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Completed

NCT Number: NCT03267966

Margin Status After Pancreaticoduodenectomy for Cancer

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.

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Key information

Conditions

Pancreatic Cancer Adenocarcinoma Ampullary Cancer Carcinoma Cholangiocarcinoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Leeds Pathology Protocol (LEEPP)

Diagnostic Test

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

Primary outcomes

  1. R1 resection rate

    Time frame: 1 month

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

Secondary outcomes

  1. pathological data

    Time frame: 1 month

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

  2. oncological results

    Time frame: 60 months

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

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Collaborators

  • Azienda Ospedaliero, Universitaria Pisana
  • Humanitas Hospital, Italy
  • Medical University of Silesia

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2019
First posted
Aug 31, 2017
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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