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Gallstones and Concomitant Gastric Helicobacter Pylori Infection

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by Marmara University
Sponsor:
Information provided by (Responsible Party):
M.Umit UGURLU, Marmara University
ClinicalTrials.gov Identifier:
NCT01810081
First received: March 6, 2013
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

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.


Condition
Cholelithiasis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Relationship Between Gallstones and Concomitant Gastric Helicobacter Pylori Infection

Resource links provided by NLM:


Further study details as provided by Marmara University:

Primary Outcome Measures:
  • Gallstones and concomitant H.Pylori infection of the gastric mucosa [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The relationship between gastric H.Pylori infection and comcomitant gallstones will be evaluated


Estimated Enrollment: 94
Study Start Date: March 2013
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
cholecystectomy
cholecystectomy group: H.Pylori infection in gall bladder

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Ninety-four patients with symptomatic gallstones undergoing laparoscopic cholecystectomy were enrolled for the study.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01810081

Contacts
Contact: M.Umit UGURLU, MD +905324108010 umitugurlu@gmail.com

Locations
Turkey
marmara University School of Medicine Not yet recruiting
Istanbul, Turkey
Contact: M.Umit UGURLU, MD    +905324108010    umitugurlu@gmail.com   
Sponsors and Collaborators
Marmara University
Investigators
Study Director: A.Ozdemir Aktan, md,PROF Marmara University
  More Information

No publications provided

Responsible Party: M.Umit UGURLU, Assist.Prof., Marmara University
ClinicalTrials.gov Identifier: NCT01810081     History of Changes
Other Study ID Numbers: B.30.2.MAR.0.01.02/AEK/73
Study First Received: March 6, 2013
Last Updated: March 11, 2013
Health Authority: Turkey: Ethics Committee

Keywords provided by Marmara University:
Cholelithiasis
Gastric H.Pylori infection
H.Pylori infection
Gastric mucosa

Additional relevant MeSH terms:
Cholecystolithiasis
Cholelithiasis
Gallstones
Communicable Diseases
Helicobacter Infections
Infection
Bacterial Infections
Biliary Tract Diseases
Calculi
Digestive System Diseases
Gallbladder Diseases
Gram-Negative Bacterial Infections
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 21, 2014