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Does the Artery-first Approach Improve the Rate of R0 Resection in Pancreatoduodenectomy?

A Multicenter, Randomized, Controlled Trial

Sabater, Luis MD, PhD*; Cugat, Esteban MD, PhD; Serrablo, Alejandro MD, PhD; Suarez-Artacho, Gonzalo MD, PhD§; Diez-Valladares, Luis MD, PhD; Santoyo-Santoyo, Julio MD, PhD||; Martín-Pérez, Elena MD, PhD**; Ausania, Fabio MD, PhD††; Lopez-Ben, Santiago MD‡‡; Jover-Navalon, Jose Maria MD, PhD§§; Garcés-Albir, Marina MD, PhD*; Garcia-Domingo, Maria Isabel MD, PhD; Serradilla, Mario MD; Pérez-Aguirre, Elia MD, PhD; Sánchez-Pérez, Belinda MD, PhD||; Di Martino, Marcello MD, PhD**; Senra-del-Rio, Paula MD, PhD††; Falgueras-Verdaguer, Laia MD‡‡; Carabias, Alberto MD, PhD§§; Gómez-Mateo, Mari Carmen MD, PhD¶¶; Ferrandez, Antonio MD, PhD||||; Dorcaratto, Dimitri MD, PhD*; Muñoz-Forner, Elena MD, PhD*; Fondevila, Constantino MD, PhD***; Padillo, Javier MD, PhD§

doi: 10.1097/SLA.0000000000003535
ESA-RANDOMIZED CONTROLLED TRIALS
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Objective: To compare the rates of R0 resection in pancreatoduodenectomy (PD) for pancreatic and periampullary malignant tumors by means of standard (ST-PD) versus artery-first approach (AFA-PD).

Background: Standardized histological examination of PD specimens has shown that most pancreatic resections thought to be R0 resections are R1. “Artery-first approach” is a surgical technique characterized by meticulous dissection of arterial planes and clearing of retropancreatic tissue in an attempt to achieve a higher rate of R0. To date, studies comparing AFA-PD versus ST-PD are retrospective cohort or case-control studies.

Methods: A multicenter, randomized, controlled trial was conducted in 10 University Hospitals (NCT02803814, ClinicalTrials.gov). Eligible patients were those who presented with pancreatic head adenocarcinoma and periampullary tumors (ampulloma, distal cholangiocarcinoma, duodenal adenocarcinoma). Assignment to each group (ST-PD or AFA-PD) was randomized by blocks and stratified by centers. The primary end-point was the rate of tumor-free resection margins (R0); secondary end-points were postoperative complications and mortality.

Results: One hundred seventy-nine patients were assessed for eligibility and 176 randomized. After exclusions, the final analysis included 75 ST-PD and 78 AFA-PD. R0 resection rates were 77.3% (95% CI: 68.4–87.4) with ST-PD and 67.9% (95% CI: 58.3–79.1) with AFA-PD, P=0.194. There were no significant differences in postoperative complication rates, overall 73.3% versus 67.9%, and perioperative mortality 4% versus 6.4%.

Conclusions: Despite theoretical oncological advantages associated with AFA-PD and evidence coming from low-level studies, this multicenter, randomized, controlled trial has found no difference neither in R0 resection rates nor in postoperative complications in patients undergoing ST-PD versus AFA-PD for pancreatic head adenocarcinoma and other periampullary tumors.

*Department of Surgery, Hospital Clínico, University of Valencia, Biomedical Research Institute INCLIVA, Valencia, Spain

Department of Surgery, Hospital Universitario Mutua Terrassa, Terrassa, Hospital Germans Trias i Puyol, Barcelona, Spain

Department of Surgery, Hospital Miguel Servet, Zaragoza, Zaragoza, Spain

§Department of Surgery, Hospital Virgen del Rocío, Sevilla, Spain

Department of Surgery, Hospital Clínico San Carlos, Madrid, Spain

||Department of Surgery, Hospital Regional Universitario Carlos Haya, Málaga, Spain

**Department of Surgery, Hospital Universitario La Princesa, Madrid, Spain

††Department of Surgery, Hospital Universitario Alvaro Cunqueiro, Vigo, Spain

‡‡Department of Surgery, Hospital Universitari de Girona Dr Josep Trueta, Girona, Spain

§§Department of Surgery, Hospital Universitario de Getafe, Madrid, Getafe, Spain

¶¶Department of Pathology, Hospital Universitario Donostia, San Sebastián, Spain

||||Department of Pathology, Hospital Clínico, University of Valencia, Biomedical Research Institute INCLIVA, Valencia, Spain

***Department of Surgery, Hospital Clinic, IDIBAPS, University of Barcelona, Barcelona, Spain.

luis.sabater@uv.es; luis_sabater@hotmail.com.

This work was supported by a grant from Spain's Ministry of Economy and Competitiveness through the Carlos III Health Institute PI15/00076 and by the SCReN-Spanish Clinical Research Network (PT13/0002/0031; PT17/0017/0003; co-financed by European Regional Development Fund “A way to make Europe”).

All the authors included in this paper declare to have received no funding for this work from any of the following organizations: National Institutes of Health (NIH); Wellcome Trust; Howard Hughes Medical Institute (HHMI); and other(s).

All the authors declare also that neither they nor their institutions at any time have received payment or support in kind for any aspect of the submitted work (including grants, data monitoring board, study design, manuscript preparation, statistical analysis, etc.).

L.S. has participated in the development of teaching resources, advisory and educational programs for Abbott, Mylan, Johnson and Johnson, and Medtronic.

E.C., none declared.

A.S., none declared.

G.S.-A., none declared.

L.D.-V., none declared.

J.S.-S., none declared.

E.M.-P. has participated in the development of teaching resources, advisory, and educational programs for Mylan, Ipsen, and Novartis.

F.A. has participated in the development of teaching resources, advisory, and educational programs for Mylan and Baxter.

S.L.-B. received consulting fees from Medtronic, Baxter, and Integra.

J.M.J.-N., none declared.

M.G.-A., none declared.

M.G.-D., none declared.

M.S. has participated in the development of teaching resources, advisory and educational programs for Baxter.

E.P.-A., none declared.

B.S.-P., none declared.

M.D.M. has participated in the development of teaching resources, advisory, and educational programs for Mylan.

P.S.-d.-R., none declared.

L.F.-V., none declared

A.C., none declared.

M.C.G.-M., none declared.

A.F., none declared.

D.D., none declared.

E.M.-F., none declared.

C.F., none declared.

J.P., none declared.

The authors report no conflicts of interest.

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