Dissecting the Pattern of Nodal Spread in Post-neoadjuvant Pancreatoduodenectomy

November 15, 2023 updated by: Giuseppe Malleo, Universita di Verona

A Prospective Lymphadenectomy Protocol to Investigate the Pattern of Nodal Spread and Its Association With Oncologic Outcomes in Post-neoadjuvant Pancreatoduodenectomy

There has been long-standing debate about nodal dissection in pancreatoduodenectomy (PD) for pancreatic ductal adenocarcinoma (PDAC), with most studies examining the value of nodal yields, number of metastatic nodes and spatial location of metastases being conducted in the upfront surgery setting. With increasing use of a chemotherapy-first approach even in early stage PDAC, the validity of nodal parameters in post-treatment PD has been brought into question due to therapy-induced lymph node (LN) shrinkage. However, the available information is based on retrospective data or administrative registries, which only considered the number of examined and metastatic nodes, without detailed information regarding the dissection protocol and the influence of nodal metastases location. Back in 2013, corresponding to the standard lymphadenectomy definition release by the International Study Group of Pancreatic Surgery (ISGPS) and the diffusion of multi-agent chemotherapy regimens, an institutional, station-based nodal dissection protocol was established for post-neoadjuvant PD. The aim was to investigate whether the pattern of metastatic spread within the nodal basin is a superior quality metric for prognosis relative to the count-based classification system.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

850

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • VR
      • Verona, VR, Italy, 37134
        • Recruiting
        • Unit of Pancreatic Surgery - G.B. Rossi Hospital, University of Verona Hospital Trust
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients with localized pancreatic ductal adenocarcinoma receiving post-neoadjuvant pancreatoduodenectomy from June 2013were eligible for inclusion in the study.

Description

Inclusion Criteria:

  • Post-neoadjuvant pancreatoduodenectomy for localized pancreatic ductal adenocarcinoma.

Exclusion Criteria:

  • Oligometastatic disease
  • Upfront pancreatectomy
  • Incomplete lymphadenectomy
  • Macroscopically incomplete resections
  • Rare variants of pancreatic cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metastatic involvement of second nodal echelon
Time Frame: 3 years
Rate of metastases to nodes outside the main resection specimen (stations 6,8,12)
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metastatic involvement of single nodal stations
Time Frame: 8 years
Rate of metastases in each station included in the lymphadenectomy protocol
8 years
Overall survival
Time Frame: 3 years
Overall survival from pancreatectomy stratified by nodal echelon
3 years
Recurrence-free survival
Time Frame: 3 years
Recurrence-free survival from pancreatectomy stratified by nodal echelon
3 years
Overall survival
Time Frame: 8 years
Overall survival from pancreatectomy stratified by nodal stations
8 years
Recurrence-free survival
Time Frame: 8 years
Recurrence-free survival from pancreatectomy stratified by nodal stations
8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universita di Verona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

December 1, 2019

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 12, 2023

First Submitted That Met QC Criteria

November 15, 2023

First Posted (Estimated)

November 16, 2023

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LN_NAT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data will be available upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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