Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 11:30 PM
Study NCT ID:
NCT06205693
Status:
COMPLETED
Last Update Posted:
2025-06-08
First Post:
2023-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intraoperative Biodegradable Stent Placement to Reduce Complications After Pancreatoduodenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010185', 'term': 'Pancreatic Fistula'}, {'id': 'D005402', 'term': 'Fistula'}], 'ancestors': [{'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The investigators will mask the allocation for the outcome assessors and trial statistician who will conduct the analyses, and the author group while writing the abstract for the trial report with the two intervention groups coded as 0 and 1. Due to the nature of the intervention and control, the trial will not be blinded for the surgeons performing the interventions'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective, randomized, blinded clinical superiority trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2023-12-14', 'studyFirstSubmitQcDate': '2024-01-12', 'lastUpdatePostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'POPF', 'timeFrame': '30 days', 'description': 'Number of participants with a Postoperative pancreatic fistula'}, {'measure': 'Number of participants with a Biliary fistula', 'timeFrame': '30 days', 'description': 'Postoperative biliary fistula'}], 'secondaryOutcomes': [{'measure': 'Complications to stent placement', 'timeFrame': '30 days', 'description': 'Incidence of complications to placement of the biodegradable stent, including displacement.'}, {'measure': 'Postoperative complications', 'timeFrame': '30 days postoperative', 'description': 'Overall incidence of complications following PD classified according to Clavien-Dindo'}, {'measure': 'Mortality', 'timeFrame': '30 days and 90 days', 'description': 'Participant Mortality at 30 and 90 days'}, {'measure': 'LOS', 'timeFrame': 'Length in days, from surgery until discharge ( up to 200 days from surgery)', 'description': 'Participant Length of hospital stay (LOS).'}, {'measure': 'Quality of Life according to VR12 Quality of Life Score', 'timeFrame': '30 days post surgery', 'description': 'Patient reported quality of life according to VR12 Quality of Life Score (activity level, pain episodes, pain levels, patient mood)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fistula', 'postoperative pancreatic fistula', 'pancreatoduodenectomy'], 'conditions': ['Fistula Pancreatic']}, 'descriptionModule': {'briefSummary': 'The aim of this prospective, randomized, blinded clinical superiority trial is to establish intraoperative placement of biodegradable stents in the pancreatojejunostomy as a safe, effective, and feasible preventive measure against pancreatic fistula following pancreatoduodenectomy.\n\nThe investigators hypothesize that intraoperative placement of biodegradable stents in the pancreatojejunostomy is safe and can reduce the risk of pancreatic leakage following pancreatoduodenectomy in patients who have not undergone PBD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients undergoing a pancreatoduodenectomy\n2. Patients aged 18 or above\n3. Patients who have given an informed consent\n\nExclusion Criteria:\n\n1. Patients who do not or cannot give an informed consent.\n2. Patients with at a high risk or with previous history of multiple thrombo-embolic diseases or bleeding disorders.\n3. Patients undergoing active immunosuppressive therapy.'}, 'identificationModule': {'nctId': 'NCT06205693', 'briefTitle': 'Intraoperative Biodegradable Stent Placement to Reduce Complications After Pancreatoduodenectomy', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Intraoperative Biodegradable Stent Placement to Reduce Complications After Pancreatoduodenectomy - Protocol and Statistical Analysis Plan for Randomized, Clinical Trial', 'orgStudyIdInfo': {'id': 'Stent-trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Stent', 'description': 'Placement of biodegradable stent intraoperatively.', 'interventionNames': ['Procedure: Fast Degradable, Biodegradable ARCHEMEDES stent']}, {'type': 'NO_INTERVENTION', 'label': 'No stent', 'description': 'Control group. No placement of stent.'}], 'interventions': [{'name': 'Fast Degradable, Biodegradable ARCHEMEDES stent', 'type': 'PROCEDURE', 'description': 'Fast Degradable, Biodegradable ARCHEMEDES stent. Placed in the pancreaticojejunostomy.', 'armGroupLabels': ['Stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'Capitol', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Generel Surgeon', 'investigatorFullName': 'Waqas Farooqui', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}