Margin Status After Pancreaticoduodenectomy for Cancer

Campus Bio-Medico University168 enrolled

Overview

This multicentric prospective randomized controlled trial (RCT) compares the Leeds Pathology Protocol (LEEPP) with other "conventional" pathological protocol of PD specimen for periampullary cancer. Our aims were to evaluate the impact of the protocol and of the clearance on R1 rate and its prognostic value.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

168

Conditions

Pancreatic Cancer Cholangiocarcinoma Ampullary Cancer

Interventions

Leeds Pathology Protocol (LEEPP)DIAGNOSTIC_TEST

LEEPP includes: 1) multicolor inking; 2) axial slicing; 3) circumferential margin; 4) 1-mm clearance

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * pancreaticoduodenectomy for periampullary cancer Exclusion Criteria: * diagnosis of neuroendocrine neoplasm; * previous pancreatic surgery; * frozen section of each transection margins not performed or presence of positive transection margins without further resection (R1 intraoperative resection); * presence of macroscopic residual tumor (R2 resection).

Outcomes

Primary Outcomes

R1 resection rate

To evaluate difference in terms of R1 resection rates between study groups with 0-mm and 1-mm clearance

Time frame: 1 month

Secondary Outcomes

pathological data

To evaluate differences in pathological results (T status, N status, number of blocks, number of lymphnodes, etc) between the two study groups

Time frame: 1 month

oncological results

To evaluate the correlation between R1 resection and oncological results (local recurrence, overall survival) in the two study groups

Time frame: 60 months

Data from ClinicalTrials.gov

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