Gallstones and Concomitant Gastric Helicobacter Pylori Infection
Overview
In this study, the presence of H.Pylori in the gallbladder mucosa of patients with symptomatic gallstones undergoing cholecystectomy was investigated. Concomitant H.Pylori infection of the gastric mucosa was also investigated to study the relationship of gastric H.Pylori infection to gallstones. It was hypothesized that H.Pylori infection of the gastric mucosa may have a role in the formation of gallstones.
Full Title of Study: “Study of Relationship Between Gallstones and Concomitant Gastric Helicobacter Pylori Infection”
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: May 2013
Detailed Description
Gallstone disease is one of the most common problems affecting the digestive tract where autopsy reports show a prevalence of 11-36% . The prevalence of gallstones is related to many factors including age, gender, and ethnic background. Women are three times more likely to develop gallstones than man and first-degree relatives have a two-fold increased prevalence . However, the etiology of gallstone formation beginning with the change in the composition of bile, leading to stones is not clear. The association between Helicobacter pylori (H.Pylori) and gallstones has been investigated but not clearly demonstrated. H.Pylori is a gram negative and micro-aerophilic microorganism that can cause chronic gastritis, gastric and duodenal ulcers, gastric adenocarcinoma and lymphoma of gastric mucosa-related lymphoid tissue (MALToma) . Relationship of H.Pylori with diseases of organs other than the stomach and duodenum has also been investigated and reported . H.Pylori have been detected in the gallbladder mucosa of patients with gallstones . In this study, the presence of H.Pylori in the gallbladder mucosa of patients with symptomatic gallstones undergoing cholecystectomy was investigated. Concomitant H.Pylori infection of the gastric mucosa was also investigated to study the relationship of gastric H.Pylori infection to gallstones. It was hypothesized that H.Pylori infection of the gastric mucosa may have a role in the formation of gallstones.
Arms, Groups and Cohorts
- cholecystectomy
- cholecystectomy group: H.Pylori infection in gall bladder
Clinical Trial Outcome Measures
Primary Measures
- Gallstones and concomitant H.Pylori infection of the gastric mucosa
- Time Frame: 3 months
- The relationship between gastric H.Pylori infection and comcomitant gallstones will be evaluated
Participating in This Clinical Trial
Inclusion Criteria
- Patients with acute cholecystitis, cholangitis, biliary and hepatic tumors, Crohn's disease, and previous gastric surgery were not considered suitable for evaluation. Exclusion Criteria:
- Patients undergoing ERCP (endoscopic retrograde cholangio-pancreatography) and patients who have received H.Pylori eradication treatment in the last 6 month were also excluded from the study.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Marmara University
- Provider of Information About this Clinical Study
- Principal Investigator: M.Umit UGURLU, Assist.Prof. – Marmara University
- Overall Official(s)
- A.Ozdemir Aktan, md,PROF, Study Director, Marmara University
- Overall Contact(s)
- M.Umit UGURLU, MD, +905324108010, umitugurlu@gmail.com
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