Clinical trial NCT06135649: Dissecting the Pattern of Nodal Spread in Post-neoadjuvant Pancreatoduodenectomy
Official title: A Prospective Lymphadenectomy Protocol to Investigate the Pattern of Nodal Spread and Its Association With Oncologic Outcomes in Post-neoadjuvant Pancreatoduodenectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreas Cancer
Pancreatic Adenocarcinoma
Keywords: Pancreatoduodenectomy
Lymphadenectomy
Lymph nodes
Pancreatic cancer
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 850
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Metastatic involvement of second nodal echelon
timeFrame: 3 years
Secondary outcomes:
measure: Metastatic involvement of single nodal stations
timeFrame: 8 years
measure: Overall survival
timeFrame: 3 years
measure: Recurrence-free survival
timeFrame: 3 years
measure: Overall survival
timeFrame: 8 years
measure: Recurrence-free survival
timeFrame: 8 years
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Unit of Pancreatic Surgery - G.B. Rossi Hospital, University of Verona Hospital Trust
state: VR
Study officials:
References:
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.
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.
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.
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.
citation: 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.