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.本数据集关联论文为《壶腹周围癌胰十二指肠切除术（Pancreatoduodenectomy, PD）后切缘状态评估中病理方法与切缘定义的作用——一项多中心前瞻性随机试验结果》。背景：现有关于壶腹周围癌胰十二指肠切除术后R1切除（R1 resection）率判定的相关文献存在极强异质性，因此其预后价值仍存在争议。本项多中心随机对照研究的目的在于：一是评估取样方式与切缘定义对壶腹周围癌胰十二指肠切除术后R1切除率判定的影响；二是评估R1切除的预后价值。方法：将胰十二指肠切除标本随机分为两组，A组采用利兹病理方案（Leeds Pathology Protocol, LEEPP），B组采用本研究开展前的常规病理方法。分别以0mm和1mm切缘标准判定R1切除率，并评估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0mm切缘判定时，A、B两组的R1切除率分别为26.2%与20.2%；以1mm切缘判定时，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影响因素：以0mm切缘判定时，R0切除（R0 resection）与R1切除患者的中位总生存期分别为36个月与20个月；以1mm切缘判定时，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显著预后影响因素。结论：1mm切缘标准是判定胰十二指肠切除术后R1切除率的最具区分度的因素。然而，病理检测方法对于准确评估R1切除的预后价值至关重要：仅采用利兹病理方案获得的R1切除标本，其预后影响才具有统计学显著性。