Qilu Hospital of Shandong University
Jinan, Shandong, 250063, China
Location status: Recruiting
NCT Number: NCT07413068
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Jinan, Shandong, 250063, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Based on the patient's preference, they will receive the following treatment:endoscopic transpapillary gallbladder-preserving
Based on the patient's preference, they will receive the following treatment:ERCP plus Laparoscopic Cholecystectomy
Based on the patient's preference, they will receive the following treatment:ursodeoxycholic acid for stone dissolution,ESWL or symptomatic and supportive care.
Other names: Conservative treatment group
Time frame: From enrollment to 3 years after the end of treatment
Compare the rates of intraoperative, early, and late postoperative complications include bile duct injury and recurrence of bile duct stones,etc.
Time frame: From enrollment to 3 years after the end of treatment
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.
Time frame: From enrollment to 3 years after the end of 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.
Contact information is provided by the study sponsor or research team.
Qilu Hospital of Shandong University
Other
Comparative Study of ERCP, ERCP Plus Laparoscopic Cholecystectomy, and Conservative Management in Patients With Concomitant Choledocholithiasis and Cholecystolithiasis.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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