The ARTERY FIRST Approach for Resection of Pancreatic Head Cancer
18 Years
N/A
Both
Pancreatic Head Cancer
Trial Information
The ARTERY FIRST Approach for Resection of Pancreatic Head Cancer
This is a prospective non-randomized trial with two study groups. The trial is designed to
show if the ARTERY FIRST approach reduces the rate of R1 resections in patients undergoing
surgery for cancer of the pancreatic head.
After the diagnosis of cancer of the pancreatic head by clinical, laboratory and imaging
evaluation patients who are scheduled for resection will be screened for inclusion into the
trial. Informed consent is obtained at least on the day before surgery and patients meeting
the eligibility criteria will be enrolled into the study.
Inclusion Criteria:
- Pancreatic head cancer (diagnosis by clinical, laboratory and radiological
evaluation)
- Patients scheduled for curative resection
- No evidence of distant metastases
- Age equal or greater than 18 years
- Informed consent
Exclusion Criteria:
- Expected lack of compliance
- Impaired mental state or language problems
- patient having had neoadjuvant radiochemotherapy
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Rate of R1 resections
Outcome Description:
positive resection margins as described by the pathologists of the University of Heidelberg
Outcome Time Frame:
up to 1.5 years
Safety Issue:
No
Authority:
Germany: General, Visceral and Transplantation Surgery, University hospidal Heidelberg
Study ID:
NNR-7
NCT ID:
NCT01332773
Start Date:
March 2010
Completion Date:
July 2011
Related Keywords:
- Pancreatic Head Cancer
- Head and Neck Neoplasms
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