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

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

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.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Shandong Province Third hospital

  collaborator OTHER

• Qingdao Municipal Hospital

  collaborator OTHER

• Shengli Oilfield Hospital

  collaborator OTHER

• Liaocheng People's Hospital

  collaborator OTHER

• Binzhou Medical University

  collaborator OTHER

• Weifang People's Hospital

  collaborator OTHER

• Taian City Central Hospital

  collaborator OTHER

• Qianfoshan Hospital

  collaborator OTHER

• Linyi People's Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University (Qingdao)

  collaborator OTHER

• Central Hospital of Zibo

  collaborator OTHER

• The Second Hospital of Shandong University

  collaborator OTHER

• Dezhou Hospital Qilu Hospital of Shandong University

  collaborator OTHER

• Rizhao People's Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University

  lead OTHER

Principal Investigators

• Tao Yu, MD · Qilu Hospital of Shandong University

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-01

Primary Completion

2030-12-31

Completion

2030-12-31

Countries

• China

Study Locations