Clinical trial NCT01321450: Economisation of Whipple Resection Using an Ultrasonic Dissection Device
Official title: Economisation of Preparation by Using an Ultrasonic Dissection Device in Partial Pancreatoduodenectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Resectable Pancreatic Head Neoplasm
Resectable Periampullary Neoplasm
Chronic Pancreatitis
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2011-03-23
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients planned for partial pancreatoduodenectomy for pancreatic head carcinoma, periampullary carcinoma, chronic pancreatitis and other benign lesions.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

resectable tumor

Exclusion Criteria:

palliative resection

Primary outcomes:
measure: Total operation time
timeFrame: end of operation
Secondary outcomes:
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
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: UH Eppendorf
city: Athens
country: Greece
facility: Agia Olga hospital
city: Verona
country: Italy
facility: UH Verona
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Jacob R. Izbicki, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.