Margin Status After Pancreaticoduodenectomy for Cancer

NCT ID: NCT03267966

Last Updated: 2020-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatic Cancer Cholangiocarcinoma Ampullary Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A

Leeds Pathology Protocol (LEEPP)

Group Type EXPERIMENTAL

Leeds Pathology Protocol (LEEPP)

Intervention Type DIAGNOSTIC_TEST

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

Group B

"Conventional" method of pathological evaluation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Leeds Pathology Protocol (LEEPP)

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Humanitas Hospital, Italy

OTHER

Sponsor Role collaborator

Azienda Ospedaliero, Universitaria Pisana

OTHER

Sponsor Role collaborator

Medical University of Silesia

OTHER

Sponsor Role collaborator

Campus Bio-Medico University

OTHER

Sponsor Role lead

Responsible Party

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Gennaro Nappo

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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NI 01/13

Identifier Type: -

Identifier Source: org_study_id

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