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CompletedNCT01321450Updated Jan 29, 2019

Economisation of Whipple Resection Using an Ultrasonic Dissection Device

An observational study in Resectable Pancreatic Head Neoplasm, Resectable Periampullary Neoplasm and Chronic Pancreatitis, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-29.

Sponsored by Universitätsklinikum Hamburg-Eppendorf · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
82
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Resectable Pancreatic Head Neoplasm
  • Resectable Periampullary Neoplasm
  • Chronic Pancreatitis
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 82 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 403 studies on the registry; 83 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Inclusion criteria

resectable tumor

Exclusion criteria

Exclusion Criteria:

palliative resection

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
82 participants (actual)

Groups and cohorts

  • Group A

    Preparation with Harmonic WAVE

  • Group B

    Preparation with conventional modalities

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What researchers measure

Primary outcomes

  1. Total operation time

    Measurement of time regarding incision-closure-time

    Time frame: end of operation

Secondary outcomes

  1. intraoperative blood loss

    Time frame: end of operation

  2. number of transfusions

    Time frame: within the first 24 hours perioperatively

  3. hospitalization time

    Time frame: end of hospitalization

  4. resulting cost reduction

    Time frame: end of hospitalization

  5. pancreatic fistula

    Time frame: within the first 5 days postoperatively

  6. postoperative intervention

    Postoperative interventions due complications, e.g. pancreatic fistula

    Time frame: end of hospitalization

07

Study locations

3 sites
  • UH Eppendorf
    Hamburg, 22529, Germany
  • Agia Olga hospital
    Athens, Greece
  • UH Verona
    Verona, 37134, Italy
08

References and documents

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. PubMed 17674959 ↗
  • 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. PubMed 17945280 ↗
  • 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. PubMed 17599502 ↗
  • 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. PubMed 23095609 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01321450
Lead sponsor
Universitätsklinikum Hamburg-Eppendorf
Responsible party
Sponsor
First posted
Mar 23, 2011
Start date
Mar 2009
Primary completion
Jul 2011
Completion
Oct 2011
Last update
Jan 29, 2019

Study contacts

Jacob R. Izbicki, Prof. Dr.
principal investigator · Universitätsklinikum Hamburg-Eppendorf

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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