NCT02803814

Pancreatoduodenectomy in Pancreatic and Periampullary Tumors

Pancreatoduodenectomy in Pancreatic and Periampullary Tumors: Initial Approach of the Superior Mesenteric Artery Versus Classical Approach: A Prospective, Randomized, Multicenter Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pancreatic and Periampullary Tumors

Interventions

Type	Name	Description
PROCEDURE	Superior mesenteric artery approach for pancreatoduodenectomy	Pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area using the superior mesenteric artery approach
PROCEDURE	Classic approach for pancreatoduodenectomy	Pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area using the classical approach

Timeline

• Start date: 2016-02-01
• Primary completion: 2018-12-19
• Completion: 2018-12-19
• First posted: 2016-06-17
• Last updated: 2020-07-22

Locations

1 site across 1 country: Spain