[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624702":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":20,"studyPopulation":24,"armGroups":25,"interventions":41,"overallOfficials":57,"centralContacts":61,"locations":67,"responsibleParty":81,"collaborators":83,"id":114,"slug":20,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":20,"eligibilityCriteria":119,"healthyVolunteers":115,"sex":120,"minAge":121,"maxAge":20,"enrollmentInfo":122,"targetDuration":125,"studyType":126,"phases":20,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":69,"whyStopped":20,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Qilu Hospital of Shandong University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"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.","From enrollment to 3 years after the end of treatment",[14,17],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":12},"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 \u002F duration of hospitalization (Unit: \\[e.g., CNY\u002FUSD\\] per day).It can reflect the average daily inpatient economic cost for each treatment, enabling integrated comparison of economic efficiency across the three groups.",null,{"allocation":20,"interventionModel":20,"interventionModelDescription":20,"primaryPurpose":20,"observationalModel":22,"timePerspective":23,"maskingInfo":20},"COHORT","PROSPECTIVE","patients with cholelithiasis with concomitant choledocholithiasis",[26,31,36],{"label":27,"type":20,"description":28,"interventionNames":29},"Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy","The patients intend to receive Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy",[30],"Procedure: endoscopic transpapillary gallbladder-preserving",{"label":32,"type":20,"description":33,"interventionNames":34},"ERCP plus Laparoscopic Cholecystectomy","The patients intend to receive ERCP plus laparoscopic cholecystectomy",[35],"Procedure: ERCP plus Laparoscopic Cholecystectomy",{"label":37,"type":20,"description":38,"interventionNames":39},"Conservative Treatment","After removal of common bile duct stone via ERCP,neither ERCP nor laparoscopic cholecystectomy will be carried out to treat cholecystolithiasis.",[40],"Drug: Conservative treatment",[42,47,50],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":20},"PROCEDURE","endoscopic transpapillary gallbladder-preserving","Based on the patient's preference, they will receive the following treatment：endoscopic transpapillary gallbladder-preserving",[27],{"type":43,"name":32,"description":48,"armGroupLabels":49,"otherNames":20},"Based on the patient's preference, they will receive the following treatment：ERCP plus Laparoscopic Cholecystectomy",[32],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"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.",[37],[56],"Conservative treatment group",[58],{"name":59,"affiliation":5,"role":60},"Tao Yu, MD","PRINCIPAL_INVESTIGATOR",[62],{"name":63,"role":64,"phone":65,"phoneExt":20,"email":66},"Zhen Li, MD","CONTACT","18560086106","qilulizhen@sdu.edu.cn",[68],{"facility":5,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":20},"RECRUITING","Jinan","Shandong","250063","China","CN",{"type":76,"coordinates":77},"Point",[78,79],116.99722,36.66833,{"lat":79,"lon":78},{"type":82,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[84,86,88,90,92,94,96,98,100,102,104,106,108,110,112],{"name":85,"class":6},"The Affiliated Hospital of Qingdao University",{"name":87,"class":6},"Shandong Province Third hospital",{"name":89,"class":6},"Qingdao Municipal Hospital",{"name":91,"class":6},"Shengli Oilfield Hospital",{"name":93,"class":6},"Liaocheng People's Hospital",{"name":95,"class":6},"Binzhou Medical University",{"name":97,"class":6},"Weifang People's Hospital",{"name":99,"class":6},"Taian City Central Hospital",{"name":101,"class":6},"Qianfoshan Hospital",{"name":103,"class":6},"Linyi People's Hospital",{"name":105,"class":6},"Qilu Hospital of Shandong University (Qingdao)",{"name":107,"class":6},"Central Hospital of Zibo",{"name":109,"class":6},"The Second Hospital of Shandong University",{"name":111,"class":6},"Dezhou Hospital Qilu Hospital of Shandong University",{"name":113,"class":6},"Rizhao People's Hospital","100624702",false,"NCT07413068","Treatment Outcomes and Complications of Three Therapeutic Approaches for Concomitant Choledocholithiasis and Cholecystolithiasis","Comparative Study of ERCP, ERCP Plus Laparoscopic Cholecystectomy, and Conservative Management in Patients With Concomitant Choledocholithiasis and Cholecystolithiasis.","Inclusion Criteria\n\n1. Patients over the age of 18 years;\n2. Ultrasound, MRCP, or other imaging examination findings (CT\u002FMRI) clearly indicate a diagnosis of cholelithiasis with concomitant choledocholithiasis;\n3. Patients with no history of gastrointestinal reconstruction surgery or cholecystectomy or previous biliary tract surgery (include history of ERCP);\n4. Patients with every gallbladder stone ≤1 cm in diameter or sludge-like stones;\n5. The morphology and size of the gallbladder are essentially normal and the thickness of the gallbladder wall is ≤3 mm;\n6. Voluntary provision of signed informed consent.\n\nExclusion Criteria\n\n1. Atrophic cholecystitis; porcelain gallbladder; suspect malignant tumor of the gallbladder; stenosis of the lower segment of the common bile duct; Mirrizzi syndrome;\n2. Unable to undergo endoscopic interventions for various reasons;\n3. Absolute surgical contraindications, including severe hepatic, renal, cardiac and pulmonary insufficiency, history of cerebral coma and allergy to anesthesia, etc;\n4. Presence of ectopic duodenal papilla or congenital pancreaticobiliary malformation;\n5. Patients with severe coagulopathy, defined as an International Normalized Ratio (INR) \\> 1.5 or patients with significant thrombocytopenia (platelet count \\\u003C 50 × 10⁹\u002FL);\n6. Pregnant women;","ALL","18 Years",{"count":123,"type":124},300,"ESTIMATED","36 Months","OBSERVATIONAL","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.",[129],"Cholelithiasis Associated With Common Bile Duct Stones",[131,27,32,52],"Cholelithiasis with Concomitant Choledocholithiasis","2026-05-14",{"date":134,"type":135},"2026-05-18","ACTUAL",{"date":137,"type":135},"2025-12-01",{"date":139,"type":124},"2030-12",{"name":5,"class":6},1]