Pancreatoduodenectomy in Pancreatic and Periampullary Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-12-19

Brief Summary

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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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Detailed Description

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Conditions

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Pancreatic and Periampullary Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Superior mesenteric artery approach for pancreatoduodenectomy

Intervention Type PROCEDURE

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

Classic approach

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

Group Type ACTIVE_COMPARATOR

Classic approach for pancreatoduodenectomy

Intervention Type PROCEDURE

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

Interventions

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Superior mesenteric artery approach for pancreatoduodenectomy

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

Intervention Type PROCEDURE

Classic approach for pancreatoduodenectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No