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

NCT07084493 | Not Yet Recruiting DMC

• 1 other identifier: ERCP in CBD stones
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Calcular Obstructive Jaundice

Keywords

CBD stones, ERCP

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

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

Interventions

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

CASE WITH cbd STONES

biliary stent DEVICE

prophylactic CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm double-pigtail stent

CASE WITH cbd STONES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, 71511, Egypt

Location

Related Links

• Related Info

Central Study Contacts

Huda Mokhtar Huda Mokhtar, Assistant lecturer, master degree

CONTACT

0201154664323; hudamokhtar2571994@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: 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.

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 24, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

EG (1)