*Effect of Prophylactic CBD Stenting Versus Non Stenting on Recurrence of CBD Stones in Patients Awaiting Cholecystectomy*
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm OR double-pigtail stent, biliary stent.
- Who it may be relevant to
- Registry conditions: Calcular Obstructive Jaundice. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
*Effect of Prophylactic Common Bile Duct Stenting Versus Non Stenting on Recurrence of Common Bile Duct Stones in Patients Awaiting Cholecystectomy*
Overview
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.
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.
Interventions
- Device CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm OR double-pigtail stent
prophylactic CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm double-pigtail stent - Device biliary stent
prophylactic CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm double-pigtail stent
Primary outcome measures
- Recurrence of CBD stones within 3 months, confirmed by imaging or ERCP. [Time frame: 3 months]
Eligibility criteria
"Inclusion Criteria":
- Age > 18 years.
- Documented CBD stones by various imaging or ERCP.
- Successful biliary clearance by ERCP.
- Scheduled for elective cholecystectomy within 3 months.
- Provide written informed consent.
"Exclusion Criteria":
- Previous biliary surgery.
- Known malignancy involving the biliary system.
- Comorbid conditions preventing surgery such as bleeding tendency.
- Pregnancy.
- Failure to obtain consent.
- Failed stone clearance.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Assiut university — Asyut
Identifiers
NCT: NCT07084493 · ERCP in CBD stones