Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT04672902
Status:
COMPLETED
Last Update Posted:
2020-12-17
First Post:
2020-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Mirizzi Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057792', 'term': 'Mirizzi Syndrome'}, {'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D041881', 'term': 'Cholecystitis, Acute'}], 'ancestors': [{'id': 'D002779', 'term': 'Cholestasis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002764', 'term': 'Cholecystitis'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-15', 'studyFirstSubmitDate': '2020-12-09', 'studyFirstSubmitQcDate': '2020-12-15', 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resolution of the common bile duct compression by an extrinsic gallbladder stone, with minimally invasive procedure such as single operator cholangioscopy, combined with lithotripsy', 'timeFrame': '2019-2020', 'description': 'Single operator cholangioscopy, combined with lithotripsy, will be use for treating patients with Mirizzi syndrome, while avoiding open surgery, and subsequent lesions to the biliary ducts. Post surgical morbidity will be assessed.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mirizzi Syndrome', 'Cholelithiasis', 'Acute Cholecystitis']}, 'descriptionModule': {'briefSummary': "Mirizzi syndrome is an infrequent complication of long-standing cholelithiasis. Extrinsic compression of the common hepatic duct is usually caused by an impacted stone in Hartmann's pouch or cystic duct resulting in the development of cholecystobiliary fistula. This syndrome is classified based on the presence and severity of cholecystobiliary fistula. Mirizzi syndrome is challenging to diagnose preoperatively and may require complex biliary surgical procedures for resolution. Endoscopic treatment is a safe alternative with a high success rate. Single-operator cholangioscopy combined with lithotripsy has been shown to have a 90-100% success rate in the treatment of biliary stones. Herein, A single center experience treating Mirizzi syndrome with single-operator cholangioscopy guided electrohydraulic lithotripsy is presented. Difficult management of Mirizzi syndrome has led to research of new treatment options to minimize the risk of high rate complications. Single-operator cholangioscopy in combination with laser lithotripsy is an adequate and safe alternative for the treatment of this condition."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A 34-year-old female, A 54-year-old male, A 40-year-old female. with diagnosed Mirizzi Syndrome by an image study, with a concomitant common bile duct dilatation.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years old\n* Patients with a preoperative diagnosis of Mirizzi Syndrome\n* Patients with a common bile duct dilatation\n\nExclusion Criteria:\n\n* Patients younger than 18 years old\n* Patients with an inconclusive biliary diagnosis\n* Patients without a diagnosis of Mirrizi Syndrome\n* Patients without common bile duct dilatation'}, 'identificationModule': {'nctId': 'NCT04672902', 'briefTitle': 'Treatment of Mirizzi Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Tecnologico de Monterrey'}, 'officialTitle': 'Single-operator Cholangioscopy and Electrohydraulic Lithotripsy for the Treatment of Mirizzi Syndrome: A Case Series', 'orgStudyIdInfo': {'id': 'MS2012'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Single-operator cholangioscopy guided electrohydraulic lithotripsy', 'type': 'PROCEDURE', 'description': 'Single-operator cholangioscopy guided electrohydraulic lithotripsy has the advantage of providing direct visualization of the bile ducts, enabling a single physician to diagnose and perform the therapeutic intervention in a single procedure.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '76140', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Escuela Nacional de Medicina, Tecnologico de Monterrey', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tecnologico de Monterrey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}