Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-25 @ 6:10 PM
Study NCT ID:
NCT02588066
Status:
COMPLETED
Last Update Posted:
2021-02-05
First Post:
2015-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pancreatoduodenectomy With or Without Ligamentum Teres Wrap Around Gastroduodenal Artery Stump for Prevention of Pancreatic Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-04', 'studyFirstSubmitDate': '2015-10-26', 'studyFirstSubmitQcDate': '2015-10-26', 'lastUpdatePostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of arrosion bleeding', 'timeFrame': '>24 hours after partial pancreatoduodenectomy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pancreatoduodenectomy']}, 'referencesModule': {'references': [{'pmid': '34746958', 'type': 'DERIVED', 'citation': 'Welsch T, Mussle B, Korn S, Sturm D, Bork U, Distler M, Grahlert X, Klimova A, Trebesius N, Kleespies A, Kees S, Beckert S, Reim D, Friess H, Elwerr M, Kleeff J, Popescu O, Schmitz-Winnenthal H, Janot-Matuschek M, Uhl W, Weber GF, Brunner M, Golcher H, Grutzmann R, Weitz J. Pancreatoduodenectomy with or without prophylactic falciform ligament wrap around the hepatic artery for prevention of postpancreatectomy haemorrhage: randomized clinical trial (PANDA trial). Br J Surg. 2021 Dec 17;109(1):37-45. doi: 10.1093/bjs/znab363.'}, {'pmid': '29650056', 'type': 'DERIVED', 'citation': 'Mussle B, Zuhlke L, Wierick A, Sturm D, Grahlert X, Distler M, Rahbari NN, Weitz J, Welsch T. Pancreatoduodenectomy with or without prophylactic falciform ligament wrap around the gastroduodenal artery stump for prevention of pancreatectomy hemorrhage. Trials. 2018 Apr 12;19(1):222. doi: 10.1186/s13063-018-2580-0.'}]}, 'descriptionModule': {'briefSummary': 'To investigate, whether a prophylactic wrapping of the gastroduodenal artery stump with the ligamentum teres or falciform hepatic (embryological structures, covered with peritoneum that do not have relevant meaning for adults) can reduce the incidence of arrosion bleeding during surgery.\n\nThus a surgical technique is evaluated prospectively.', 'detailedDescription': 'Pancreatoduodenectomy is a standard surgical procedure for resection of tumors of the pancreatic head and neck, and for selected patients with chronic pancreatitis. A postoperative pancreatic fistula (POPF) is a severe and frequent complication that may lead to a potentially letal arrosion hemorrhage from the stump of the gastroduodenal artery (GDA). Aim of the study is to evaluate the prophylactic wrapping of the GDA stump using the falciform hepatic ligament during the index operation. The null hypothesis is that prophylactic wrapping does not decrease the incidence of arrosion hemorrhage from the GDA stump. The study is designed as a randomized, single-blinded, controlled, multicenter trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for elective open pancreatoduodenectomy (pylorus-preserving or classic) with pancreatojejunostomy for tumors, or cystic lesions of the pancreatic head, tumors of the distal bile duct, duodenum or for chronic pancreatitis\n* american society of anesthesiologists classification I-III\n* age ≥18 years\n* given informed consent\n\nExclusion Criteria:\n\n* status post previous abdominal surgery with resection of the falciform ligament (e.g. hemihepatectomy)\n* No reconstruction using a pancreatojejunostomy (e.g. pancreatogastrostomy)\n* simultaneous visceral arterial resection'}, 'identificationModule': {'nctId': 'NCT02588066', 'briefTitle': 'Pancreatoduodenectomy With or Without Ligamentum Teres Wrap Around Gastroduodenal Artery Stump for Prevention of Pancreatic Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'Pancreatoduodenectomy With or Without Prophylactic Ligamentum Teres Hepatic Wrap Around the Gastroduodenal Artery Stump for Prevention of Pancreatic Hemorrhage - Panda - Multicentric Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'TW-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Index test', 'description': 'Ligamentum teres/falciform-plasty around the gastroduodenal artery stump during pancreatoduodenectomy', 'interventionNames': ['Procedure: Ligamentum teres/falciform-plasty']}, {'type': 'NO_INTERVENTION', 'label': 'Reference test', 'description': 'No Ligamentum teres/falciform-plasty around the gastroduodenal artery stump during pancreatoduodenectomy'}], 'interventions': [{'name': 'Ligamentum teres/falciform-plasty', 'type': 'PROCEDURE', 'description': 'Ligamentum teres/falciform-plasty around the gastroduodenal artery stump during pancreatoduodenectomy', 'armGroupLabels': ['Index test']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dresden', 'country': 'Germany', 'facility': 'Department of Surgery, University Hospital Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}], 'overallOfficials': [{'name': 'Thilo Welsch', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}