gastric high grade dysplasia has high malignant potential. Considering this, we set high grade dysplasia as secondary outcome measurement.


Original Secondary Outcome: effect of eradication of Helicobacter pylori on incidence of new cancer and high grade dysplasia development after endoscopic resection of gastric tumor. [ Time Frame: 3 years ]

Gastric high grade dysplasia has high malignant potential. Considering this, if we assume that high grade dysplasia can be incorporated into the carcinoma, we include high grade dysplasia and gastric carcinoma as secondary outcome measurement.


Information By: Seoul National University Hospital

Dates:
Date Received: January 11, 2012
Date Started: January 2005
Date Completion:
Last Updated: March 13, 2012
Last Verified: March 2012