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OpenTrials
Completed

NCT Number: NCT02803814

Pancreatoduodenectomy in Pancreatic and Periampullary Tumors

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Superior mesenteric artery approach for pancreatoduodenectomy

Procedure

Pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area using the superior mesenteric artery approach

Classic approach for pancreatoduodenectomy

Procedure

Pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area using the classical approach

Primary outcomes

  1. Rate of free resection margin (R0)

    Time frame: 1 month

    Histological examination of the surgical specimen

Sponsors and collaborators

Lead sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Acronym: DUOPAN-EPAM

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 17, 2016
Registry last updated
Jul 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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