The ARTERY FIRST Approach for Resection of Pancreatic Head Cancer

Study Overview
=================
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.

Official Title
-----------------
The ARTERY FIRST Approach for Resection of Pancreatic Head Cancer

Conditions
-----------------
Pancreatic Head Cancer

Intervention / Treatment
-----------------
* Procedure: Artery first procedure
* Procedure: No artery first procedure


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artery first group<br>The basic principle of the artery first approach is the early identification of the SMA at its origin at the aorta with the further resection then being guided by its anatomic course. The dissection is carried cephalad along the aorta until the origin of the SMA is reached. The posterior and right aspect of the SMA is then dissected over a few centimeters. On the right side of the SMA a replaced or accessory right hepatic artery, if present, will be identified and preserved. This maneuver should be done, if infiltration of the SMA is suspected as the procedure can be terminated at this point. Once the situation at the SMA is assessed and resectability is confirmed resection will be done. | Procedure: Artery first procedure<br>* early identification of SMA to evaluate infiltration<br>|
| Active Comparator: Conventional Group<br>A wide Kocher manoeuver is performed to fully mobilize the duodenum and the head of the pancreas. The colonic mesentery on the right side is separated from the anterior surface of the duodenum and the head of the pancreas. The size of the tumor and its relation to the superior mesenteric artery, the celiac trunk, the mesentery, the portal vein, and the superior mesenteric vein is assessed. If resectability is given a Kausch-Whipple's resection is performed. | Procedure: No artery first procedure<br>* conventional exposure and preparation (Kocher's manoeuvre) before transection of pancreatic parenchyma<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of R1 resections | positive resection margins as described by the pathologists of the University of Heidelberg | up to 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploratory analyses | Exploratory analyses of frequencies of complications and serious adverse events | up to 1.5 years |