NCT07413068

Treatment Outcomes and Complications of Three Therapeutic Approaches for Concomitant Choledocholithiasis and Cholecystolithiasis

Comparative Study of ERCP, ERCP Plus Laparoscopic Cholecystectomy, and Conservative Management in Patients With Concomitant Choledocholithiasis and Cholecystolithiasis.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Recruit patients with cholelithiasis with concomitant choledocholithiasis into the cohort, and assign them to undergo endoscopic transpapillary gallbladder-preserving cholecystolithotomy or ERCP plus laparoscopic cholecystectomy or conservative treatment based on patient preference. Collect clinical data and patient-reported outcomes regularly at baseline and during follow-up in the cohort. Assess the clinical safety of ERCP-GPC and LC by evaluating the clinical success rate of treatment as well as the incidence of short-term and long-term postoperative complications; investigate the efficacy differences among endoscopic transpapillary gallbladder-preserving cholecystolithotomy or ERCP plus laparoscopic cholecystectomy or conservative treatment in managing cholelithiasis with concomitant choledocholithiasis.

Conditions

• Cholelithiasis Associated With Common Bile Duct Stones

Interventions

Type	Name	Description
PROCEDURE	endoscopic transpapillary gallbladder-preserving	Based on the patient's preference, they will receive the following treatment：endoscopic transpapillary gallbladder-preserving
PROCEDURE	ERCP plus Laparoscopic Cholecystectomy	Based on the patient's preference, they will receive the following treatment：ERCP plus Laparoscopic Cholecystectomy
DRUG	Conservative treatment	Based on the patient's preference, they will receive the following treatment：ursodeoxycholic acid for stone dissolution,ESWL or symptomatic and supportive care.

Timeline

• Start date: 2025-12-01
• Primary completion: 2030-12-01
• Completion: 2030-12-01
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: China