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.
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;
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;
patients with cholelithiasis with concomitant choledocholithiasis
Cohort
Prospective
endoscopic transpapillary gallbladder-preserving
Procedure/SurgeryBased on the patient's preference, they will receive the following treatment：endoscopic transpapillary gallbladder-preserving
ERCP plus Laparoscopic Cholecystectomy
Procedure/SurgeryBased on the patient's preference, they will receive the following treatment：ERCP plus Laparoscopic Cholecystectomy
Conservative treatment
DrugBased on the patient's preference, they will receive the following treatment：ursodeoxycholic acid for stone dissolution,ESWL or symptomatic and supportive care.
Assess the clinical safety of ERCP-GPC ,LC and conservative treatments by evaluating the incidence of intraoperative,short-term and long-term postoperative complications.
Compare the rates of intraoperative, early, and late postoperative complications include bile duct injury and recurrence of bile duct stones,etc.
Investigate the differences in efficacy among endoscopic transpapillary gallbladder-preserving cholecystolithotomy , ERCP plus laparoscopic cholecystectomy and conservative treament in managing cholelithiasis with concomitant choledocholithiasis.
Compare the gallbladder stone clearance rate and bile duct stone clearance rate among the three groups; meanwhile, record the rates of successful gallbladder access establishment via FCMS and successful guidewire cannulation into the gallbladder in the gallbladder-preserving cholecystolithotomy group, so as to clarify the clinical success rate and technical success rate of this technique.
Conduct a comparative analysis of the economic efficiency of ERCP-GPC , LC and conservative treatment.
Record duration of Hospitalization and total Medical Expenses of the three groups then calculate them as total medical expenses / duration of hospitalization (Unit: \[e.g., CNY/USD\] per day).It can reflect the average daily inpatient economic cost for each treatment, enabling integrated comparison of economic efficiency across the three groups.
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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
