NCT04352478

Brief Summary

Causes such as long-term stones and polyp are thought to play a role in the etiology of gallbladder cancer. The routine histopathological examination provides the detection of incidental gallbladder cancers. It should be remembered that acute or chronic cholecystitis accompanied by the thicked wall and a prolonged history of gallstones may be the cause of malignancy, especially in elderly patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,389

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

January 20, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
Last Updated

April 22, 2020

Status Verified

April 1, 2020

Enrollment Period

2 months

First QC Date

April 13, 2020

Last Update Submit

April 20, 2020

Conditions

Pathology

Keywords

cholecystectomycholecystitischolelithiasisgallbladder neoplasmshistopathologysurgical procedures

Outcome Measures

Primary Outcomes (1)

  • Rate of Incidental Cancer

    Number of Participants with adenocarcinom

    2 or 3 week

Study Arms (2)

Elder

elderly (≥60 years old).

Diagnostic Test: Histopathological result

Young

young (\<60 years old)

Diagnostic Test: Histopathological result

Interventions

Histopathological resultDIAGNOSTIC_TEST

Incidental gallbladder cancer and other pathology

ElderYoung

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent cholecystectomy between January 2016 and February 2020 at our hospital

You may qualify if:

  • acute cholecystectomy
  • elective cholecystectomy

You may not qualify if:

  • lack of data
  • incidental cholecystectomy,
  • cholecystectomy secondary to trauma
  • cholecystectomy secondary to malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Ersin Arslan Training and Resource Hospital

Gaziantep, Turkey (Türkiye)

Location

MeSH Terms

Conditions

CholecystitisCholelithiasisGallbladder Neoplasms

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System DiseasesBiliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Ufuk Uylas

    Dr. Ersin Arslan Training and Resource Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist

Study Record Dates

First Submitted

April 13, 2020

First Posted

April 20, 2020

Study Start

January 20, 2020

Primary Completion

April 1, 2020

Study Completion

April 13, 2020

Last Updated

April 22, 2020

Record last verified: 2020-04

Locations

TU(1)