Pancreatoduodenectomy in Pancreatic and Periampullary Tumors

Not Applicable

Completed

• Conditions: Pancreatic and Periampullary Tumors
• Interventions: Procedure: Classic approach for pancreatoduodenectomy; Procedure: Superior mesenteric artery approach for pancreatoduodenectomy

• Registration Number: NCT02803814
• Lead Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-05-23
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-17
• Status Verified: 2018-02
• Primary Completion: 2018-12-19
• Study Completion: 2018-12-19
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Classic approach	Classic approach for pancreatoduodenectomy	Classic approach to perform a pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area
Superior mesenteric artery approach	Superior mesenteric artery approach for pancreatoduodenectomy	Initial approach of the superior mesenteric artery to perform a pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area

Primary Outcome Measures

Name	Time	Method
Rate of free resection margin (R0)	1 month	Histological examination of the surgical specimen

Trial Locations

Locations (1)

Hospital Clínico Universitario de Valencia; 🇪🇸 Valencia, Spain