Margin Status After Pancreaticoduodenectomy for Cancer

Margin Status After Pancreaticoduodenectomy for Cancer. Results of a Multicentric Prospective Randomized Trial

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 Overview

• Status: Completed
• Conditions: Pancreatic Cancer; Cholangiocarcinoma; Ampullary Cancer
• Intervention / Treatment: Diagnostic test: Leeds Pathology Protocol (LEEPP)

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Leeds Pathology Protocol (LEEPP)	Diagnostic test: Leeds Pathology Protocol (LEEPP); LEEPP includes: 1) multicolor inking; 2) axial slicing; 3) circumferential margin; 4) 1-mm clearance
No Intervention: Group B; "Conventional" method of pathological evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
R1 resection rate	To evaluate difference in terms of R1 resection rates between study groups with 0-mm and 1-mm clearance	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pathological data	To evaluate differences in pathological results (T status, N status, number of blocks, number of lymphnodes, etc) between the two study groups	1 month
oncological results	To evaluate the correlation between R1 resection and oncological results (local recurrence, overall survival) in the two study groups	60 months

Collaborators and Investigators

• Sponsor: Campus Bio-Medico University
• Collaborators: Azienda Ospedaliero, Universitaria Pisana; Medical University of Silesia; Humanitas Hospital, Italy

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: August 11, 2017
• First Submitted That Met QC Criteria: August 29, 2017
• First Posted (Actual): August 31, 2017

Study Record Updates

• Last Update Posted (Actual): February 6, 2020
• Last Update Submitted That Met QC Criteria: February 5, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: margin status; periampullary cancer; R1 resection; clearance margin
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Cholangiocarcinoma
• Other Study ID Numbers: NI 01/13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No