Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic and Periampullary Tumors | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Classic approach for pancreatoduodenectomy | Procedure | — | UNRESOLVED |
| Superior mesenteric artery approach for pancreatoduodenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Superior mesenteric artery approach
- description
- Initial approach of the superior mesenteric artery to perform a pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area
- interventionNames
- Procedure: Superior mesenteric artery approach for pancreatoduodenectomy
- type
- ACTIVE_COMPARATOR
- label
- Classic approach
- description
- Classic approach to perform a pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area
- interventionNames
- Procedure: Classic approach for pancreatoduodenectomy
Primary outcomes (1)
- measure
- Rate of free resection margin (R0)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSabater 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. PMID 31498183