Is Routine Use of Histopathological Examination Necessary After Cholecystectomy ?

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02654873

Enrollment

1000

Registered

2016-01-13

Start date

2015-12-31

Completion date

2018-05-31

Last updated

2019-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholelithiasis

Keywords

histopathology, gallbladder, specimen

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Turkey (Türkiye)

Outcome results