Economisation Of Whipple Resection Using An Ultrasonic Dissection Device

Study Overview

Economisation of Whipple Resection Using an Ultrasonic Dissection Device

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.

N/A

Resectable Pancreatic Head Neoplasm
Resectable Periampullary Neoplasm
Chronic Pancreatitis

2908

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2011-01-24	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-01-25
First Submitted that Met QC Criteria 2011-03-21	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-01-29
First Posted (ACTUAL) 2011-03-23	Results First Posted N/A	Last Verified 2019-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Group A Preparation with Harmonic WAVE
: Group B Preparation with conventional modalities

Primary Outcome Measures	Measure Description	Time Frame
Total operation time	Measurement of time regarding incision-closure-time	end of operation

Secondary Outcome Measures	Measure Description	Time Frame
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
postoperative intervention	Postoperative interventions due complications, e.g. pancreatic fistula	end of hospitalization

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Jacob R. Izbicki, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
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.

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