Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:40 PM
Study NCT ID:
NCT05556434
Status:
UNKNOWN
Last Update Posted:
2023-09-13
First Post:
2022-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predicting Complications of Hepatolithiasis After Hepatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2011-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-11', 'studyFirstSubmitDate': '2022-09-23', 'studyFirstSubmitQcDate': '2022-09-23', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complications', 'timeFrame': '3 months', 'description': 'Postoperative complications and mortality are recorded according to the Clavien-Dindo classification system'}], 'secondaryOutcomes': [{'measure': 'Recurrence of hepatolithiasis', 'timeFrame': '1 year', 'description': 'Patients were followed-up at an interval of 3 months and recurrence of hepatolithiasis is evaluated by radiological methods.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['liver resection', 'complication', 'risk factor', 'machine learning', 'hepatolithiasis'], 'conditions': ['Liver Diseases', 'Complication']}, 'referencesModule': {'references': [{'pmid': '20032719', 'type': 'BACKGROUND', 'citation': 'Yang T, Lau WY, Lai EC, Yang LQ, Zhang J, Yang GS, Lu JH, Wu MC. Hepatectomy for bilateral primary hepatolithiasis: a cohort study. Ann Surg. 2010 Jan;251(1):84-90. doi: 10.1097/SLA.0b013e3181b2f374.'}, {'pmid': '9240138', 'type': 'BACKGROUND', 'citation': "Su CH, Shyr YM, Lui WY, P'Eng FK. Hepatolithiasis associated with cholangiocarcinoma. Br J Surg. 1997 Jul;84(7):969-73. doi: 10.1002/bjs.1800840717."}, {'pmid': '22921329', 'type': 'BACKGROUND', 'citation': 'Tabrizian P, Jibara G, Shrager B, Schwartz ME, Roayaie S. Hepatic resection for primary hepatolithiasis: a single-center Western experience. J Am Coll Surg. 2012 Nov;215(5):622-6. doi: 10.1016/j.jamcollsurg.2012.07.005. Epub 2012 Aug 24.'}, {'pmid': '27248425', 'type': 'BACKGROUND', 'citation': 'Citterio D, Facciorusso A, Sposito C, Rota R, Bhoori S, Mazzaferro V. Hierarchic Interaction of Factors Associated With Liver Decompensation After Resection for Hepatocellular Carcinoma. JAMA Surg. 2016 Sep 1;151(9):846-53. doi: 10.1001/jamasurg.2016.1121.'}, {'pmid': '12368667', 'type': 'BACKGROUND', 'citation': 'Jarnagin WR, Gonen M, Fong Y, DeMatteo RP, Ben-Porat L, Little S, Corvera C, Weber S, Blumgart LH. Improvement in perioperative outcome after hepatic resection: analysis of 1,803 consecutive cases over the past decade. Ann Surg. 2002 Oct;236(4):397-406; discussion 406-7. doi: 10.1097/01.SLA.0000029003.66466.B3.'}]}, 'descriptionModule': {'briefSummary': 'Postoperative complications seriously affect the recovery of patients undergoing hepatectomy. Identifying risk factors and develop predictive models of complications for patients with hepatolithiasis undergoing hepatectomy is important for clinical practice.', 'detailedDescription': 'Along with the change of lifestyle and dietary habits, many people are diagnosed with hepatolithiasis that is especially prevalent in Asia. Liver resection remains the favorable curative therapy for hepatolithiasis with a relatively low recurrence rate. Although there have been great improvements in surgical techniques and perioperative management, postoperative complications remain commonplace and seriously threat the recovery of patients undergoing hepatectomy. Therefore, it is important to identify risk factors of complications to improve the overall prognosis of patients. We want to collect the clinical information of patients with hepatolithiasis undergoing hepatectomy, including demographic data , laboratory index, histological features and postoperative complications. Patients are followed up at a interval of 3 month after treatment, and the survival data and recurrence rate are recorded. Then the relationship between clinical data and short-term outcomes after surgery are explored. Then models based on clinical features are developed to predict short-term outcomes after hepatectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with hepatolithiasis who received liver resection for curative intent', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pathologically diagnosed hepatolithiasis\n* without malignancies\n* receiving liver resection\n* Eastern Cooperative Oncology Group performance status (ECOG-PS) 0-2\n* Child-Pugh score of ≤7\n* complete clinical and follow-up information\n* age between 18-80 years old\n\nExclusion Criteria:\n\n* with malignancies\n* receiving other treatments\n* Eastern Cooperative Oncology Group performance status (ECOG-PS) \\>2\n* Child-Pugh score of \\>7\n* incomplete clinical data\n* lost to follow up\n* age \\<18 years old or \\>80 years old'}, 'identificationModule': {'nctId': 'NCT05556434', 'briefTitle': 'Predicting Complications of Hepatolithiasis After Hepatectomy', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Wenzhou Medical University'}, 'officialTitle': 'Machine Learning Algorithms Based on Clinical Data to Predict Postoperative Complications of Patients With Hepatolithiasis Undergoing Hepatectomy', 'orgStudyIdInfo': {'id': 'prognosis of hepatolithiasis'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with postoperative complications', 'description': 'Patients who experienced postoperative complications were divided into the first group. The complications were defined according to the Clavien-Dindo classification system.', 'interventionNames': ['Diagnostic Test: radiological evaluation']}, {'label': 'patients without postoperative complications', 'description': "Patients who didn't experience postoperative complications were divided into the second group.", 'interventionNames': ['Diagnostic Test: radiological evaluation']}], 'interventions': [{'name': 'radiological evaluation', 'type': 'DIAGNOSTIC_TEST', 'description': 'All patients undergoing hepatectomy receive imaging evaluation and laboratory test before and after surgery to define clinical parameters.\n\ndiseases', 'armGroupLabels': ['patients with postoperative complications', 'patients without postoperative complications']}]}, 'contactsLocationsModule': {'locations': [{'zip': '325000', 'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Gang Chen', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'overallOfficials': [{'name': 'Gang Chen, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Wenzhou Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eastern Hepatobiliary Surgery Hospital', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Zhejiang Chinese Medical University', 'class': 'OTHER'}, {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor, Principal Investigator', 'investigatorFullName': 'Gang Chen, MD', 'investigatorAffiliation': 'First Affiliated Hospital of Wenzhou Medical University'}}}}