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

Primary Purpose

Pancreatic Head Cancer

Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Artery first procedure
No artery first procedure
Sponsored by
Heidelberg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Head Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of General, Visceral and Transplantation Surgery, University of HeidelbergRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Artery first group

Conventional Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Rate of R1 resections
positive resection margins as described by the pathologists of the University of Heidelberg

Secondary Outcome Measures

Exploratory analyses
Exploratory analyses of frequencies of complications and serious adverse events

Full Information

First Posted
April 7, 2011
Last Updated
April 18, 2011
Sponsor
Heidelberg University
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1. Study Identification

Unique Protocol Identification Number
NCT01332773
Brief Title
The ARTERY FIRST Approach for Resection of Pancreatic Head Cancer
Acronym
Artery first
Official Title
The ARTERY FIRST Approach for Resection of Pancreatic Head Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
July 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Heidelberg University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Head Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Artery first group
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional Group
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Artery first procedure
Intervention Description
early identification of SMA to evaluate infiltration
Intervention Type
Procedure
Intervention Name(s)
No artery first procedure
Intervention Description
conventional exposure and preparation (Kocher's manoeuvre) before transection of pancreatic parenchyma
Primary Outcome Measure Information:
Title
Rate of R1 resections
Description
positive resection margins as described by the pathologists of the University of Heidelberg
Time Frame
up to 1.5 years
Secondary Outcome Measure Information:
Title
Exploratory analyses
Description
Exploratory analyses of frequencies of complications and serious adverse events
Time Frame
up to 1.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nuh N. Rahbari, MD
Phone
+496221
Ext
39448
Email
nuh.rahbari@med.uni-heidelberg.de
First Name & Middle Initial & Last Name or Official Title & Degree
Heike Elbers
Phone
+496221
Ext
36976
Email
heike.elbers@med.uni-heidelberg.de
Facility Information:
Facility Name
Department of General, Visceral and Transplantation Surgery, University of Heidelberg
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rahbari
Email
nuh.rahbari@med.uni-heidelberg.de

12. IPD Sharing Statement

Learn more about this trial

The ARTERY FIRST Approach for Resection of Pancreatic Head Cancer

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