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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Publications:
Additional 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
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
Digestive System Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Pancreatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014