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Economisation of Whipple Resection Using an Ultrasonic Dissection Device

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ClinicalTrials.gov Identifier: NCT01321450
Recruitment Status : Completed
First Posted : March 23, 2011
Last Update Posted : November 8, 2011
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief 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.

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

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Economisation of Preparation by Using an Ultrasonic Dissection Device in Partial Pancreatoduodenectomy
Study Start Date : March 2009
Primary Completion Date : July 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Total operation time [ Time Frame: end of operation ]
    Measurement of time regarding incision-closure-time

Secondary Outcome Measures :
  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 [ Time Frame: end of hospitalization ]
    Postoperative interventions due complications, e.g. pancreatic fistula

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:

palliative resection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321450

UH Eppendorf
Hamburg, Germany, 22529
Agia Olga hospital
Athens, Greece
UH Verona
Verona, Italy, 37134
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Principal Investigator: Jacob R. Izbicki, Prof. Dr. Universitätsklinikum Hamburg-Eppendorf

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01321450     History of Changes
Other Study ID Numbers: 2908
First Posted: March 23, 2011    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases