Economisation of Whipple Resection Using an Ultrasonic Dissection Device

NCT ID: NCT01321450

Last Updated: 2019-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Resectable Pancreatic Head Neoplasm Resectable Periampullary Neoplasm Chronic Pancreatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

Preparation with Harmonic WAVE

No interventions assigned to this group

Group B

Preparation with conventional modalities

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

resectable tumor

Exclusion Criteria

palliative resection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacob R. Izbicki, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

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UH Eppendorf

Hamburg, , Germany

Site Status

Agia Olga hospital

Athens, , Greece

Site Status

UH Verona

Verona, , Italy

Site Status

Countries

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Germany Greece Italy

References

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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.

Reference Type BACKGROUND
PMID: 17674959 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17945280 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17599502 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23095609 (View on PubMed)

Related Links

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http://www.uke.de/kliniken/allgemeinchirurgie/

UH Hamburg-Eppendorf - General, Visceral and Thoracic Surgery Department and Clinic

Other Identifiers

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2908

Identifier Type: -

Identifier Source: org_study_id

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