Pancreatoduodenectomy in Pancreatic and Periampullary Tumors

Study Overview
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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.

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

Conditions
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Pancreatic and Periampullary Tumors

Intervention / Treatment
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* Procedure: Superior mesenteric artery approach for pancreatoduodenectomy
* Procedure: Classic approach for pancreatoduodenectomy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatoduodenectomy, Pancreatic tumors, Periampullary tumors