Incidental Cancer in Gallbladder Surgical Specimens Focus... | NCT04352478

Studies
Incidental Cancer in Gallbladder Surgical Specimens Focus on Elderly Patients

NCT04352478

Sponsor

Dr. Ersin Arslan Education and Training Hospital

Status

Completed

Last Update Posted

Apr 22, 2020Actual

Enrollment

2,389Actual

Phase

Not provided

Conditions

Pathology

Interventions

Histopathological result

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 20, 2020Actual

Primary Completion Date

Apr 1, 2020Actual

Completion Date

Apr 13, 2020Actual

First Submitted Date

Apr 13, 2020

First Submission Date that Met QC Criteria

Apr 15, 2020

First Posted Date

Apr 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2020

Last Update Posted Date

Apr 22, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ufuk Uylas, Specialist, Dr. Ersin Arslan Education and Training HospitalPrincipal Investigator

Lead Sponsor

Dr. Ersin Arslan Education and Training HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The investigators aimed to incidental gallbladder cancer and compare other pathology results with elderly patients.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,389Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Elder		elderly (≥60 years old).	Diagnostic Test: Histopathological result
Young		young (<60 years old)	Diagnostic Test: Histopathological result

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Histopathological result	Diagnostic Test	Incidental gallbladder cancer and other pathology	Elder Young

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of Incidental Cancer	Number of Participants with adenocarcinom	2 or 3 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

acute cholecystectomy
elective cholecystectomy

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ufuk Uylas	Dr. Ersin Arslan Training and Resource Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr. Ersin Arslan Training and Resource Hospital		Gaziantep			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002764	Cholecystitis
D002769	Cholelithiasis
D005706	Gallbladder Neoplasms

Ancestor Terms

ID	Term
D005705	Gallbladder Diseases
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D001661	Biliary Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided