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Multicenter Study Clinical Trial
Prognostic Value of Resection Margin Involvement After Pancreaticoduodenectomy for Ductal Adenocarcinoma: Updates From a French Prospective Multicenter Study.
- Jean Robert Delpero, Florence Jeune, Philippe Bachellier, Nicolas Regenet, Yves Patrice Le Treut, Francois Paye, Nicolas Carrere, Alain Sauvanet, Mustapha Adham, Aurelie Autret, Flora Poizat, Olivier Turrini, and Jean Marie Boher.
- *Department of Surgery, Paoli-Calmettes Institute, Marseille, France †Department of Surgery, La Pitié-Salpêtrière - Université Pierre and Marie Curie, Paris VI, France ‡Department of Surgery, Hautepierre Hospital, University of Strasbourg, Strasbourg, France §Department of Surgery, Hotel Dieu Hospital, University of Nantes, Nantes, France ¶Department of Surgery, Hospital de la Conception, University of Aix-Marseille, Marseille, France ||Department of Surgery, Saint Antoine Hospital, University of Paris VI, Paris, France **Department of Surgery, Purpan Hospital, University of Toulouse Hospital Centre, Toulouse, France ††Department of Surgery, Beaujon Hospital, University of Paris VII, Clichy, France ‡‡Groupement Hospitalier Edouard Herriot, Université Claude Bernard Lyon 1, France §§Department of Histopathology, Paoli-Calmettes Institute, Marseille, France ¶¶Department of Biostatistics, Paoli-Calmettes Institute, Aix Marseille Univeristy, INSERM, IRD, SESSTIM, Marseille, France.
- Ann. Surg. 2017 Nov 1; 266 (5): 787-796.
ObjectiveThe aim of the study was to assess the relevance of resection margin status for survival after resection of pancreatic-head ductal adenocarcinoma.Summary Background DataThe definition and prognostic value of incomplete microscopic resection (R1) remain controversial.MethodsPrognostic factors were analyzed in 147 patients included in a prospective multicenter study on the impact of tumor clearance evaluated using a standardized pathology protocol.ResultsThirty patients received neoadjuvant treatment (NAT = 20%); 41 had venous resection (VR = 28%), and 70% received adjuvant chemotherapy. In-hospital mortality was 3% (5/147). Follow-up was 83 months. Tumor clearance was 0, <1.0, <1.5, and <2.0 mm in 35 (25%), 92 (65%), 95 (67%), and 109 (77%) patients, respectively. R0-resection rates decreased from 75% to 35% when changing the definition of R1 status from R1-direct invasion (0 mm) to R1 <1.0 mm. On univariate analysis, clearance <1.0 or <1.5 mm, pT stage, pN stage, LNR ≥0.2, tumor grade 3, and lymphovascular invasion were significantly associated with 5-year survival. On multivariate analysis, pN was the most powerful independent predictor (P = 0.004). Clearance <1.0 or <1.5 mm had borderline significance for the entire cohort, but was relevant in certain subgroups (upfront pancreatectomy (n = 117; P = 0.049); without VR or NAT (n = 87; P = 0.003); N+ without VR or NAT (n = 50; P = 0.004). No N0-patient had R1-0 mm. Additional independent risk predictors were (1) R1 <1.0 mm for the SMA-margin in specific subgroups (upfront pancreatectomy, N0 patients without NAT, N+ patients without NAT or VR; (2) R1-0 mm posterior-margin for the NAT group (P = 0.004).ConclusionTumor clearance <1.0 or <1.5 mm was an independent determinants of postresection survival in certain subgroups. To avoid misinterpretation, future trials should specify the clearance margin in millimeter.Trial RegistrationClinicalTrials.gov: NCT00918853.
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