The ARTERY FIRST Approach for Resection of Pancreatic Head Cancer

NCT ID: NCT01332773

Last Updated: 2011-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-07-31

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.

Conditions

Pancreatic Head Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Artery first procedure

Intervention Type: PROCEDURE

early identification of SMA to evaluate infiltration

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.

Group Type: ACTIVE_COMPARATOR

No artery first procedure

Intervention Type: PROCEDURE

conventional exposure and preparation (Kocher's manoeuvre) before transection of pancreatic parenchyma

Interventions

Artery first procedure

early identification of SMA to evaluate infiltration

Intervention Type: PROCEDURE

No artery first procedure

conventional exposure and preparation (Kocher's manoeuvre) before transection of pancreatic parenchyma

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

Department of General, Visceral and Transplantation Surgery, University of Heidelberg

Locations

Department of General, Visceral and Transplantation Surgery, University of Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Nuh N. Rahbari, MD

Role: CONTACT

nuh.rahbari@med.uni-heidelberg.de

+496221 ext. 39448

Heike Elbers

Role: CONTACT

heike.elbers@med.uni-heidelberg.de

+496221 ext. 36976

Facility Contacts

Rahbari

Role: primary

nuh.rahbari@med.uni-heidelberg.de

Other Identifiers

NNR-7

Identifier Type: -

Identifier Source: org_study_id