Is Routine Use of Histopathological Examination Necessary After Cholecystectomy ?

NCT ID: NCT02654873

Last Updated: 2019-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2018-05-31

Brief Summary

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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

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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.

Conditions

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Cholelithiasis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Benign

Benign pathology specimens with macroscopically

No interventions assigned to this group

Suspicious

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

No interventions assigned to this group

Malign

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role collaborator

Istanbul Training and Research Hospital

OTHER_GOV

Sponsor Role collaborator

Erzincan University

OTHER

Sponsor Role collaborator

Arnavutkoy State Hospital

OTHER

Sponsor Role collaborator

Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role collaborator

Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ufuk Oguz Idiz

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ufuk Oguz Idiz, M.D.

Role: STUDY_DIRECTOR

Sisli Etfal Training and Research Hospital

Huseyin Bektasoglu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Vakif University

Locations

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Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, , Turkey (Türkiye)

Site Status

Erzincan University

Erzincan, , Turkey (Türkiye)

Site Status

Bezmialem Vakif University

Istanbul, , Turkey (Türkiye)

Site Status

Sisli Etfal Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Arnavutkoy State Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Istanbul Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 24811928 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23834815 (View on PubMed)

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.

Reference Type RESULT
PMID: 25151466 (View on PubMed)

Other Identifiers

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Sislietfal

Identifier Type: -

Identifier Source: org_study_id

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