The ARTERY FIRST Approach for Resection of Pancreatic Head Cancer

Pancreatic Head Cancer Clinical Trial

— Artery first  

Official title:

The ARTERY FIRST Approach for Resection of Pancreatic Head Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01332773
• Other study ID #: NNR-7
• Status: Recruiting
• Phase: Phase 3
• First received: April 7, 2011
• Last updated: April 18, 2011
• Start date: March 2010
• Est. completion date: July 2011

Study information

• Verified date: December 2009
• Source: Heidelberg University
• Contact: Nuh N. Rahbari, MD
• Phone: +496221
• Email: nuh.rahbari[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Health authority: Germany: General, Visceral and Transplantation Surgery, University hospidal Heidelberg
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Head Cancer

Intervention

Procedure:
• Artery first procedure
early identification of SMA to evaluate infiltration
• No artery first procedure
conventional exposure and preparation (Kocher's manoeuvre) before transection of pancreatic parenchyma

Locations

Country	Name	City	State
Germany	Department of General, Visceral and Transplantation Surgery, University of Heidelberg	Heidelberg	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of R1 resections	positive resection margins as described by the pathologists of the University of Heidelberg	up to 1.5 years	No
Secondary	Exploratory analyses	Exploratory analyses of frequencies of complications and serious adverse events	up to 1.5 years	Yes