Ignite Creation Date:
2025-12-24 @ 10:18 PM
Ignite Modification Date:
2026-02-01 @ 3:38 PM
Study NCT ID:
NCT04180735
Status:
COMPLETED
Last Update Posted:
2019-11-29
First Post:
2019-08-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intestinal Perforation in Patients Receiving an Orthtopic Liver Transplantation in the Montpellier University Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007416', 'term': 'Intestinal Perforation'}, {'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D007412', 'term': 'Intestinal Fistula'}], 'ancestors': [{'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016031', 'term': 'Liver Transplantation'}], 'ancestors': [{'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D016377', 'term': 'Organ Transplantation'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-25', 'studyFirstSubmitDate': '2019-08-06', 'studyFirstSubmitQcDate': '2019-11-25', 'lastUpdatePostDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the total length of stay', 'timeFrame': '1 month', 'description': 'Evaluate the total length of stay'}, {'measure': 'Evaluate the total length of stay', 'timeFrame': '3 months', 'description': 'Evaluate the total length of stay'}, {'measure': 'Evaluate the total length of stay', 'timeFrame': '6 months.', 'description': 'Evaluate the total length of stay'}], 'secondaryOutcomes': [{'measure': 'Evaluate the occurrence of death', 'timeFrame': '1 month, 3 months, 6 months.', 'description': 'Evaluate the occurrence of death'}, {'measure': 'Evaluate the total number of complications', 'timeFrame': '1 month, 3 months, 6 months.', 'description': 'Evaluate the total number of complications'}, {'measure': 'Evaluate the number of perforations', 'timeFrame': '1 month, 3 months, 6 months.', 'description': 'Evaluate the number of perforations'}, {'measure': 'Evaluate the quality of life', 'timeFrame': '1 month, 3 months, 6 months.', 'description': 'Evaluate the quality of life'}, {'measure': 'Evaluate the occurrence of an acute or chronic rejection', 'timeFrame': '1 month, 3 months, 6 months.', 'description': 'Evaluate the occurrence of an acute or chronic rejection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Risk Factors', 'Survival'], 'conditions': ['Liver Transplantation', 'Intestinal Perforation', 'Digestive System Fistula', 'Intestinal Fistula']}, 'descriptionModule': {'briefSummary': 'Liver transplantation enhances the prognosis of patients with cirrhoses or hepatocellular carcinoma. However some patients develop intestinal perforations for which the prognosis is poor.\n\nThe aim of the study is to evaluate the risk factors of intestinal perforations using a retrospective study scheme.', 'detailedDescription': 'Liver transplantation enhances the prognosis of patients with cirrhoses or hepatocellular carcinoma. However some patients develop intestinal perforations for which the prognosis is poor.\n\nThe aim of the study is to evaluate the risk factors of intestinal perforations using a retrospective study scheme. Previous studies have shown a possible implication of drugs or medical history or intraoperative complications. The investigators aim to describe the other possible risk factors (such as portal vein clampage) and the type of surgery done after the diagnosis and its impact on survival as well.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients having received an orthotopic liver transplantation in the Montpellier University Hospital from 2014 to 2019', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients having received an orthotopic liver transplantation in the Montpellier University Hospital from 2014 to 2019\n* for the group Perforation: patients having during the follow-up a complication such as intestinal perforation. The complete list uses the ICD-10 codes for intestinal perforation, esophageal perforation, duodenal perforation etc.\n\nExclusion Criteria:\n\n* No exclusion criteria'}, 'identificationModule': {'nctId': 'NCT04180735', 'acronym': 'Perfogreffe', 'briefTitle': 'Intestinal Perforation in Patients Receiving an Orthtopic Liver Transplantation in the Montpellier University Hospital', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Intestinal Perforation in Patients Receiving an Orthtopic Liver Transplantation in the Montpellier University Hospital: a Retrospective and Observational Study.', 'orgStudyIdInfo': {'id': 'RECHMPL19_0362'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Perforation', 'description': 'Perforation', 'interventionNames': ['Procedure: Liver transplantation']}, {'label': 'No perforation', 'description': 'No perforation', 'interventionNames': ['Procedure: Liver transplantation']}], 'interventions': [{'name': 'Liver transplantation', 'type': 'PROCEDURE', 'description': 'Liver transplantation', 'armGroupLabels': ['No perforation', 'Perforation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uh Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Fabrizio PANARO, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UH MONTPELLIER'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'collaborators': [{'name': 'Université Montpellier', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}