Pancreatoduodenectomy in Pancreatic and Periampullary Tumors (DUOPAN-EPAM)

Fundación para la Investigación del Hospital Clínico de Valencia

Status: Completed

Conditions: Pancreatic and Periampullary Tumors

Treatments: Procedure: Classic approach for pancreatoduodenectomy; Procedure: Superior mesenteric artery approach for pancreatoduodenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02803814

DUOPAN-EPAM

Details and patient eligibility

About

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.

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with pancreatic and periampullary tumors undergo a pancreaticoduodenectomy

Exclusion criteria

• Patients with hepatic or peritoneal metastasis
• Patients with irresectable tumor
• Patients with R2 resection
• Patients Grade IV of the American Society of Anesthesiology Score
• Patients with neoadjuvant treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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154 participants in 2 patient groups

Superior mesenteric artery approach

Experimental group

Description:

Initial approach of the superior mesenteric artery to perform a pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area

Treatment:

Procedure: Superior mesenteric artery approach for pancreatoduodenectomy

Classic approach

Active Comparator group

Description:

Classic approach to perform a pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area

Treatment:

Procedure: Classic approach for pancreatoduodenectomy