Ignite Creation Date:
2025-12-24 @ 3:26 PM
Ignite Modification Date:
2026-01-05 @ 3:28 PM
Study NCT ID:
NCT06533592
Status:
RECRUITING
Last Update Posted:
2024-10-24
First Post:
2024-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of the Type of Conduit-duct Anastomosis Technique on the Postoperative Course in Patients Undergoing Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003251', 'term': 'Constriction, Pathologic'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 284}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2028-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-21', 'studyFirstSubmitDate': '2024-07-09', 'studyFirstSubmitQcDate': '2024-07-29', 'lastUpdatePostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bile leakage', 'timeFrame': '90 days post transplantation', 'description': 'Defined as bilirubin concentration in the drain fluid at least 3 times the serum bilirubin concentration or as the need for radiologic or operative intervention resulting from biliary collections or bile peritonitis up to 90 days post transplantation'}], 'secondaryOutcomes': [{'measure': 'Critical biliary stricture', 'timeFrame': '90 days post transplantation', 'description': 'Defined as the need for radiologic, endoscopic or operative intervention resulting from increased serum bilirubin concentration'}, {'measure': 'Other surgical complications', 'timeFrame': '90 days post transplantation', 'description': 'Occurence of complication assessed in Clavien-Dindo scale'}, {'measure': 'Long-term biliary complications', 'timeFrame': '2 years post transplantation', 'description': 'Defined as occurence of biliary leak, biliary stricture, peripheral cholangiopathy, recurrent cholangitis between 90 days and 2 years post transplantation'}, {'measure': 'Overall survival', 'timeFrame': '2 years post transplantation'}, {'measure': 'Overall graft survival', 'timeFrame': '2 years post transplantation'}, {'measure': 'Impact of the occurrence of a biliary complication on the quality of life of patients', 'timeFrame': '2 years post transplantation', 'description': 'Evaluated with EORTC QLQ-C30 form'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Transplant; Complications', 'Bile Duct; Stricture, Postoperative', 'Bile Leak', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'The main objective of the trial is to compare the effect of two end-to-end duct-to-duct anastomosis surgical techniques using the continuous suture method versus interrupted method (control group) on reducing the risk of bile leakages in the 90-day follow-up period after liver transplantation and other postoperative complications resulting from them i.e.: the occurrence of a critical stenosis in the duct-to-duct anastomosis within 90 days. In addition, as part of the research experiment, long-term biliary complications will be assessed, i.e. occurring over a period of more than 90 days (a 2-year observation period of patients was assumed).\n\nAs part of the trial 284 patients qualified for the procedure of liver transplantation from a deceased donor will be included, in whom end-to-end anastomosis of the bile ducts will be performed. After entering the study, patients will be randomized to one of the groups. In the group of 142 patients, duct-to-duct anastomosis will be performed using an interrupted suture (control group), and the remaining patients will be performed using the continuous suture technique.\n\nThe analysis will also include surgical complications, complications related to early and late graft function, retransplantation and overall survival.\n\nAdditionally the analyses an analysis of the impact of the occurrence of a biliary complication on the quality of life of patients after liver transplantation will be performed on the basis of the EORTC QLQ-C30 forms.\n\nThe period of observation of the patient after the procedure is planned for 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age over 18\n* elective liver transplantation\n* informed consent to participate in the study\n* recipient bile duct diameter over 3mm\n* donor bile duct diameter over 3mm\n\nExclusion Criteria:\n\n* age below 18\n* pregnancy\n* living donor liver transplantation\n* split-liver or reduced-size liver transplantation\n* liver transplantation other than from brain death donor\n* liver transplantation with hepaticojejunostomy\n* patients undergoing re-transplantation\n* multi-organ transplantation\n* recipient bile duct diameter below 3mm\n* donor bile duct diameter below 3mm'}, 'identificationModule': {'nctId': 'NCT06533592', 'briefTitle': 'The Effect of the Type of Conduit-duct Anastomosis Technique on the Postoperative Course in Patients Undergoing Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'A Prospective Randomized Study to Evaluate the Effect of the Type of Conduit-duct Anastomosis Using the Single/continuous Suture Technique on the Postoperative Course in Patients Undergoing Liver Transplantation from a Deceased Donor.', 'orgStudyIdInfo': {'id': '2023/ABM/01/00017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Continuous suture technique', 'description': 'Biliary duct-to-duct anastomosis performed with continous suture technique', 'interventionNames': ['Procedure: Continous suture technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Interrupted suture', 'description': 'Biliary duct-to-duct anastomosis performed with interrupted suture technique - control group', 'interventionNames': ['Procedure: Interrupted suture technique']}], 'interventions': [{'name': 'Continous suture technique', 'type': 'PROCEDURE', 'description': 'Duct-to-duct anastomosis will be performed using continuous suture technique for study group', 'armGroupLabels': ['Continuous suture technique']}, {'name': 'Interrupted suture technique', 'type': 'PROCEDURE', 'description': 'Duct-to-duct anastomosis will be performed using an interrupted suture for control group,', 'armGroupLabels': ['Interrupted suture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02-097', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Krzysztof Dudek, MD, PhD', 'role': 'CONTACT', 'email': 'krzysztof.dudek@wum.edu.pl', 'phone': '+48 225992542'}, {'name': 'Jan Stypułkowski, MD', 'role': 'CONTACT', 'email': 'jan.stypulkowski@wum.edu.pl', 'phone': '+48 225992459'}], 'facility': 'Department of General, Transplantation and Liver Surgery UCC MUW', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Krzysztof Dudek, MD, PhD', 'role': 'CONTACT', 'email': 'krzysztof.dudek@wum.edu.pl', 'phone': '+48 225992542'}, {'name': 'Jan Stypułkowski, MD', 'role': 'CONTACT', 'email': 'jan.stypulkowski@wum.edu.pl', 'phone': '+48 225992459'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}