NCT02654873

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 10, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 13, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

February 19, 2019

Status Verified

February 1, 2019

Enrollment Period

1.8 years

First QC Date

January 10, 2016

Last Update Submit

February 16, 2019

Conditions

Cholelithiasis

Keywords

histopathologygallbladderspecimen

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Benign

Benign pathology specimens with macroscopically

Suspicious

Suspicious group includes the conditions such as increasing of the gallbladder wall thickness, having calcifications or polyps in the gallbladder.

Malign

Malign group includes the conditions such as detecting mass or irregularities in the gallbladder wall.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

1000 patients who is operated with non inflamated cholelithiasis will be included to this study.

You may qualify if:

  • Subject has cholelithiasis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Turkey (Türkiye)

Location

Erzincan University

Erzincan, Turkey (Türkiye)

Location

Bezmialem Vakif University

Istanbul, 34093, Turkey (Türkiye)

Location

Sisli Etfal Training and Research Hospital

Istanbul, 34371, Turkey (Türkiye)

Location

Arnavutkoy State Hospital

Istanbul, Turkey (Türkiye)

Location

Istanbul Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 24811928BACKGROUND

  • 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.

    PMID: 23834815BACKGROUND

  • 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.

    PMID: 25151466RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

cholecystectomy specimens

MeSH Terms

Conditions

Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Study Officials

  • Ufuk Oguz Idiz, M.D.

    Sisli Etfal Training and Research Hospital

    STUDY DIRECTOR

  • Huseyin Bektasoglu, M.D.

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

January 10, 2016

First Posted

January 13, 2016

Study Start

December 1, 2015

Primary Completion

October 1, 2017

Study Completion

May 1, 2018

Last Updated

February 19, 2019

Record last verified: 2019-02

Locations

TU(6)