Double Stent for Biliary Stones in Cirrhotic Patients

NCT07337291 | Completed

• 2 other identifiers: 0128261229500787
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, single-center, interventional study enrolled 400 cirrhotic patients with large or complex common bile duct (CBD) stones that could not be removed during an initial Endoscopic Retrograde Cholangiopancreatography (ERCP). The study compared four different plastic biliary stenting strategies (single 10 Fr, double 10 Fr, single 11.5 Fr, and single 10 Fr pigtail stents) to determine the optimal approach for facilitating successful stone clearance in a subsequent ERCP and minimizing complications in this high-risk patient population.

Conditions

Liver Circulation; Choledocholithiasis; Stent

Keywords

ERCP; Biliary Stent; Double Stent; Liver Cirrhosis; Non-Retrievable Stones; High-Risk Patients

Outcome Measures

Primary Outcomes (2)

• Stent Patency

  Time from stent placement until clinical or biochemical evidence of stent occlusion (e.g., cholangitis, elevated liver enzymes, or imaging findings).

  6 months

• Successful Stone Clearance in Second ERCP

  The proportion of patients in each group achieving complete clearance of common bile duct stones during the second, planned ERCP session.

  6 months

Secondary Outcomes (3)

• Incidence of Procedure-Related Complications

  From stenting until 30 days after the second ERCP.

• Reduction in Stone Size

  6 months

• All-Cause Mortality

  12 months

Study Arms (4)

Single 10 Fr Plastic Stent

EXPERIMENTAL

Placement of a single 10 French (Fr), 10 cm plastic biliary stent.

Device: Single 10 Fr Plastic Biliary Stent

Double 10 Fr Plastic Stents

EXPERIMENTAL

Placement of two 10 French (Fr), 10 cm plastic biliary stents side-by-side.

Device: Two 10 Fr Plastic Biliary Stent

Single 11.5 Fr Plastic Stent

EXPERIMENTAL

Placement of a single 11.5 French (Fr), 10 cm plastic biliary stent.

Device: Single 11.5 Fr Plastic Biliary Stent

Single 10 Fr Pigtail Stent

EXPERIMENTAL

Placement of a single 10 French (Fr), 10 cm pigtail plastic biliary stent.

Device: Single 10 Fr Pigtail Stent

Interventions

Single 10 Fr Plastic Biliary Stent DEVICE

Single 10 Fr, 10 cm plastic stent placed endoscopically.

Single 10 Fr Plastic Stent

Two 10 Fr Plastic Biliary Stent DEVICE

Two 10 Fr, 10 cm plastic stents placed endoscopically.

Double 10 Fr Plastic Stents

Single 11.5 Fr Plastic Biliary Stent DEVICE

Single 11.5 Fr, 10 cm plastic stent placed endoscopically.

Single 11.5 Fr Plastic Stent

Single 10 Fr Pigtail Stent DEVICE

Single 10 Fr, 10 cm pigtail plastic stent placed endoscopically.

Single 10 Fr Pigtail Stent

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with established liver cirrhosis.
• Presence of large or complex common bile duct (CBD) stones that were non-retrievable during the initial ERCP.
• Classified as high-risk due to moderate to severe liver disease and/or substantial comorbidities, making them unable to safely tolerate extended endoscopic procedures or surgical intervention.
• Clinically stable and capable of undergoing the scheduled diagnostic and therapeutic procedures.
• Provided signed informed consent before enrollment.

You may not qualify if:

• Non-cirrhotic patients.
• Patients with non-calculous causes of biliary obstruction (e.g., portal biliopathy, benign biliary strictures, or malignant biliary obstruction).
• Acute suppurative cholangitis.
• Contraindications to ERCP.
• Inability to complete the scheduled 12-month follow-up time.

Sponsors & Collaborators

• National Liver Institute, Egypt: lead

Study Sites (1)

National Liver Institute, Menoufia University, Egypt.

Shibīn al Kawm, Menoufia, 32511, Egypt

Location

Related Publications (3)

• Lee TH, Han JH, Kim HJ, Park SM, Park SH, Kim SJ. Is the addition of choleretic agents in multiple double-pigtail biliary stents effective for difficult common bile duct stones in elderly patients? A prospective, multicenter study. Gastrointest Endosc. 2011 Jul;74(1):96-102. doi: 10.1016/j.gie.2011.03.005. Epub 2011 Apr 30.

  PMID: 21531412 BACKGROUND

• Horiuchi A, Nakayama Y, Kajiyama M, Kato N, Kamijima T, Graham DY, Tanaka N. Biliary stenting in the management of large or multiple common bile duct stones. Gastrointest Endosc. 2010 Jun;71(7):1200-1203.e2. doi: 10.1016/j.gie.2009.12.055. Epub 2010 Apr 18.

  PMID: 20400079 BACKGROUND

• Binmoeller KF, Schafer TW. Endoscopic management of bile duct stones. J Clin Gastroenterol. 2001 Feb;32(2):106-18. doi: 10.1097/00004836-200102000-00004.

  PMID: 11205644 BACKGROUND

MeSH Terms

Conditions

Choledocholithiasis; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2026
• First Posted: January 13, 2026
• Study Start: January 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: January 13, 2026

Record last verified: 2025-12

Locations

EG (1)