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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by University of Heidelberg.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01332773
First received: April 7, 2011
Last updated: April 18, 2011
Last verified: December 2009
History of Changes
  Purpose

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 Intervention Phase
Pancreatic Head Cancer
 Procedure: Artery first procedure
Procedure: No artery first procedure
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The ARTERY FIRST Approach for Resection of Pancreatic Head Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:
  • Rate of R1 resections [ Time Frame: up to 1.5 years ] [ Designated as safety issue: No ]
    positive resection margins as described by the pathologists of the University of Heidelberg


Secondary Outcome Measures:
  • Exploratory analyses [ Time Frame: up to 1.5 years ] [ Designated as safety issue: Yes ]
    Exploratory analyses of frequencies of complications and serious adverse events


Estimated Enrollment: 124
Study Start Date: March 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332773

Contacts
Contact: Nuh N. Rahbari, MD +496221 ext 39448 nuh.rahbari@med.uni-heidelberg.de
Contact: Heike Elbers +496221 ext 36976 heike.elbers@med.uni-heidelberg.de

Locations
Germany
Department of General, Visceral and Transplantation Surgery, University of Heidelberg Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Rahbari         nuh.rahbari@med.uni-heidelberg.de    
Sponsors and Collaborators
University of Heidelberg
  More Information

No publications provided

Responsible Party: Jürgen Weitz, MD, MSc, Department of General, Visceral and Transplantation Surgery, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01332773     History of Changes
Other Study ID Numbers: NNR-7
Study First Received: April 7, 2011
Last Updated: April 18, 2011
Health Authority: Germany: General, Visceral and Transplantation Surgery, University hospidal Heidelberg

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

ClinicalTrials.gov processed this record on May 21, 2013