Dataset related to article "The Role of Pathological Method and Clearance Definition for the Evaluation of Margin Status after Pancreatoduodenectomy for Periampullary Cancer. Results of a Multicenter Prospective Randomized Trial."

This record contains data related to article "The Role of Pathological Method and Clearance Definition for the Evaluation of Margin Status after Pancreatoduodenectomy for Periampullary Cancer. Results of a Multicenter Prospective Randomized Trial."

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; to assess the prognostic role of R1 resection.

Methods: PD specimens were randomized to Leeds Pathology Protocol (LEEPP) (group A) or conventional method adopted before the study (group B). R1 rate was determined 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, R1 was 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 as a significant prognostic factor independent of clearance definition only in case of adoption of LEEPP.

Conclusions. The 1 mm clearance is the most effective factor in determining 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.