Pancreatoduodenectomy in Pancreatic and Periampullary Tumors

Pancreatic and Periampullary Tumors Clinical Trial

— DUOPAN-EPAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02803814
• Other study ID #: DUOPAN-EPAM
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: December 19, 2018

Study information

• Verified date: February 2018
• Source: Fundación para la Investigación del Hospital Clínico de Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: December 19, 2018
• Est. primary completion date: December 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Pancreatic and Periampullary Tumors

Intervention

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
• Classic approach for pancreatoduodenectomy
Pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area using the classical approach

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario de Valencia	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Fundación para la Investigación del Hospital Clínico de Valencia	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of free resection margin (R0)	Histological examination of the surgical specimen	1 month