The ARTERY FIRST Approach for Resection of Pancreatic Head Cancer (Artery first)
|ClinicalTrials.gov Identifier: NCT01332773|
Recruitment Status : Unknown
Verified December 2009 by Heidelberg University.
Recruitment status was: Recruiting
First Posted : April 11, 2011
Last Update Posted : April 19, 2011
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Head Cancer||Procedure: Artery first procedure Procedure: No artery first procedure||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The ARTERY FIRST Approach for Resection of Pancreatic Head Cancer|
|Study Start Date :||March 2010|
|Estimated Primary Completion Date :||July 2011|
|Estimated Study Completion Date :||July 2011|
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.
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 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.
Procedure: No artery first procedure
conventional exposure and preparation (Kocher's manoeuvre) before transection of pancreatic parenchyma
- Rate of R1 resections [ Time Frame: up to 1.5 years ]positive resection margins as described by the pathologists of the University of Heidelberg
- Exploratory analyses [ Time Frame: up to 1.5 years ]Exploratory analyses of frequencies of complications and serious adverse events
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01332773
|Contact: Nuh N. Rahbari, MD||+496221 ext firstname.lastname@example.org|
|Contact: Heike Elbers||+496221 ext email@example.com|
|Department of General, Visceral and Transplantation Surgery, University of Heidelberg||Recruiting|
|Heidelberg, Baden-Württemberg, Germany, 69120|
|Contact: Rahbari firstname.lastname@example.org|