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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorQilu Hospital of Shandong University

About this trial

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.

Eligibility criteria

Qualifiers

Patients over the age of 18 years;

Ultrasound, MRCP, or other imaging examination findings (CT/MRI) clearly indicate a diagnosis of cholelithiasis with concomitant choledocholithiasis;

Patients with no history of gastrointestinal reconstruction surgery or cholecystectomy or previous biliary tract surgery (include history of ERCP);

Patients with every gallbladder stone ≤1 cm in diameter or sludge-like stones;

Disqualifiers

Atrophic cholecystitis; porcelain gallbladder; suspect malignant tumor of the gallbladder; stenosis of the lower segment of the common bile duct; Mirrizzi syndrome;

Unable to undergo endoscopic interventions for various reasons;

Absolute surgical contraindications, including severe hepatic, renal, cardiac and pulmonary insufficiency, history of cerebral coma and allergy to anesthesia, etc;

Presence of ectopic duodenal papilla or congenital pancreaticobiliary malformation;

Trial design

Treatments tested in this trial

  • endoscopic transpapillary gallbladder-preserving
  • ERCP plus Laparoscopic Cholecystectomy
  • Conservative treatment

Treatment groups

300 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Qilu Hospital of Shandong University

Lead sponsor

The Affiliated Hospital of Qingdao University

Collaborator

Shandong Province Third hospital

Collaborator

Qingdao Municipal Hospital

Collaborator

Shengli Oilfield Hospital

Collaborator

Liaocheng People's Hospital

Collaborator

Binzhou Medical University

Collaborator

Weifang People's Hospital

Collaborator

Taian City Central Hospital

Collaborator

Qianfoshan Hospital

Collaborator

Linyi People's Hospital

Collaborator

Qilu Hospital of Shandong University (Qingdao)

Collaborator

Central Hospital of Zibo

Collaborator

The Second Hospital of Shandong University

Collaborator

Dezhou Hospital Qilu Hospital of Shandong University

Collaborator

Rizhao People's Hospital

Collaborator