Is Routine Use of Histopathological Examination Necessary After Cholecystectomy ?

Cholelithiasis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02654873
• Other study ID #: Sislietfal
• Status: Completed
• Start date: December 2015
• Est. completion date: May 2018

Study information

• Verified date: February 2019
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: May 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Locations

Country	Name	City	State
Turkey	Bursa Yuksek Ihtisas Training and Research Hospital	Bursa
Turkey	Erzincan University	Erzincan
Turkey	Arnavutkoy State Hospital	Istanbul
Turkey	Bezmialem Vakif University	Istanbul
Turkey	Istanbul Training and Research Hospital	Istanbul
Turkey	Sisli Etfal Training and Research Hospital	Istanbul

Sponsors (6)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital	Arnavutkoy State Hospital, Bezmialem Vakif University, Bursa Yüksek Ihtisas Education and Research Hospital, Erzincan University, Istanbul Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Deng YL, Xiong XZ, Zhou Y, Shrestha A, Li FY, Cheng NS. Selective histology of cholecystectomy specimens--is it justified? J Surg Res. 2015 Jan;193(1):196-201. doi: 10.1016/j.jss.2014.07.039. Epub 2014 Jul 24. — View Citation

Elshaer M, Gravante G, Yang Y, Hudson S, Thomas K, Sorge R, Al-Hamali S, Kelkar A, Ebdewi H. Routine versus selective histologic analysis of gallbladder specimens for the detection of incidental gallbladder cancers. A retrospective review over 9 years of activity with a special focus on patients' age. Am J Surg. 2014 Sep;208(3):444-9. doi: 10.1016/j.amjsurg.2013.12.038. Epub 2014 Apr 3. — View Citation

Siddiqui FG, Memon AA, Abro AH, Sasoli NA, Ahmad L. Routine histopathology of gallbladder after elective cholecystectomy for gallstones: waste of resources or a justified act? BMC Surg. 2013 Jul 8;13:26. doi: 10.1186/1471-2482-13-26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The comparison of macroscopic and histopathologic examination of the cholecystectomy specimen with 1000 cases	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.	15 days