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NCT Number: NCT02654873

Is Routine Use of Histopathological Examination Necessary After Cholecystectomy ?

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.

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Key information

Conditions

Cholelithiasis Biliary Tract Diseases Digestive System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bursa Yuksek Ihtisas Training and Research Hospital, Bursa, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The comparison of macroscopic and histopathologic examination of the cholecystectomy specimen with 1000 cases

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Collaborators

  • Arnavutkoy State Hospital
  • Bezmialem Vakif University
  • Bursa Yuksek Ihtisas Training and Research Hospital
  • Erzincan University
  • Istanbul Training and Research Hospital

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jan 13, 2016
Registry last updated
Feb 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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