This trial is active, not recruiting.

Condition cholelithiasis
Sponsor Sisli Etfal Training & Research Hospital
Collaborator Bezmialem Vakif University
Start date December 2015
End date October 2016
Trial size 1000 participants
Trial identifier NCT02654873, Sislietfal


Cholecystectomy has been made with benign conditions usually. The aim of this study is to compare the macroscopic evaluations of the cholecystectomy specimens with it's histopathological examinations.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Benign pathology specimens with macroscopically
Suspicious group includes the conditions such as increasing of the gallbladder wall thickness, having calcifications or polyps in the gallbladder.
Malign group includes the conditions such as detecting mass or irregularities in the gallbladder wall.

Primary Outcomes

The comparison of macroscopic and histopathologic examination of the cholecystectomy specimen with 1000 cases
time frame: 15 days

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Subject has cholelithiasis Exclusion Criteria: - Subject has acute cholecystitis - Subject has perforated gallbladder - Subject has malignancy - Subject has polyps in the gallbladder - Subject has increasing wall thickness of the gallbladder - Subject has malignancy in the preoperative ultrasonography in the gallbladder - Subject has pregnancy

Additional Information

Principal investigator Huseyin Bektasoglu, M.D.
Description Cholecystectomy is one of the most frequently performed surgery in the world and often made with benign conditions. Routinely cholecystectomy specimens sent for histopathologic examination. The histopathologic examination of the cholecystectomy specimens are benign in most of the cases and the incidental malignancy of the gallbladder is 2-2.9% in the literature. The histopathologic evaluations of the gallbladder come with additional workload for pathology and surgery departments. Also there is additional cost for the patients. Because of that the idea of selective histopathologic examination has been raised.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Sisli Etfal Training & Research Hospital.