An interventional study of Temporary Plastic Biliary Stent Placement and Endoscopic Retrograde Cholangiopancreatography with Stone Clearance in Choledocholithiasis, sponsored by National Liver Institute, Egypt. Completed at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by National Liver Institute, Egypt · Not applicable, Interventional, and Treatment
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.
BACKGROUND AND RATIONALE:
Choledocholithiasis frequently coexists with cholelithiasis and is typically managed through a two-stage approach: endoscopic retrograde cholangiopancreatography (ERCP) for stone clearance, followed by laparoscopic cholecystectomy to remove the source of stone formation. The timing and sequencing of these procedures, as well as the role of temporary protective measures during the interval between ERCP and cholecystectomy, have been subjects of clinical debate.
Prophylactic biliary stenting after complete stone clearance has been suggested as a potential protective measure to maintain bile duct patency and prevent recurrent stone migration during the waiting period before cholecystectomy. The theoretical advantages include prevention of stent-related complications such as post-ERCP pancreatitis, maintenance of adequate bile drainage, and reduction in recurrent biliary events. However, the actual clinical benefit of this practice has not been definitively established, and temporary stents themselves carry risks including stent occlusion, migration, and infection.
STUDY OBJECTIVES:
Primary Objective: To determine whether prophylactic biliary stent placement after documented complete choledocholithiasis clearance reduces the recurrence of choledocholithiasis in patients awaiting cholecystectomy.
Secondary Objectives: To compare the incidence of biliary complications (cholecystitis, post-ERCP pancreatitis, cholangitis) between the stenting and no-stenting groups, to assess the need for repeat or emergency ERCP during the follow-up period, to evaluate stent-related complications in the stenting group, and to compare radiation exposure metrics, and cost-effectiveness.
STUDY DESIGN:
This is a prospective, randomized controlled trial with parallel assignment comparing prophylactic biliary stenting versus no stenting in patients with complete choledocholithiasis clearance awaiting cholecystectomy. The study is open-label, with outcome assessors blinded to treatment allocation.
STUDY POPULATION:
The study includes adult patients (age 18-75 years) with concomitant cholelithiasis and choledocholithiasis who have undergone successful ERCP with complete stone clearance documented on occlusion cholangiogram. Patients are excluded if they have incomplete stone clearance, altered anatomy precluding stent placement, active cholangitis, immunocompromised status, or contraindications to cholecystectomy.
RANDOMIZATION AND ALLOCATION:
Participants are randomized 1:1 to either the stenting group or the no-stenting group using a computer-generated randomization sequence with permuted blocks. Randomization is stratified by study site to ensure balanced allocation across participating centers. Allocation concealment is maintained through sealed, opaque envelopes.
INTERVENTIONS:
Stenting Group: Following successful ERCP with complete choledocholithiasis clearance (documented on occlusion cholangiogram), a temporary plastic biliary stent (7-10 French) is placed across the sphincter of Oddi to maintain bile duct patency until cholecystectomy.
No-Stenting Group: Patients undergo ERCP with complete choledocholithiasis clearance without placement of a temporary biliary stent and proceed directly to cholecystectomy.
FOLLOW-UP PROCEDURES:
All participants are scheduled for laparoscopic cholecystectomy within 2-4 weeks of ERCP. Clinical assessments are performed at baseline (ERCP), week 1, pre-cholecystectomy (week 2-4), and at 1 month and 3 months post-ERCP. Imaging studies (ultrasound or CT) are performed at baseline and at the 3-month follow-up to assess for stone recurrence.
OUTCOME MEASURES:
Primary Outcome: Recurrence of choledocholithiasis documented on imaging or endoscopy during the 3-month follow-up period.
Secondary Outcomes: Incidence of biliary complications (cholecystitis, post-ERCP pancreatitis, cholangitis); need for repeat or emergency ERCP; stent-related complications; hospital readmission rates; time to cholecystectomy.
STATISTICAL ANALYSIS:
The primary analysis compares the recurrence rate between the two groups using chi-square test or Fisher's exact test. Secondary outcomes are compared using appropriate statistical tests. Intention-to-treat analysis is performed, including all randomized participants in their assigned groups.
109 studies on the registry are indexed under Choledocholithiasis; 24 are open to participants now.
This study's enrollment of 200 is above the median of 100 across 76 interventional studies indexed under Choledocholithiasis.
Browse Choledocholithiasis studies →National Liver Institute, Egypt is the lead sponsor of 18 studies on the registry; 1 is open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Immunosuppression
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HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Cancer (malignancy)
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Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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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
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
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.
Standard endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic sphincterotomy and complete choledocholithiasis clearance documented on occlusion cholangiogram. No temporary biliary stent is placed.
Recurrence of Choledocholithiasis
Radiological or endoscopic evidence of recurrent common bile duct stones documented on imaging (ultrasound, CT, MRCP) or during repeat endoscopy.
Time frame: 3 months after initial ERCP
Biliary Complications
Incidence of post-ERCP pancreatitis, cholecystitis, cholangitis, or other biliary-related adverse events.
Time frame: 3 months after initial ERCP
Plan to share: Undecided
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National Liver Institute, Egypt