NCT01321450|Completed
Economisation of Whipple Resection Using an Ultrasonic Dissection Device
Economisation of Preparation by Using an Ultrasonic Dissection Device in Partial Pancreatoduodenectomy
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Economisation of Preparation by Using an Ultrasonic Dissection Device in Partial Pancreatoduodenectomy
Sponsor study identifier
observational
82
3 countries
3
Study Start
March 2009
Actual (reported)Primary Completion
July 2011
Actual (reported)Study Completion
October 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2011
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2009
Actual (reported)January 24, 2011
Actual (reported)March 23, 2011
Actual (reported)July 2011
Actual (reported)October 2011
Actual (reported)Total operation time
Measurement of time regarding incision-closure-time
end of operation
intraoperative blood loss
end of operation
number of transfusions
within the first 24 hours perioperatively
hospitalization time
end of hospitalization
resulting cost reduction
end of hospitalization
pancreatic fistula
within the first 5 days postoperatively
Preparation with Harmonic WAVE
Preparation with conventional modalities
Patients planned for partial pancreatoduodenectomy for pancreatic head carcinoma, periampullary carcinoma, chronic pancreatitis and other benign lesions.
UH Eppendorf
Hamburg, 22529, Germany
Agia Olga hospital
Athens, Greece
UH Verona
Verona, 37134, Italy
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.
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.
Jacob R. Izbicki, Prof. Dr.
Universitätsklinikum Hamburg-Eppendorf
82 participants (actual enrollment reported by the registry).
First Submitted
January 24, 2011
First Posted
March 23, 2011
Study Start
March 2009
Actual (reported)Prospective Study of Efficacy of Intra-muscular Vitamin D3 in Tropical Calcific Pancreatitis
Contact the study team to confirm eligibility.
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.
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.
Primary Completion
July 2011
Actual (reported)Study Completion
October 2011
Actual (reported)Last Updated
January 29, 2019
Record last verified: 2019-01
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Source: ClinicalTrials.gov.
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