Margin Status After Pancreaticoduodenectomy for Cancer

Sponsor

Campus Bio-Medico University (Other)

Overall Status

Completed

CT.gov ID

NCT03267966

Collaborator

Humanitas Hospital, Italy (Other), Azienda Ospedaliero, Universitaria Pisana (Other), Medical University of Silesia (Other)

168

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer Cholangiocarcinoma Ampullary Cancer	Diagnostic Test: Leeds Pathology Protocol (LEEPP)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

168 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Campus Bio-Medico University
Humanitas Hospital, Italy
Azienda Ospedaliero, Universitaria Pisana
Medical University of Silesia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gennaro Nappo, M.D., Campus Bio-Medico University

ClinicalTrials.gov Identifier:

NCT03267966

Other Study ID Numbers:

NI 01/13

First Posted:

Aug 31, 2017

Last Update Posted:

Feb 6, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gennaro Nappo, M.D., Campus Bio-Medico University

Additional relevant MeSH terms:

Cholangiocarcinoma

Study Results

No Results Posted as of Feb 6, 2020