Pancreatic Head Cancer
Conditions
Brief 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.
Interventions
early identification of SMA to evaluate infiltration
conventional exposure and preparation (Kocher's manoeuvre) before transection of pancreatic parenchyma
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of R1 resections | up to 1.5 years | positive resection margins as described by the pathologists of the University of Heidelberg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exploratory analyses | up to 1.5 years | Exploratory analyses of frequencies of complications and serious adverse events |
Countries
Germany