Pancreatoduodenectomy in Pancreatic and Periampullary Tumors (DUOPAN-EPAM)

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic and Periampullary Tumors
• Intervention / Treatment: Procedure: Superior mesenteric artery approach for pancreatoduodenectomy; Procedure: Classic approach for pancreatoduodenectomy

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Superior mesenteric artery approach; Initial approach of the superior mesenteric artery to perform a pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area	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
Active Comparator: Classic approach; Classic approach to perform a pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area	Procedure: Classic approach for pancreatoduodenectomy; Pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area using the classical approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of free resection margin (R0)	Histological examination of the surgical specimen	1 month

Collaborators and Investigators

• Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
• Collaborators: Instituto de Salud Carlos III

Publications and helpful links

General Publications

• Sabater L, Cugat E, Serrablo A, Suarez-Artacho G, Diez-Valladares L, Santoyo-Santoyo J, Martin-Perez E, Ausania F, Lopez-Ben S, Jover-Navalon JM, Garces-Albir M, Garcia-Domingo MI, Serradilla M, Perez-Aguirre E, Sanchez-Perez B, Di Martino M, Senra-Del-Rio P, Falgueras-Verdaguer L, Carabias A, Gomez-Mateo MC, Ferrandez A, Dorcaratto D, Munoz-Forner E, Fondevila C, Padillo J. Does the Artery-first Approach Improve the Rate of R0 Resection in Pancreatoduodenectomy?: A Multicenter, Randomized, Controlled Trial. Ann Surg. 2019 Nov;270(5):738-746. doi: 10.1097/SLA.0000000000003535.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): December 19, 2018
• Study Completion (Actual): December 19, 2018

Study Registration Dates

• First Submitted: May 23, 2016
• First Submitted That Met QC Criteria: June 14, 2016
• First Posted (Estimate): June 17, 2016

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Pancreatoduodenectomy; Pancreatic tumors; Periampullary tumors
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: DUOPAN-EPAM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO