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NCT Number: NCT07084493

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

"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.

Treatment and study plan

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

biliary stent

Device

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

Primary outcomes

  1. Recurrence of CBD stones within 3 months, confirmed by imaging or ERCP.

    Time frame: 3 months

    Recurrence of CBD stones within 3 months, confirmed by imaging or ERCP.

Study contacts

Contact information is provided by the study sponsor or research team.

Huda Mokhtar Huda Mokhtar, Assistant lecturer, master degree

CONTACT

[email protected]

0201154664323

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

*Effect of Prophylactic Common Bile Duct Stenting Versus Non Stenting on Recurrence of Common Bile Duct Stones in Patients Awaiting Cholecystectomy*

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.