Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-28 @ 2:08 PM
Study NCT ID:
NCT01321450
Status:
COMPLETED
Last Update Posted:
2019-01-29
First Post:
2011-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Economisation of Whipple Resection Using an Ultrasonic Dissection Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050500', 'term': 'Pancreatitis, Chronic'}], 'ancestors': [{'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-25', 'studyFirstSubmitDate': '2011-01-24', 'studyFirstSubmitQcDate': '2011-03-21', 'lastUpdatePostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total operation time', 'timeFrame': 'end of operation', 'description': 'Measurement of time regarding incision-closure-time'}], 'secondaryOutcomes': [{'measure': 'intraoperative blood loss', 'timeFrame': 'end of operation'}, {'measure': 'number of transfusions', 'timeFrame': 'within the first 24 hours perioperatively'}, {'measure': 'hospitalization time', 'timeFrame': 'end of hospitalization'}, {'measure': 'resulting cost reduction', 'timeFrame': 'end of hospitalization'}, {'measure': 'pancreatic fistula', 'timeFrame': 'within the first 5 days postoperatively'}, {'measure': 'postoperative intervention', 'timeFrame': 'end of hospitalization', 'description': 'Postoperative interventions due complications, e.g. pancreatic fistula'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Resectable Pancreatic Head Neoplasm', 'Resectable Periampullary Neoplasm', 'Chronic Pancreatitis']}, 'referencesModule': {'references': [{'pmid': '17674959', 'type': 'BACKGROUND', 'citation': 'Ujiki MB, Talamonti MS. Guidelines for the surgical management of pancreatic adenocarcinoma. Semin Oncol. 2007 Aug;34(4):311-20. doi: 10.1053/j.seminoncol.2007.05.004.'}, {'pmid': '17945280', 'type': 'BACKGROUND', 'citation': 'Hruby GW, Marruffo FC, Durak E, Collins SM, Pierorazio P, Humphrey PA, Mansukhani MM, Landman J. Evaluation of surgical energy devices for vessel sealing and peripheral energy spread in a porcine model. J Urol. 2007 Dec;178(6):2689-93. doi: 10.1016/j.juro.2007.07.121. Epub 2007 Oct 22.'}, {'pmid': '17599502', 'type': 'BACKGROUND', 'citation': 'Nicastri DG, Wu M, Yun J, Swanson SJ. Evaluation of efficacy of an ultrasonic scalpel for pulmonary vascular ligation in an animal model. J Thorac Cardiovasc Surg. 2007 Jul;134(1):160-4. doi: 10.1016/j.jtcvs.2007.02.015.'}, {'pmid': '23095609', 'type': 'DERIVED', 'citation': 'Uzunoglu FG, Stehr A, Fink JA, Vettorazzi E, Koenig A, Gawad KA, Vashist YK, Kutup A, Mann O, Gavazzi F, Zerbi A, Bassi C, Dervenis C, Montorsi M, Bockhorn M, Izbicki JR. Ultrasonic dissection versus conventional dissection techniques in pancreatic surgery: a randomized multicentre study. Ann Surg. 2012 Nov;256(5):675-9; discussion 679-80. doi: 10.1097/SLA.0b013e318271cefa.'}], 'seeAlsoLinks': [{'url': 'http://www.uke.de/kliniken/allgemeinchirurgie/', 'label': 'UH Hamburg-Eppendorf - General, Visceral and Thoracic Surgery Department and Clinic'}]}, 'descriptionModule': {'briefSummary': 'Including 150 randomised patient, the studies aim is to determine whether an economisation and/or improvement in terms of operating time, drainage fluid, blood loss, time of hospitalisation can be found using an ultrasonic dissection device versus traditional surgical methods such as stitches an ligations.The study is performed for patients undergoing partial pancreatoduodenectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients planned for partial pancreatoduodenectomy for pancreatic head carcinoma, periampullary carcinoma, chronic pancreatitis and other benign lesions.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nresectable tumor\n\nExclusion Criteria:\n\npalliative resection'}, 'identificationModule': {'nctId': 'NCT01321450', 'briefTitle': 'Economisation of Whipple Resection Using an Ultrasonic Dissection Device', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Economisation of Preparation by Using an Ultrasonic Dissection Device in Partial Pancreatoduodenectomy', 'orgStudyIdInfo': {'id': '2908'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': 'Preparation with Harmonic WAVE'}, {'label': 'Group B', 'description': 'Preparation with conventional modalities'}]}, 'contactsLocationsModule': {'locations': [{'zip': '22529', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'UH Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Agia Olga hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '37134', 'city': 'Verona', 'country': 'Italy', 'facility': 'UH Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}], 'overallOfficials': [{'name': 'Jacob R. Izbicki, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Hamburg-Eppendorf'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}