Economisation of Whipple Resection Using an Ultrasonic Dissection Device

January 25, 2019 updated by: Universitätsklinikum Hamburg-Eppendorf

Economisation of Preparation by Using an Ultrasonic Dissection Device in Partial Pancreatoduodenectomy

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

82

Contacts and Locations

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

Study Locations

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

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

resectable tumor

Exclusion Criteria:

palliative resection

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group A
Preparation with Harmonic WAVE
Group B
Preparation with conventional modalities

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative blood loss
Time Frame: end of operation
end of operation
number of transfusions
Time Frame: within the first 24 hours perioperatively
within the first 24 hours perioperatively
hospitalization time
Time Frame: end of hospitalization
end of hospitalization
resulting cost reduction
Time Frame: end of hospitalization
end of hospitalization
pancreatic fistula
Time Frame: within the first 5 days postoperatively
within the first 5 days postoperatively
postoperative intervention
Time Frame: end of hospitalization
Postoperative interventions due complications, e.g. pancreatic fistula
end of hospitalization

Collaborators and Investigators

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

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: Jacob R. Izbicki, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

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

General Publications

Helpful Links

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 Major Dates

Study Start (Actual)

March 1, 2009

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

January 24, 2011

First Submitted That Met QC Criteria

March 21, 2011

First Posted (Estimate)

March 23, 2011

Study Record Updates

Last Update Posted (Actual)

January 29, 2019

Last Update Submitted That Met QC Criteria

January 25, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2908

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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