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.

本数据集收录与论文《壶腹周围癌胰十二指肠切除术后切缘状态评估的病理方法与切缘定义：多中心前瞻性随机试验结果》相关的研究数据。

背景：现有关于胰十二指肠切除术（pancreatoduodenectomy, PD）后R1切除率（R1 resection rate）测定的相关文献存在显著异质性，因此其预后作用仍存在广泛争议。本项多中心随机研究的目标为：评估取材方式与切缘定义对壶腹周围癌患者行PD后R1切除率测定的影响，并评价R1切除的预后价值。

方法：将胰十二指肠切除标本随机分配至利兹病理方案（Leeds Pathology Protocol, LEEPP）组（A组）与本研究实施前采用的常规方法组（B组）。分别以0 mm和1 mm切缘标准测定R1切除率，同时分析R1切除与局部复发（local recurrence, LR）、总生存期（overall survival, OS）之间的关联。

结果：本研究共纳入168例胰十二指肠切除标本。以0 mm切缘标准时，A组与B组的R1切除率分别为26.2%与20.2%；以1 mm切缘标准时，两组R1切除率分别为60.7%与57.1%（p > 0.05）。仅在A组中，R1切除被证实为具有统计学意义的预后因素：以0 mm切缘标准时，R0与R1切除患者的中位总生存期分别为36个月与20个月；以1 mm切缘标准时，R0切除患者的中位总生存期未达到，而R1切除患者为30个月。多因素分析显示，仅当采用利兹病理方案时，R1切除才是独立于切缘定义的具有统计学意义的预后因素。

结论：1 mm切缘标准是影响PD术后R1切除率测定的最关键因素。然而，病理检测方法对于准确评估其预后价值至关重要：仅采用利兹病理方案获得的R1切除标本，才可对患者预后产生显著影响。