NCT03267966

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable pancreatic-cancer

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable pancreatic-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

2.3 years

First QC Date

August 11, 2017

Last Update Submit

February 5, 2020

Conditions

Pancreatic CancerCholangiocarcinomaAmpullary Cancer

Keywords

periampullary cancermargin statusR1 resectionclearance margin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • pathological data

    1 month

  • oncological results

    60 months

Study Arms (2)

Group A

EXPERIMENTAL

Leeds Pathology Protocol (LEEPP)

Diagnostic Test: Leeds Pathology Protocol (LEEPP)

Group B

NO INTERVENTION

"Conventional" method of pathological evaluation

Interventions

Leeds Pathology Protocol (LEEPP)DIAGNOSTIC_TEST

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

Group A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pancreaticoduodenectomy for periampullary cancer

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatic NeoplasmsCholangiocarcinoma

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

August 11, 2017

First Posted

August 31, 2017

Study Start

March 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2019

Last Updated

February 6, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share