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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CASE WITH cbd STONES | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm OR double-pigtail stent | Device | prophylactic CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm double-pigtail stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of CBD stones within 3 months, confirmed by imaging or ERCP. | Recurrence of CBD stones within 3 months, confirmed by imaging or ERCP. | 3 months |
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"Inclusion Criteria":
"Exclusion Criteria":
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huda Mokhtar Huda Mokhtar, Assistant lecturer, master degree | Contact | 0201154664323 | hudamokhtar2571994@aun.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut university | Asyut | 71511 | Egypt |
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| Label | URL |
|---|---|
| Related Info | View source |
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SPSS version 22 will be used. Continuous variables: mean ± SD or median (IQR), compared via t-test or Mann-Whitney.
Categorical variables: chi-square or Fisher's exact test. Kaplan-Meier for time-to-event outcomes. Multivariate regression to identify predictors. P < 0.05 considered significant.
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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.
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| biliary stent | Device | prophylactic CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm double-pigtail stent |
|