The ARTERY FIRST Approach for Resection of Pancreatic Head Cancer (Artery first)

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)

Study Overview

• Status: Unknown
• Conditions: Pancreatic Head Cancer
• Intervention / Treatment: Procedure: Artery first procedure; Procedure: No artery first procedure

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.

• Study Type: Interventional
• Enrollment (Anticipated): 124
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69120
      • Recruiting
      • Department of General, Visceral and Transplantation Surgery, University of Heidelberg
      • Contact: Rahbari; Email: nuh.rahbari@med.uni-heidelberg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Artery first group; 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; early identification of SMA to evaluate infiltration
Active Comparator: Conventional Group; 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; conventional exposure and preparation (Kocher's manoeuvre) before transection of pancreatic parenchyma

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

Collaborators and Investigators

• Sponsor: Heidelberg University

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Anticipated): July 1, 2011
• Study Completion (Anticipated): July 1, 2011

Study Registration Dates

• First Submitted: April 7, 2011
• First Submitted That Met QC Criteria: April 7, 2011
• First Posted (Estimate): April 11, 2011

Study Record Updates

• Last Update Posted (Estimate): April 19, 2011
• Last Update Submitted That Met QC Criteria: April 18, 2011
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: NNR-7