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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Gallbladder Stones, Kidney Transplantation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Kidney transplantation patients Exclusion Criteria: patients aged <18 years patients followed for <3 months patients without evidence of gallstones on abdominal imaging studies

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Kidney transplant patients<br>KT recipients at Seoul national university hospital from January 2005 to July 2022. | |

What is the study measuring?
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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 |