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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02803814
Acronym
DUOPAN-EPAM
Enrollment
154
Registered
2016-06-17
Start date
2016-02-29
Completion date
2018-12-19
Last updated
2020-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic and Periampullary Tumors

Keywords

Pancreatoduodenectomy, Pancreatic tumors, Periampullary tumors

Brief 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.

Interventions

PROCEDURESuperior mesenteric artery approach for pancreatoduodenectomy

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

PROCEDUREClassic approach for pancreatoduodenectomy

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

Sponsors

Instituto de Salud Carlos III
CollaboratorOTHER_GOV
Fundación para la Investigación del Hospital Clínico de Valencia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of free resection margin (R0)1 monthHistological examination of the surgical specimen

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026