NCT05945511

Brief Summary

Treatment and follow-up strategies for silent gallbladder (GB) stones in patients before KT (Kidney transplantation) remain unknown. Therefore, we aimed to assess the risk of gallstone-related biliary complications and post-cholecystectomy complications in KT recipients, to elucidate the role of prophylactic cholecystectomy in this population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,295

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

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

September 7, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

June 26, 2023

Last Update Submit

July 11, 2023

Conditions

Gallbladder StonesKidney Transplantation

Outcome Measures

Primary Outcomes (2)

  • biliary complications

    Incidence rate of biliary complication

    through study completion, an average of 6 year

  • post-cholecystectomy complications

    Incidence rate of post-cholecystectomy complication

    Within 1month after cholecystectomy

Secondary Outcomes (3)

  • Graft failure (GF)

    After KT to study completion, an average of 6 year

  • Death-censored graft failure (DCGF)

    After KT to study completion, an average of 6 year

  • All-cause mortality

    through study completion, an average of 6 year

Study Arms (1)

Kidney transplant patients

KT recipients at Seoul national university hospital from January 2005 to July 2022.

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Kidney transplantation recipients with gallstones at Seoul national university hospital from January 2005 to July 2022.

You may qualify if:

  • Kidney transplantation patients

You may not qualify if:

  • patients aged \<18 years
  • patients followed for \<3 months
  • patients without evidence of gallstones on abdominal imaging studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

  • Lee MH, Jang Y, Kang E, Kim YC, Min S 2nd, Lee SH, Cho IR, Paik WH, Lee H. Silent gallbladder stone in kidney transplantation recipients: should it be treated? A retrospective cohort study. Int J Surg. 2024 Jun 1;110(6):3571-3579. doi: 10.1097/JS9.0000000000001394.

    PMID: 38573083DERIVED

MeSH Terms

Conditions

Cholecystolithiasis

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesGallbladder Diseases

Study Officials

  • Myeong Hwan Lee, M.D

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 26, 2023

First Posted

July 14, 2023

Study Start

September 7, 2022

Primary Completion

March 1, 2023

Study Completion

June 1, 2023

Last Updated

July 14, 2023

Record last verified: 2023-07

Locations

KR(1)