*Effect of Prophylactic CBD Stenting Versus Non Stenting on Recurrence of CBD Stones in Patients Awaiting Cholecystectomy*

Assiut University

Status: Not yet enrolling

Conditions: Calcular Obstructive Jaundice

Treatments: Device: CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm OR double-pigtail stent; Device: biliary stent

Study type: Interventional

Funder types: Other

Identifiers

NCT07084493

ERCP in CBD stones

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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88 participants in 1 patient group

CASE WITH cbd STONES

Active Comparator group

Description:

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.

Treatment:

Device: biliary stent

Device: CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm OR double-pigtail stent