Ignite Creation Date:
2024-05-06 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05945511
Status:
COMPLETED
Last Update Posted:
2023-07-14
First Post:
2023-06-26
Brief Title:
Silent Gallbladder Stone in Kidney Transplantation Recipients Should it be Treated
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
Silent Gallbladder Stone in Kidney Transplantation Recipients Should it be Treated
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 24-94 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
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 24-94 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None