Dissecting the Pattern of Nodal Spread in Post-neoadjuvant Pancreatoduodenectomy

Pancreas Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06135649
• Other study ID #: LN_NAT
• Status: Recruiting
• Start date: January 2013
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Universita di Verona
• Contact: Giuseppe Malleo, MD PhD
• Phone: 00390458126008
• Email: giuseppe.malleo[@]aovr.veneto.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 850
• Est. completion date: December 2024
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Adenocarcinoma
• Pancreatic Neoplasms

Intervention

Procedure:
• Systematic lymphadenectomy
The nodal dissection protocol included the ISGPS lymphadenectomy stations (5, 6, 8a, 12b-c, 13, 14a-b, and 17) extended to stations contiguous to the regional basin (8p, 12a-p, and jejunal mesentery nodes). Stations embedded in the PD specimen (13, 14a-b, 17 and jejunal mesentery LN) were defined as first nodal echelon, while stations sampled as distinct specimens (5, 6, 8a-p, 12a-b-p-c) were defined as second nodal echelon.

Locations

Country	Name	City	State
Italy	Unit of Pancreatic Surgery - G.B. Rossi Hospital, University of Verona Hospital Trust	Verona	VR

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metastatic involvement of second nodal echelon	Rate of metastases to nodes outside the main resection specimen (stations 6,8,12)	3 years
Secondary	Metastatic involvement of single nodal stations	Rate of metastases in each station included in the lymphadenectomy protocol	8 years
Secondary	Overall survival	Overall survival from pancreatectomy stratified by nodal echelon	3 years
Secondary	Recurrence-free survival	Recurrence-free survival from pancreatectomy stratified by nodal echelon	3 years
Secondary	Overall survival	Overall survival from pancreatectomy stratified by nodal stations	8 years
Secondary	Recurrence-free survival	Recurrence-free survival from pancreatectomy stratified by nodal stations	8 years