Clinical trial NCT01810081: Gallstones and Concomitant Gastric Helicobacter Pylori Infection
Official title: Study of Relationship Between Gallstones and Concomitant Gastric Helicobacter Pylori Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cholelithiasis
Keywords: Cholelithiasis
Gastric H.Pylori infection
H.Pylori infection
Gastric mucosa
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2013-03-13
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ninety-four patients with symptomatic gallstones undergoing laparoscopic cholecystectomy were enrolled for the study.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gallstones and concomitant H.Pylori infection of the gastric mucosa
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: marmara University School of Medicine
Study officials:
affiliation: Marmara University
name: A.Ozdemir Aktan, md,PROF
role: STUDY_DIRECTOR
References: