Clinical trial NCT02654873: Is Routine Use of Histopathological Examination Necessary After Cholecystectomy ?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholelithiasis
Keywords: histopathology
gallbladder
specimen
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Bezmialem Vakif University
name: Istanbul Training and Research Hospital
name: Erzincan University
name: Arnavutkoy State Hospital
name: Bursa Yüksek İhtisas Education and Research Hospital
First posted: 2016-01-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1000 patients who is operated with non inflamated cholelithiasis will be included to this study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The comparison of macroscopic and histopathologic examination of the cholecystectomy specimen with 1000 cases
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yuksek Ihtisas Training and Research Hospital
city: Erzincan
country: Turkey
facility: Erzincan University
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
city: Istanbul
country: Turkey
facility: Sisli Etfal Training and Research Hospital
city: Istanbul
country: Turkey
facility: Arnavutkoy State Hospital
city: Istanbul
country: Turkey
facility: Istanbul Training and Research Hospital
Study officials:
affiliation: Sisli Etfal Training and Research Hospital
name: Ufuk Oguz Idiz, M.D.
role: STUDY_DIRECTOR
affiliation: Bezmialem Vakif University
name: Huseyin Bektasoglu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.