Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-30 @ 11:54 PM
Study NCT ID:
NCT07084493
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-07
First Post:
2025-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
*Effect of Prophylactic CBD Stenting Versus Non Stenting on Recurrence of CBD Stones in Patients Awaiting Cholecystectomy*
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
*Effect of Prophylactic Common Bile Duct Stenting Versus Non Stenting on Recurrence of Common Bile Duct Stones in Patients Awaiting Cholecystectomy*
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
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:
Primary objective:
Compare recurrence rates of CBD stones in stented versus non-stented patients.
Secondary objectives:
Identify predictors of stone recurrence. Assess the incidence and risk factors for post-ERCP complications. Evaluate time to recurrence and rate of hospital readmissions. Explore impact on quality of life and ease of subsequent cholecystectomy.
Compare recurrence rates of CBD stones in stented versus non-stented patients.
Secondary objectives:
Identify predictors of stone recurrence. Assess the incidence and risk factors for post-ERCP complications. Evaluate time to recurrence and rate of hospital readmissions. Explore impact on quality of life and ease of subsequent cholecystectomy.
Detailed Description:
Choledocholithiasis, the presence of stones in the common bile duct (CBD), occurs in 10-20% of patients with symptomatic gallstones and can lead to severe complications such as obstructive jaundice, cholangitis, and pancreatitis Endoscopic retrograde cholangiopancreatography (\*\*ERCP\*\*) with stone extraction is the gold standard treatment, achieving \>90% success rates in ductal clearance.
Despite successful initial clearance, CBD stone recurrence remains a significant issue, with reported rates ranging from 4% to 24% .
To reduce recurrence, prophylactic biliary stenting has been proposed, particularly in high-risk patients (e.g., large or multiple stones, dilated CBD, periampullary diverticulum) However, its routine use remains controversial due to conflicting evidence on efficacy, stent-related complications (e.g., migration, occlusion, cholangitis), and increased healthcare costs.
Despite successful initial clearance, CBD stone recurrence remains a significant issue, with reported rates ranging from 4% to 24% .
To reduce recurrence, prophylactic biliary stenting has been proposed, particularly in high-risk patients (e.g., large or multiple stones, dilated CBD, periampullary diverticulum) However, its routine use remains controversial due to conflicting evidence on efficacy, stent-related complications (e.g., migration, occlusion, cholangitis), and increased healthcare costs.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: