- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06135649
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
- Name: Giuseppe Malleo, MD PhD
- Phone Number: 00390458126008
- Email: giuseppe.malleo@aovr.veneto.it
Study Locations
-
-
VR
-
Verona, VR, Italy, 37134
- Recruiting
- Unit of Pancreatic Surgery - G.B. Rossi Hospital, University of Verona Hospital Trust
-
Contact:
- Giuseppe Malleo, MD PhD
- Phone Number: 00390458126008
- Email: giuseppe.malleo@aovr.veneto.it
-
-
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
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
- Malleo G, Maggino L, Capelli P, Gulino F, Segattini S, Scarpa A, Bassi C, Butturini G, Salvia R. Reappraisal of Nodal Staging and Study of Lymph Node Station Involvement in Pancreaticoduodenectomy with the Standard International Study Group of Pancreatic Surgery Definition of Lymphadenectomy for Cancer. J Am Coll Surg. 2015 Aug;221(2):367-79.e4. doi: 10.1016/j.jamcollsurg.2015.02.019. Epub 2015 Feb 28.
- Malleo G, Maggino L, Casciani F, Lionetto G, Nobile S, Lazzarin G, Paiella S, Esposito A, Capelli P, Luchini C, Scarpa A, Bassi C, Salvia R. Importance of Nodal Metastases Location in Pancreatoduodenectomy for Pancreatic Ductal Adenocarcinoma: Results from a Prospective, Lymphadenectomy Protocol. Ann Surg Oncol. 2022 Jun;29(6):3477-3488. doi: 10.1245/s10434-022-11417-3. Epub 2022 Feb 21.
- Malleo G, Maggino L, Qadan M, Marchegiani G, Ferrone CR, Paiella S, Luchini C, Mino-Kenudson M, Capelli P, Scarpa A, Lillemoe KD, Bassi C, Castillo CF, Salvia R. Reassessment of the Optimal Number of Examined Lymph Nodes in Pancreatoduodenectomy for Pancreatic Ductal Adenocarcinoma. Ann Surg. 2022 Nov 1;276(5):e518-e526. doi: 10.1097/SLA.0000000000004552. Epub 2020 Nov 9.
- Javed AA, Ding D, Baig E, Wright MJ, Teinor JA, Mansoor D, Thompson E, Hruban RH, Narang A, Burns WR 3rd, Burkhart RA, Lafaro K, Weiss MJ, Cameron JL, Wolfgang CL, He J. Accurate Nodal Staging in Pancreatic Cancer in the Era of Neoadjuvant Therapy. World J Surg. 2022 Mar;46(3):667-677. doi: 10.1007/s00268-021-06410-y. Epub 2022 Jan 7.
- Arrington AK, O'Grady C, Schaefer K, Khreiss M, Riall TS. Significance of Lymph Node Resection After Neoadjuvant Therapy in Pancreatic, Gastric, and Rectal Cancers. Ann Surg. 2020 Sep 1;272(3):438-446. doi: 10.1097/SLA.0000000000004181.
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
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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