Calcular Obstructive Jaundice
Conditions
Keywords
CBD stones, ERCP
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.
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
DEVICECBD 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
DEVICEbiliary stent
prophylactic CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm double-pigtail stent
Sponsors
Assiut University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Following ERCP and biliary duct clearance, participants will be randomly assigned in a 1:1 ratio to either: Stent Group: Placement of a prophylactic CBD stent will be placed. Control Group: No stent placement after biliary clearance. Patients will be monitored every month until cholecystectomy or up to 3 months, whichever comes first. Follow-up includes: Clinical assessment. LFTs and pancreatic enzymes. Imaging: US (MRCP if symptomatic). Stent removal (if placed) at 3 months or earlier if symptomatic. Repeat ERCP for recurrence.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of CBD stones within 3 months, confirmed by imaging or ERCP. | 3 months | Recurrence of CBD stones within 3 months, confirmed by imaging or ERCP. |
Countries
Egypt
Contacts
Primary ContactHuda Mokhtar Huda Mokhtar, Assistant lecturer, master degree
Outcome results
None listed