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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Superior mesenteric artery approach | Experimental | Initial approach of the superior mesenteric artery to perform a pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area |
|
| Classic approach | Active Comparator | Classic approach to perform a pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Superior mesenteric artery approach for pancreatoduodenectomy | Procedure | Pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area using the superior mesenteric artery approach |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of free resection margin (R0) | Histological examination of the surgical specimen | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnico Universitario de Valencia | Valencia | 46010 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31498183 | Derived | Sabater L, Cugat E, Serrablo A, Suarez-Artacho G, Diez-Valladares L, Santoyo-Santoyo J, Martin-Perez E, Ausania F, Lopez-Ben S, Jover-Navalon JM, Garces-Albir M, Garcia-Domingo MI, Serradilla M, Perez-Aguirre E, Sanchez-Perez B, Di Martino M, Senra-Del-Rio P, Falgueras-Verdaguer L, Carabias A, Gomez-Mateo MC, Ferrandez A, Dorcaratto D, Munoz-Forner E, Fondevila C, Padillo J. Does the Artery-first Approach Improve the Rate of R0 Resection in Pancreatoduodenectomy?: A Multicenter, Randomized, Controlled Trial. Ann Surg. 2019 Nov;270(5):738-746. doi: 10.1097/SLA.0000000000003535. |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D016577 | Pancreaticoduodenectomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Classic approach for pancreatoduodenectomy | Procedure | Pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area using the classical approach |
|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |