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 Heidelberg University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT01332773
First received: April 7, 2011
Last updated: April 18, 2011
Last verified: December 2009

April 7, 2011
April 18, 2011
March 2010
July 2011   (final data collection date for primary outcome measure)
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
Rate of R1 resections [ Time Frame: 2010-2011 ] [ Designated as safety issue: No ]
positive resection margins as described by the pathologists of the University of Heidelberg
Complete list of historical versions of study NCT01332773 on ClinicalTrials.gov Archive Site
Exploratory analyses [ Time Frame: up to 1.5 years ] [ Designated as safety issue: Yes ]
Exploratory analyses of frequencies of complications and serious adverse events
Exploratory analyses [ Time Frame: 2010-2011 ] [ Designated as safety issue: Yes ]
Exploratory analyses of frequencies of complications and serious adverse events
Not Provided
Not Provided
 
The ARTERY FIRST Approach for Resection of Pancreatic Head Cancer
The ARTERY FIRST Approach for Resection of Pancreatic Head Cancer

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)

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Head Cancer
  • Procedure: Artery first procedure
    early identification of SMA to evaluate infiltration
  • Procedure: No artery first procedure
    conventional exposure and preparation (Kocher's manoeuvre) before transection of pancreatic parenchyma
  • 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.

    Intervention: Procedure: Artery first procedure
  • 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.
    Intervention: Procedure: No artery first procedure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
124
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
Germany
 
NCT01332773
NNR-7
No
Jürgen Weitz, MD, MSc, Department of General, Visceral and Transplantation Surgery, University of Heidelberg
Heidelberg University
Not Provided
Not Provided
Heidelberg University
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP