CBD Stenting vs Non-Stenting for Choledocholithiasis

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.

Inclusion criteria

• 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

Exclusion criteria

• 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