The ARTERY FIRST Approach for Resection of Pancreatic Head Cancer
Conditions
Pancreatic Head Cancer
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Artery first procedure Type: Procedure
Name: No artery first procedure Type: Procedure
Overall Status
Recruiting
Summary
To show whether the artery first approach leads to equal or less rate of positive resection margins in pancreatic head cancer than the standard technique (ppWhipple only with standard Kocher's manoeuvre)
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Department of General, Visceral and Transplantation Surgery, University of Heidelberg
Heidelberg, Baden-Württemberg, Germany
Status: Recruiting
Contact: Rahbari - nuh.rahbari@med.uni-heidelberg.de
Start Date
March 2010
Completion Date
July 2011
Sponsors
Heidelberg University
Source
Heidelberg University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page