Gennaro Nappo1, Domenico Borzomati2, Alessandro Zerbi1,3, Paola Spaggiari4, Ugo Boggi4,5, Daniela Campani6, Sławomir Mrowiec7, Łukasz Liszka8, Alessandro Coppola2, Michela Amato9, Tommasangelo Petitti10, Fabio Vistoli4,5, Marco Montorsi3,11, Giuseppe Perrone9, Roberto Coppola2, Damiano Caputo2. 1. Pancreatic Surgery Unit, Humanitas Clinical and Research Center-IRCCS, Via Manzoni 56, 20089 Rozzano, Italy. 2. Department of Surgery, Università Campus Bio-Medico di Roma, 00128 Rome, Italy. 3. Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20090 Milan, Italy. 4. Pathology Unit, Humanitas Clinical and Research Center-IRCCS, Via Manzoni 56, 20089 Rozzano, Italy. 5. Division of General and Transplant Surgery, Azienda Ospedaliero-Universitaria Pisana, University of Pisa, 56126 Pisa, Italy. 6. Pathology Unit, Azienda Ospedaliero-Universitaria Pisana, University of Pisa, 56126 Pisa, Italy. 7. Department of Gastrointestinal Surgery, Medical University of Silesia, 40-055 Katowice, Poland. 8. Department of Pathomorphology and Molecular Diagnostics, Medical University of Silesia, 40-055 Katowice, Poland. 9. Pathology Unit, Campus Bio-Medico University of Rome, 00128 Rome, Italy. 10. Department of Public Health, Hygiene and Statistics, Campus Bio-Medico University of Rome, 00128 Rome, Italy. 11. Department of Surgery, Humanitas Clinical and Research Center-IRCCS, Via Manzoni 56, 20089 Rozzano, Italy.
Abstract
BACKGROUND: There is extreme heterogeneity in the available literature on the determination of R1 resection rate after pancreatoduodenectomy (PD); consequently, its prognostic role is still debated. The aims of this multicenter randomized study were to evaluate the effect of sampling and clearance definition in determining R1 rate after PD for periampullary cancer and to assess the prognostic role of R1 resection. METHODS: PD specimens were randomized to Leeds Pathology Protocol (LEEPP) (group A) or the conventional method adopted before the study (group B). R1 rate was determined by adopting 0- and 1-mm clearance; the association between R1, local recurrence (LR) and overall survival (OS) was also evaluated. RESULTS:One-hundred-sixty-eight PD specimens were included. With 0 mm clearance, R1 rate was 26.2% and 20.2% for groups A and B, respectively; with 1 mm, R1 rate was 60.7% and 57.1%, respectively (p > 0.05). Only in group A was R1 found to be a significant prognostic factor: at 0 mm, median OS was 36 and 20 months for R0 and R1, respectively, while at 1 mm, median OS was not reached and 30 months. At multivariate analysis, R1 resection was found to be a significant prognostic factor independent of clearance definition only in the case of the adoption of LEEPP. CONCLUSIONS: The 1 mm clearance is the most effective factor in determining the R1 rate after PD. However, the pathological method is crucial to accurately evaluate its prognostic role: only R1 resections obtained with the adoption of LEEPP seem to significantly affect prognosis.
RCT Entities:
BACKGROUND: There is extreme heterogeneity in the available literature on the determination of R1 resection rate after pancreatoduodenectomy (PD); consequently, its prognostic role is still debated. The aims of this multicenter randomized study were to evaluate the effect of sampling and clearance definition in determining R1 rate after PD for periampullary cancer and to assess the prognostic role of R1 resection. METHODS:PD specimens were randomized to Leeds Pathology Protocol (LEEPP) (group A) or the conventional method adopted before the study (group B). R1 rate was determined by adopting 0- and 1-mm clearance; the association between R1, local recurrence (LR) and overall survival (OS) was also evaluated. RESULTS: One-hundred-sixty-eight PD specimens were included. With 0 mm clearance, R1 rate was 26.2% and 20.2% for groups A and B, respectively; with 1 mm, R1 rate was 60.7% and 57.1%, respectively (p > 0.05). Only in group A was R1 found to be a significant prognostic factor: at 0 mm, median OS was 36 and 20 months for R0 and R1, respectively, while at 1 mm, median OS was not reached and 30 months. At multivariate analysis, R1 resection was found to be a significant prognostic factor independent of clearance definition only in the case of the adoption of LEEPP. CONCLUSIONS: The 1 mm clearance is the most effective factor in determining the R1 rate after PD. However, the pathological method is crucial to accurately evaluate its prognostic role: only R1 resections obtained with the adoption of LEEPP seem to significantly affect prognosis.
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