An interventional study of CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm OR double-pigtail stent and biliary stent in Calcular Obstructive Jaundice, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-07.
Sponsored by Assiut University · Not applicable, Interventional, and Prevention
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.
Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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"Inclusion Criteria":
"Exclusion 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.
Device: CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm OR 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
prophylactic CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm double-pigtail stent
Recurrence of CBD stones within 3 months, confirmed by imaging or ERCP.
Recurrence of CBD stones within 3 months, confirmed by imaging or ERCP.
Time frame: 3 months
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Assiut University