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临床试验/NCT05945511
NCT05945511已完成不适用

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

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 2,295 人开始时间: 2022年9月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,295
试验地点
1
主要终点
biliary complications

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Kidney transplantation patients

排除标准

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

结局指标

主要结局

biliary complications

时间窗: through study completion, an average of 6 year

Incidence rate of biliary complication

post-cholecystectomy complications

时间窗: Within 1month after cholecystectomy

Incidence rate of post-cholecystectomy complication

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Woo Hyun Paik

Professor

Seoul National University Hospital

研究点 (1)

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