Dissecting the Pattern of Nodal Spread in Post-neoadjuvant Pancreatoduodenectomy

NCT06135649 | Unknown

• 1 other identifier: LN_NAT
• Study Type: observational
• Target: 850
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreas Cancer; Pancreatic Adenocarcinoma

Keywords

Pancreatoduodenectomy; Lymphadenectomy; Lymph nodes; Pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Metastatic involvement of second nodal echelon

  Rate of metastases to nodes outside the main resection specimen (stations 6,8,12)

  3 years

Secondary Outcomes (5)

• Metastatic involvement of single nodal stations

  8 years

• Overall survival

  3 years

• Recurrence-free survival

  3 years

• Overall survival

  8 years

• Recurrence-free survival

  8 years

Interventions

Systematic lymphadenectomy PROCEDURE

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Post-neoadjuvant pancreatoduodenectomy for localized pancreatic ductal adenocarcinoma.

You may not qualify if:

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

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Unit of Pancreatic Surgery - G.B. Rossi Hospital, University of Verona Hospital Trust

Verona, VR, 37134, Italy

RECRUITING

Related Publications (5)

• 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.

  PMID: 26081176 BACKGROUND

• 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.

  PMID: 35192154 BACKGROUND

• 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.

  PMID: 33177357 BACKGROUND

• 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.

  PMID: 34994834 BACKGROUND

• 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.

  PMID: 32740236 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Giuseppe Malleo, MD PhD

CONTACT

00390458126008; giuseppe.malleo@aovr.veneto.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: November 12, 2023
• First Posted: November 18, 2023
• Study Start: January 1, 2013
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

IT (1)