Economisation of Whipple Resection Using an Ultrasonic Dissection Device

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Universitätsklinikum Hamburg-Eppendorf

ClinicalTrials.gov Identifier:

NCT01321450

First received: January 24, 2011

Last updated: November 5, 2011

Last verified: November 2011

History of Changes

Purpose

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.

Condition
Patients Planned for Partial Pancreatoduodenectomy for Pancreatic Head Carcinoma, Periampullary Carcinoma, Chronic Pancreatitis and Other Benign Lesions.

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Economisation of Preparation by Using an Ultrasonic Dissection Device in Partial Pancreatoduodenectomy

Resource links provided by NLM:

Genetics Home Reference related topics: hereditary pancreatitis

MedlinePlus related topics: Pancreatitis

U.S. FDA Resources

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:

Total operation time [ Time Frame: end of operation ] [ Designated as safety issue: No ]
Measurement of time regarding incision-closure-time

Secondary Outcome Measures:

intraoperative blood loss [ Time Frame: end of operation ] [ Designated as safety issue: No ]
number of transfusions [ Time Frame: within the first 24 hours perioperatively ] [ Designated as safety issue: No ]
hospitalization time [ Time Frame: end of hospitalization ] [ Designated as safety issue: No ]
resulting cost reduction [ Time Frame: end of hospitalization ] [ Designated as safety issue: No ]
pancreatic fistula [ Time Frame: within the first 5 days postoperatively ] [ Designated as safety issue: No ]
postoperative intervention [ Time Frame: end of hospitalization ] [ Designated as safety issue: No ]
Postoperative interventions due complications, e.g. pancreatic fistula

Estimated Enrollment:	150
Study Start Date:	March 2009
Study Completion Date:	October 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
Group A Preparation with Harmonic WAVE
Group B Preparation with conventional modalities

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients planned for partial pancreatoduodenectomy for pancreatic head carcinoma, periampullary carcinoma, chronic pancreatitis and other benign lesions.

Criteria

Inclusion Criteria:

resectable tumor

Exclusion Criteria:

palliative resection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01321450

Locations

Germany
UH Eppendorf
Hamburg, Germany, 22529
Greece
Agia Olga hospital
Athens, Greece
Italy
UH Verona
Verona, Italy, 37134

Sponsors and Collaborators

Universitätsklinikum Hamburg-Eppendorf

Investigators

Principal Investigator:

Jacob R. Izbicki, Prof. Dr.

Universitätsklinikum Hamburg-Eppendorf

More Information

Additional Information:

UH Hamburg-Eppendorf - General, Visceral and Thoracic Surgery Department and Clinic This link exits the ClinicalTrials.gov site

Publications:

Ujiki MB, Talamonti MS. Guidelines for the surgical management of pancreatic adenocarcinoma. Semin Oncol. 2007 Aug;34(4):311-20. Review.

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. 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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:	NCT01321450 History of Changes
Other Study ID Numbers:	2908
Study First Received:	January 24, 2011
Last Updated:	November 5, 2011
Health Authority:	Germany: Ethics Commission Germany: German Institute of Medical Documentation and Information

Additional relevant MeSH terms:

Carcinoma
Pancreatitis
Pancreatitis, Chronic
Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type
Neoplasms
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013

To Top