NCT04762797

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
672

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
Last Updated

February 21, 2021

Status Verified

January 1, 2015

Enrollment Period

5.4 years

First QC Date

February 17, 2021

Last Update Submit

February 17, 2021

Conditions

Polyp Gallbladder

Keywords

gallbladder polyp; laparoscopic cholecystectomy; polypectomy

Outcome Measures

Primary Outcomes (1)

  • Pathological diagnosis of polyps

    Pathological diagnosis of polyps

    Up to two weeks after surgery

Study Arms (2)

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

NonOTHER

This is a retrospective study, without intervention.

Neoplastic groupNon-neoplastic group

Eligibility Criteria

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

surgical candidates of laparoscopic cholecystectomy or laparoscopic polypectomy.

You may qualify if:

  • 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.

You may not qualify if:

  • Those do not fit for laparoscopic surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

Study Officials

  • Qiang Qu, Doctor

    Peking Union Medical College Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2021

First Posted

February 21, 2021

Study Start

January 1, 2015

Primary Completion

May 31, 2020

Study Completion

December 31, 2020

Last Updated

February 21, 2021

Record last verified: 2015-01

Locations

CN(1)