Is Routine Use of Histopathological Examination Necessary After Cholecystectomy ?

Completed

• Conditions: Cholelithiasis

• Registration Number: NCT02654873
• Lead Sponsor: Sisli Hamidiye Etfal Training and Research Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-01-10
• Study First Submitted QC: 2016-01-11
• Study First Posted: 2016-01-13
• Primary Completion: 2017-10
• Study Completion: 2018-05
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-16
• Last Update Posted: 2019-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The comparison of macroscopic and histopathologic examination of the cholecystectomy specimen with 1000 cases	15 days	The 1000 cholecystectomy specimens will be evaluated macroscopically by two experienced surgeons with a longitudinal incision to the gallbladder. The specimens will be grouped as benign, suspicious, malign according to the surgeon's decision. To confirm the surgeon's macroscopic evaluation, all of the specimens will be evaluated histopathologically. The results of macroscopic and histopathological examinations will be compared.

Trial Locations

Locations (6)

Bursa Yuksek Ihtisas Training and Research Hospital; 🇹🇷 Bursa, Turkey

Bezmialem Vakif University; 🇹🇷 Istanbul, Turkey

Erzincan University; 🇹🇷 Erzincan, Turkey

Sisli Etfal Training and Research Hospital; 🇹🇷 Istanbul, Turkey

Arnavutkoy State Hospital; 🇹🇷 Istanbul, Turkey

Istanbul Training and Research Hospital; 🇹🇷 Istanbul, Turkey