Management Strategy of Polypoid Lesions of the Gallbladder | NCT04762797

Studies
Management Strategy of Polypoid Lesions of the Gallbladder

NCT04762797

Sponsor

Peking Union Medical College Hospital

Status

Completed

Last Update Posted

Feb 21, 2021Actual

Enrollment

672Actual

Phase

Not provided

Conditions

Polyp Gallbladder

Interventions

Countries

China

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

Jan 2015

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 1, 2015Actual

Primary Completion Date

May 31, 2020Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Feb 17, 2021

First Submission Date that Met QC Criteria

Feb 17, 2021

First Posted Date

Feb 21, 2021Actual

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

Feb 17, 2021

Last Update Posted Date

Feb 21, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

We retrospectively review a single-center cohort of gallbladder polyps from January 2015 to May 2020. Univariate and multivariable analyses were performed to extract potential risky factors of neoplastic polyps. Also, a comparison was conducted between laparoscopic cholecystectomy (LC) and laparoscopic polypectomy (LP) to explore factors affecting surgeons' decision on LC or LP.

Detailed Description

Not provided

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

672Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non-neoplastic group		Gallbladder polyps with pathological diagnosis of cholesterol polyps or inflammatory polyps are classified into "Non-neoplastic group".	Other: Non
Neoplastic group		Gallbladder polyps pathologically diagnosed as adenocarcinoma, adenoma, adenomyosis, or other malignancies are classified into "Neoplastic group".	Other: Non

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non	Other	This is a retrospective study, without intervention.	Neoplastic group Non-neoplastic group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pathological diagnosis of polyps	Pathological diagnosis of polyps	Up to two weeks after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Surgical indications for LC included polyp diameter over 10 millimeters, or polyps accompanied by GB stones, or consideration of neoplastic polyps. Surgical indications for GB-preserving surgery included GB with normal emptying function and polyp diameter smaller than 10 millimeters, or consideration of benign non-neoplastic polyps, or asymptomatic polyps.

Exclusion Criteria:

Those do not fit for laparoscopic surgery.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

surgical candidates of laparoscopic cholecystectomy or laparoscopic polypectomy.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Qiang Qu, Doctor	Peking Union Medical College Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital		Beijing			China

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