CBD Stenting vs Non-Stenting for Choledocholithiasis

NCT07331142 | Completed

• 1 other identifier: 035931299
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The role of prophylactic biliary stenting after complete clearance of common bile duct stones in patients awaiting cholecystectomy remains controversial. This randomized controlled trial investigates whether temporary plastic biliary stent placement after documented complete choledocholithiasis clearance reduces the recurrence of choledocholithiasis and biliary complications in patients awaiting cholecystectomy for concomitant cholelithiasis. Between March 2024 and September 2025, 200 patients with concomitant cholelithiasis and choledocholithiasis were randomized to either prophylactic biliary stenting (n=100) or no stenting (n=100) after complete stone clearance documented on occlusion cholangiogram during endoscopic retrograde cholangiopancreatography (ERCP). The primary outcome was symptomatic choledocholithiasis recurrence within 3 months. Secondary outcomes included biliary complications (cholangitis, cholecystitis, post-ERCP pancreatitis, bleeding), radiation exposure metrics, and cost-effectiveness.

Conditions

Choledocholithiasis

Keywords

Choledocholithiasis; cholelithiasis; endoscopic retrograde cholangiopancreatography; stent

Outcome Measures

Primary Outcomes (1)

• Recurrence of Choledocholithiasis

  Radiological or endoscopic evidence of recurrent common bile duct stones documented on imaging (ultrasound, CT, MRCP) or during repeat endoscopy.

  3 months after initial ERCP

Secondary Outcomes (1)

• Biliary Complications

  3 months after initial ERCP

Study Arms (2)

Prophylactic Biliary Stenting Group

EXPERIMENTAL

Patients randomized to this arm receive endoscopic placement of a temporary plastic biliary stent (7-10 French) in the common bile duct after documented complete choledocholithiasis clearance during ERCP. The stent is left in place to maintain bile duct patency during the waiting period before cholecystectomy.

Procedure: Temporary Plastic Biliary Stent Placement; Procedure: Endoscopic Retrograde Cholangiopancreatography with Stone Clearance

No Stenting Group

ACTIVE COMPARATOR

Patients randomized to this arm undergo ERCP with complete choledocholithiasis clearance without placement of a temporary biliary stent. They proceed to laparoscopic cholecystectomy without the protective stent.

Procedure: Endoscopic Retrograde Cholangiopancreatography with Stone Clearance

Interventions

Temporary Plastic Biliary Stent Placement PROCEDURE

Endoscopic placement of a temporary plastic biliary stent (7-10 French gauge) across the sphincter of Oddi after documented complete choledocholithiasis clearance on occlusion cholangiogram during ERCP. The stent maintains bile duct patency and is left in place until cholecystectomy.

Prophylactic Biliary Stenting Group

Endoscopic Retrograde Cholangiopancreatography with Stone Clearance PROCEDURE

Standard endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic sphincterotomy and complete choledocholithiasis clearance documented on occlusion cholangiogram. No temporary biliary stent is placed.

No Stenting Group; Prophylactic Biliary Stenting Group

Eligibility Criteria

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

You may qualify if:

• Age 18 to 75 years at the time of enrollment
• Diagnosis of concomitant cholelithiasis and choledocholithiasis
• Successful ERCP with complete choledocholithiasis clearance documented on occlusion cholangiogram during the index procedure
• Endoscopic sphincterotomy (EST) performed during ERCP
• Ability to provide informed consent
• Scheduled for laparoscopic cholecystectomy within 2-4 weeks of ERCP
• No contraindications to cholecystectomy

You may not qualify if:

• Incomplete choledocholithiasis clearance (residual stones on occlusion cholangiogram)
• Altered biliary anatomy (e.g., previous bilioenteric anastomosis, Roux-en-Y reconstruction)
• Active cholangitis or sepsis at the time of ERCP
• Immunocompromised status (HIV/AIDS, active chemotherapy, chronic corticosteroid use)
• Coagulopathy or anticoagulation therapy that cannot be safely interrupted
• Pregnancy or lactation
• Severe cardiopulmonary disease precluding safe anesthesia
• Contraindications to cholecystectomy (e.g., unresectable malignancy, severe cirrhosis with portal hypertension)
• Participation in another clinical trial within the past 30 days
• Unable or unwilling to comply with follow-up protocol

Sponsors & Collaborators

• National Liver Institute, Egypt: lead

Study Sites (1)

National Liver Institute, Menoufia University, Egypt.

Shibīn al Kawm, 32511, Egypt

Location

Related Publications (4)

• Zhu J, Li G, Du P, Zhou X, Xiao W, Li Y. Laparoscopic common bile duct exploration versus intraoperative endoscopic retrograde cholangiopancreatography in patients with gallbladder and common bile duct stones: a meta-analysis. Surg Endosc. 2021 Mar;35(3):997-1005. doi: 10.1007/s00464-020-08052-y. Epub 2020 Oct 6.

  PMID: 33025251 BACKGROUND

• Chaudhary S. Epidemiology of gall stone diseases among patients attending surgical department of a tertiary care hospital in Nepal. Janaki Med. Coll. J.Med. Sci., 2020; 8(1), 50-55.

  BACKGROUND

• Cai H, Sun D, Sun Y, Bai J, Zhao H, Miao Y. Primary closure following laparoscopic common bile duct exploration combined with intraoperative cholangiography and choledochoscopy. World J Surg. 2012 Jan;36(1):164-70. doi: 10.1007/s00268-011-1346-6.

  PMID: 22086256 BACKGROUND

• Abd El Wahab AE, Khalil OO. Comparative study between primary common bile duct repair with internal stent insertion versus t-tube drainage after common bile duct exploration. Al-Azhar Intern. Med. J., 2022; 3(1), 107-111.

  BACKGROUND

MeSH Terms

Conditions

Choledocholithiasis; Cholelithiasis

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

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

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 9, 2026
• Study Start: March 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 9, 2026

Record last verified: 2025-12

Locations

EG (1)