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

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05945511
• Other study ID #: 2209-029-1355
• Status: Completed
• Start date: September 7, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: July 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2295
• Est. completion date: June 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallbladder Stones
• Gallstones
• Kidney Transplantation

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	biliary complications	Incidence rate of biliary complication	through study completion, an average of 6 year
Primary	post-cholecystectomy complications	Incidence rate of post-cholecystectomy complication	Within 1month after cholecystectomy
Secondary	Graft failure (GF)	Incidence rate of graft failure after kidney transplantation	After KT to study completion, an average of 6 year
Secondary	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
Secondary	All-cause mortality	Incidence rate of death	through study completion, an average of 6 year