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
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