Management Strategy of Polypoid Lesions of the Gallbladder

Management Strategy of Polypoid Lesions of the Gallbladder: a Single-center Retrospective Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Polyp Gallbladder
• Intervention / Treatment: Other: Non

• Study Type: Observational
• Enrollment (Actual): 672

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

surgical candidates of laparoscopic cholecystectomy or laparoscopic polypectomy.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-neoplastic group; Gallbladder polyps with pathological diagnosis of cholesterol polyps or inflammatory polyps are classified into "Non-neoplastic group".	Other: Non; This is a retrospective study, without intervention.
Neoplastic group; Gallbladder polyps pathologically diagnosed as adenocarcinoma, adenoma, adenomyosis, or other malignancies are classified into "Neoplastic group".	Other: Non; This is a retrospective study, without intervention.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Director: Qiang Qu, Doctor, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2015
• Primary Completion (ACTUAL): May 31, 2020
• Study Completion (ACTUAL): December 31, 2020

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (ACTUAL): February 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: gallbladder polyp; laparoscopic cholecystectomy; polypectomy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps
• Other Study ID Numbers: PUMCHTF3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No