Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-28 @ 4:36 PM
Study NCT ID:
NCT05186350
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2022-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SpyGlass Versus ESWL for Large Common Bile Duct Stones
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D042883', 'term': 'Choledocholithiasis'}, {'id': 'D042882', 'term': 'Gallstones'}], 'ancestors': [{'id': 'D003137', 'term': 'Common Bile Duct Diseases'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D041761', 'term': 'Cholecystolithiasis'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-18', 'studyFirstSubmitDate': '2022-01-06', 'studyFirstSubmitQcDate': '2022-01-10', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clearance rate(percentage)', 'timeFrame': '1 month', 'description': 'Stone clearance ratio'}, {'measure': 'Number of sessions', 'timeFrame': '1 month', 'description': 'Number of ERCP procedures'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': '1 month', 'description': 'Side effect of the procedures'}, {'measure': 'Procedure Time', 'timeFrame': 'Intraoperative', 'description': 'Time spent for each surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Choledocholithiasis; SpyGlass; ESWL;ERCP'], 'conditions': ['Choledocholithiasis', 'Common Bile Duct Calculi']}, 'referencesModule': {'references': [{'pmid': '28785149', 'type': 'BACKGROUND', 'citation': 'Tao T, Zhang M, Zhang QJ, Li L, Li T, Zhu X, Li MD, Li GH, Sun SX. Outcome of a session of extracorporeal shock wave lithotripsy before endoscopic retrograde cholangiopancreatography for problematic and large common bile duct stones. World J Gastroenterol. 2017 Jul 21;23(27):4950-4957. doi: 10.3748/wjg.v23.i27.4950.'}, {'pmid': '31557778', 'type': 'BACKGROUND', 'citation': '[French comment on article Cholangioscopy-guided lithotripsy for difficult bile duct stone clearance in a single session of ERCP: results from a large multinational registry demonstrate high success rates]. Endoscopy. 2019 Oct;51(10):1006-1007. doi: 10.1055/a-1000-5911. Epub 2019 Sep 26. No abstract available. French.'}, {'pmid': '30943551', 'type': 'BACKGROUND', 'citation': 'Manes G, Paspatis G, Aabakken L, Anderloni A, Arvanitakis M, Ah-Soune P, Barthet M, Domagk D, Dumonceau JM, Gigot JF, Hritz I, Karamanolis G, Laghi A, Mariani A, Paraskeva K, Pohl J, Ponchon T, Swahn F, Ter Steege RWF, Tringali A, Vezakis A, Williams EJ, van Hooft JE. Endoscopic management of common bile duct stones: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2019 May;51(5):472-491. doi: 10.1055/a-0862-0346. Epub 2019 Apr 3.'}, {'pmid': '40811584', 'type': 'DERIVED', 'citation': 'Khizar H, Gu W, Zhou H, Yang J, Jin H, He X, Zhang X, Yang J. A comparative study of extracorporeal shock wave lithotripsy and cholangioscopy-guided lithotripsy in the management of complex biliary stones: A randomized trial. J Trauma Acute Care Surg. 2025 Oct 1;99(4):628-634. doi: 10.1097/TA.0000000000004693. Epub 2025 Aug 13.'}]}, 'descriptionModule': {'briefSummary': 'Overall stone clearance with endoscopic retrograde cholangiopancreatography (ERCP) for choledocholithiasis is a big problem, especially for stones with a diameter greater than 3cm. After ERCP failure, surgery was the option but patients not suitable for surgery were treated through stenting but had to undergo multiple ERCPs and show a success rate of only 44-96%. Recently, choledochoscopic laser, electrohydraulic lithotripsy, SpyGlass, or extracorporeal shock wave lithotripsy (ESWL) have been applied for the treatment of huge bile duct stones. The present study aims to compare the efficacy and safety outcomes of SpyGlass direct vision lithotripsy and ESWL procedures for the removal of large bile duct stones.', 'detailedDescription': 'ESWL was first used for the removal of renal calculi and ureteral calculi however, now a day is being used for biliary calculi. It has the advantages of simple operation, low cost, and higher safety. Recent studies show that the procedure time for ESWL is also shorter and the utilization rate of mechanical lithotripsy was effectively reduced with fewer complications. But It is difficult for ESWL to break the stones larger than 3cm into small pieces. So SpyGlass-guided laser lithotripsy is used. Spyglass has been used in clinics for more than ten years. Recently, a study reported difficult bile duct stones that were treated with SpyGlass-guided laser lithotripsy that shows promising results. Compared with laser lithotripsy under X-ray monitoring, there is no significant difference in stone removal rate and complication rate between the two methods. However, the effect of lithotripsy under Spyglass direct vision is better, which can break large stones into smaller pieces, thus making it easier to take stones. The investigators conducted the current study to compare the therapeutic outcome and complications between SpyGlass direct vision lithotripsy and ESWL procedures for the removal of large bile duct stones'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* large bile duct stones (≥10 mm)\n\nExclusion Criteria:\n\n* pregnancy\n* refusal of written informed consent\n* Patients with benign or malignant biliary stricture\n* Contraindications to ERCP exist\n* Complicated with acute pancreatitis or acute cholangitis\n* Coagulation dysfunction#thrombocytopenia\n* Patients after gastrointestinal reconstruction'}, 'identificationModule': {'nctId': 'NCT05186350', 'briefTitle': 'SpyGlass Versus ESWL for Large Common Bile Duct Stones', 'organization': {'class': 'OTHER', 'fullName': "First People's Hospital of Hangzhou"}, 'officialTitle': 'Comparison of SpyGlass Guided Lithotripsy Versus Extracorporeal Shockwaves Lithotripsy for Large Common Bile Duct Stones', 'orgStudyIdInfo': {'id': '2022-01-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SpyGlass group', 'description': 'ERCP plus SpyGlass group', 'interventionNames': ['Procedure: ERCP+ SpyGlass']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ESWL group', 'description': 'ERCP plus ESWL', 'interventionNames': ['Procedure: ESWL+ ERCP']}], 'interventions': [{'name': 'ERCP+ SpyGlass', 'type': 'PROCEDURE', 'description': 'SpyGlass direct Vision guided laser lithotripsy', 'armGroupLabels': ['SpyGlass group']}, {'name': 'ESWL+ ERCP', 'type': 'PROCEDURE', 'description': 'ESWL + Stone removal through ERCP', 'armGroupLabels': ['ESWL group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31006', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "Hangzhou First People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Jianfeng Yang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affilated Hangzhou First People Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First People's Hospital of Hangzhou", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jianfeng Yang', 'investigatorAffiliation': "First People's Hospital of Hangzhou"}}}}