Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 12:26 AM
Study NCT ID:
NCT07413068
Status:
RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment Outcomes and Complications of Three Therapeutic Approaches for Concomitant Choledocholithiasis and Cholecystolithiasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002760', 'term': 'Cholangiopancreatography, Endoscopic Retrograde'}, {'id': 'D017081', 'term': 'Cholecystectomy, Laparoscopic'}, {'id': 'D000072700', 'term': 'Conservative Treatment'}], 'ancestors': [{'id': 'D002758', 'term': 'Cholangiography'}, {'id': 'D011860', 'term': 'Radiography, Abdominal'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D002763', 'term': 'Cholecystectomy'}, {'id': 'D001662', 'term': 'Biliary Tract Surgical Procedures'}, {'id': 'D010535', 'term': 'Laparoscopy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '36 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2026-01-14', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the clinical safety of ERCP-GPC ,LC and conservative treatments by evaluating the incidence of intraoperative,short-term and long-term postoperative complications.', 'timeFrame': 'From enrollment to 3 years after the end of treatment', 'description': 'Compare the rates of intraoperative, early, and late postoperative complications include bile duct injury and recurrence of bile duct stones,etc.'}], 'secondaryOutcomes': [{'measure': 'Investigate the differences in efficacy among endoscopic transpapillary gallbladder-preserving cholecystolithotomy , ERCP plus laparoscopic cholecystectomy and conservative treament in managing cholelithiasis with concomitant choledocholithiasis.', 'timeFrame': 'From enrollment to 3 years after the end of treatment', 'description': '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': 'Conduct a comparative analysis of the economic efficiency of ERCP-GPC , LC and conservative treatment.', 'timeFrame': 'From enrollment to 3 years after the end of treatment', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cholelithiasis with Concomitant Choledocholithiasis', 'Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy', 'ERCP plus Laparoscopic Cholecystectomy', 'Conservative treatment'], 'conditions': ['Cholelithiasis Associated With Common Bile Duct Stones']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with cholelithiasis with concomitant choledocholithiasis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Patients over the age of 18 years;\n2. Ultrasound, MRCP, or other imaging examination findings (CT/MRI) 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 \\< 50 × 10⁹/L);\n6. Pregnant women;'}, 'identificationModule': {'nctId': 'NCT07413068', 'briefTitle': 'Treatment Outcomes and Complications of Three Therapeutic Approaches for Concomitant Choledocholithiasis and Cholecystolithiasis', 'organization': {'class': 'OTHER', 'fullName': 'Qilu Hospital of Shandong University'}, 'officialTitle': 'Comparative Study of ERCP, ERCP Plus Laparoscopic Cholecystectomy, and Conservative Management in Patients With Concomitant Choledocholithiasis and Cholecystolithiasis.', 'orgStudyIdInfo': {'id': '2025SDU-QILU-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy', 'description': 'The patients intend to receive Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy', 'interventionNames': ['Procedure: endoscopic transpapillary gallbladder-preserving']}, {'label': 'ERCP plus Laparoscopic Cholecystectomy', 'description': 'The patients intend to receive ERCP plus laparoscopic cholecystectomy', 'interventionNames': ['Procedure: ERCP plus Laparoscopic Cholecystectomy']}, {'label': 'Conservative Treatment', 'description': 'After removal of common bile duct stone via ERCP,neither ERCP nor laparoscopic cholecystectomy will be carried out to treat cholecystolithiasis.', 'interventionNames': ['Drug: Conservative treatment']}], 'interventions': [{'name': 'endoscopic transpapillary gallbladder-preserving', 'type': 'PROCEDURE', 'description': "Based on the patient's preference, they will receive the following treatment：endoscopic transpapillary gallbladder-preserving", 'armGroupLabels': ['Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy']}, {'name': 'ERCP plus Laparoscopic Cholecystectomy', 'type': 'PROCEDURE', 'description': "Based on the patient's preference, they will receive the following treatment：ERCP plus Laparoscopic Cholecystectomy", 'armGroupLabels': ['ERCP plus Laparoscopic Cholecystectomy']}, {'name': 'Conservative treatment', 'type': 'DRUG', 'otherNames': ['Conservative treatment group'], 'description': "Based on the patient's preference, they will receive the following treatment：ursodeoxycholic acid for stone dissolution,ESWL or symptomatic and supportive care.", 'armGroupLabels': ['Conservative Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250063', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Zhen Li, MD', 'role': 'CONTACT', 'email': 'qilulizhen@sdu.edu.cn', 'phone': '18560086106'}], 'overallOfficials': [{'name': 'Tao Yu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qilu Hospital of Shandong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Affiliated Hospital of Qingdao University', 'class': 'OTHER'}, {'name': 'Shandong Province Third hospital', 'class': 'OTHER'}, {'name': 'Qingdao Municipal Hospital', 'class': 'OTHER'}, {'name': 'Shengli Oilfield Hospital', 'class': 'OTHER'}, {'name': "Liaocheng People's Hospital", 'class': 'OTHER'}, {'name': 'Binzhou Medical University', 'class': 'OTHER'}, {'name': "Weifang People's Hospital", 'class': 'OTHER'}, {'name': 'Taian City Central Hospital', 'class': 'OTHER'}, {'name': 'Qianfoshan Hospital', 'class': 'OTHER'}, {'name': "Linyi People's Hospital", 'class': 'OTHER'}, {'name': 'Qilu Hospital of Shandong University (Qingdao)', 'class': 'OTHER'}, {'name': 'Central Hospital of Zibo', 'class': 'OTHER'}, {'name': 'The Second Hospital of Shandong University', 'class': 'OTHER'}, {'name': 'Dezhou Hospital Qilu Hospital of Shandong University', 'class': 'OTHER'}, {'name': "Rizhao People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}