The ARTERY FIRST Approach For Resection Of Pancreatic Head Cancer

Study Overview

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.

Pancreatic Head Cancer

PROCEDURE: Artery first procedure
PROCEDURE: No artery first procedure

NNR-7

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2011-04-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2011-04-18
First Submitted that Met QC Criteria 2011-04-07	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2011-04-19
First Posted (ESTIMATED) 2011-04-11	Results First Posted N/A	Last Verified 2009-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/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	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 re	PROCEDURE: No artery first procedure conventional exposure and preparation (Kocher's manoeuvre) before transection of pancreatic parenchyma

Participant Group/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

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 re

PROCEDURE: No artery first procedure

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

Primary Outcome Measures	Measure Description	Time Frame
Rate of R1 resections	positive resection margins as described by the pathologists of the University of Heidelberg	up to 1.5 years

Secondary Outcome Measures	Measure Description	Time Frame
Exploratory analyses	Exploratory analyses of frequencies of complications and serious adverse events	up to 1.5 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Nuh N. Rahbari, MD

Phone Number: +496221

Email: [email protected]

Study Contact Backup

Name: Heike Elbers

Phone Number: +496221

Email: [email protected]

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Expected lack of compliance
Impaired mental state or language problems
patient having had neoadjuvant radiochemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record