Silent Gallbladder Stone in Kidney Transplantation Recipients: Should it be Treated?

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.

Study Overview

• Status: Completed
• Conditions: Kidney Transplantation; Gallbladder Stones

Detailed Description

Kidney transplantation (KT) is the best treatment option for patients with end-stage kidney disease (ESKD) although donor deficit remains a main problem. Hence, the survival extension of both KT recipients and their invaluable grafts should be prioritized. A thorough pretransplant evaluation is essential in identifying and managing any risk factors associated with adverse outcomes for both patients and grafts following KT. Candidates typically undergo various types of intra-abdominal imaging before KT surgery to assess the anatomical structures of the renal vasculature and urinary tract, which is crucial for detailed surgery planning and to rule out any pre-existing malignancies or concealed infectious complications. Asymptomatic gallstones may be incidentally discovered during the evaluation, but optimal management and follow-up strategies for these gallstones in KT candidates remain unclear.

Asymptomatic gallstone management in the general population is typically based on the risk of developing relevant symptoms or complications. Previous large cohort studies have revealed that individuals with asymptomatic gallstones have a lifetime risk of approximately 7%-26% of developing serious symptoms or gallstone-related complications such as acute cholecystitis, acute cholangitis, and acute pancreatitis. The aftereffects should not be ignored even if cholecystectomy is performed in patients with asymptomatic gallstones. The incidence of complications after cholecystectomy in the general population is approximately 2.4%-9.4%, and the mortality rate is <1%. Therefore, prophylactic cholecystectomy is not usually recommended in the general population with asymptomatic gallstones.

On the contrary, patients who underwent solid organ transplantation, including KT, had higher rates of both asymptomatic gallstones and postoperative complications after cholecystectomy than the general population. Several studies have revealed that 18%-39% of KT recipients with asymptomatic gallstones develop gallstone-related complications requiring surgery. The postoperative complication rate was approximately 15% and the mortality rate was up to 7% when subsequent cholecystectomy was performed, which indicates an increased morbidity, especially in the case of open surgery. Considering both, the benefit of prophylactic cholecystectomy in KT recipients is difficult to define. Several studies recommend prophylactic cholecystectomy for patients with asymptomatic gallstones who underwent solid organ transplants or those who will require immunosuppressants. Routine cholecystectomy is not typically performed by most transplant centers, despite these recommendations, even when silent gallstones are discovered during the pretransplant evaluation.

Therefore, this retrospective cohort analysis 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.

• Study Type: Observational
• Enrollment (Actual): 2295

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Kidney transplantation patients

Exclusion Criteria:

1. patients aged <18 years
2. patients followed for <3 months
3. patients without evidence of gallstones on abdominal imaging studies

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Kidney transplant patients; KT recipients at Seoul national university hospital from January 2005 to July 2022.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft failure (GF)	Incidence rate of graft failure after kidney transplantation	After KT to study completion, an average of 6 year
Death-censored graft failure (DCGF)	Incidence rate of Death-censored graft failure after kidney transplantation	After KT to study completion, an average of 6 year
All-cause mortality	Incidence rate of death	through study completion, an average of 6 year

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Myeong Hwan Lee, M.D, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2022
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Gallstones; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: 2209-029-1355

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