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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01332773
Recruitment Status : Unknown
Verified December 2009 by Heidelberg University.
Recruitment status was:  Recruiting
First Posted : April 11, 2011
Last Update Posted : April 19, 2011
Information provided by:
Heidelberg University

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)

Condition or disease Intervention/treatment Phase
Pancreatic Head Cancer Procedure: Artery first procedure Procedure: No artery first procedure Phase 3

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  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The ARTERY FIRST Approach for Resection of Pancreatic Head Cancer
Study Start Date : March 2010
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : July 2011

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

Primary Outcome Measures :
  1. Rate of R1 resections [ Time Frame: up to 1.5 years ]
    positive resection margins as described by the pathologists of the University of Heidelberg

Secondary Outcome Measures :
  1. Exploratory analyses [ Time Frame: up to 1.5 years ]
    Exploratory analyses of frequencies of complications and serious adverse events

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01332773

Contact: Nuh N. Rahbari, MD +496221 ext 39448
Contact: Heike Elbers +496221 ext 36976

Department of General, Visceral and Transplantation Surgery, University of Heidelberg Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Rahbari   
Sponsors and Collaborators
Heidelberg University

Responsible Party: Jürgen Weitz, MD, MSc, Department of General, Visceral and Transplantation Surgery, University of Heidelberg Identifier: NCT01332773     History of Changes
Other Study ID Numbers: NNR-7
First Posted: April 11, 2011    Key Record Dates
Last Update Posted: April 19, 2011
Last Verified: December 2009

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site