Pancreatic and Periampullary Tumors Clinical Trial
Official title:
Pancreatoduodenectomy in Pancreatic and Periampullary Tumors: Initial Approach of the Superior Mesenteric Artery Versus Classical Approach: A Prospective, Randomized, Multicenter Study
Background: Recently it has been observed in pancreatic cancer that after apparently complete
surgical resection, histological examination of the surgical specimen according to a standard
protocol reveals tumor infiltration of the surgical margin in more than 50% of patients. To
increase the resection margin and reduce such high infiltration rate, a new surgical approach
based on the initial dissection of the superior mesenteric artery has been advocated.
Aims: To compare the rate of free resection margin (R0) and oncological results of two
possible approaches to perform a pancreaticoduodenectomy in tumors of the head of the
pancreas and peripancreatic area: the classic approach versus the initial approach of the
superior mesenteric artery.
Methodology: Prospective, randomized, multicenter study in which patients with pancreatic and
periampullary tumors undergo a pancreaticoduodenectomy. In a group the classical approach
from the superior mesenteric vein will be performed and in the other group an initially
dissecting the superior mesenteric artery approach will be carried out. 116 patients are
required and the main variables considered are: free margin rates (R0) or infiltrated by
tumor (R1), postoperative morbidity, mortality, local and systemic recurrence, disease-free
interval and survival at 1, 3 and 5 years.
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