Role of Intrapulmonary Lymph Nodes in Patients With NSCLC and Visceral Pleural Invasion
Rekrutierend
NCT-Nummer:
NCT05596578
Studienbeginn:
Januar 2023
Letztes Update:
09.01.2023
Wirkstoff:
-
Indikation (Clinical Trials):
Lymphatic Metastasis
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
Luzerner Kantonsspital
Collaborator:
-
Kontakt
Fabrizio Minervini, MD, PhD
Kontakt:
Phone: +410412051111
E-Mail: fabriziominervini@hotmail.com» Kontaktdaten anzeigen
Brief Summary:
Background: Lung cancer is the leading cause of cancer related death worldwide. More than 80%
of all lung tumors are Non-Small Cell Lung Cancers (NSCLC). Lymph node staging has a
prognostic value and is crucial to establish the optimal treatment strategy in individual
patients. It remains unknown whether dissecting the intrapulmonary lymph nodes (stations 13
and 14) is necessary for accurate staging and prognostication. Although suggested by several
guidelines, these peripheral lymph nodes are not routinely examined in clinical routine for
several reasons. Moreover, the prognostic significance of the visceral pleural invasion is
controversial. Some studies showed a negative impact on OS and DFS in patients with
histologic proved visceral pleura invasion.
The mechanism to explain this negative effect is not fully understood. Given that the
visceral pleura is very rich in lymphatic vessels, with an intercommunicating "network"
arranged over the lung surface and penetrating into the lung parenchyma to join the bronchial
lymph vessels with drainage to the various hilar nodes, we assume that the worse OS and DFS
observed in these patients could be explained with the presence of metastatic lymph nodes
(Station 13-14) that are not routinely examined. Methods: This is a prospective, multicenter
study based on ad-hoc created prospectively database. The incidence of N1 lymph node
metastasis overall and the incidence of metastasis to the different lymph node stations
(Hilar 10/11, Lobar 12, Sublobar 13/14) will be calculated by dividing the number of the
respective events by the patient years separately. To investigate the association between
visceral pleural invasion and the presence of metastatic lymph nodes univariate and
multivariate logistic regression models will be fitted to the data.
Discussion: The primary outcome is to investigate the incidence of N1 metastases (especially
stations 12,13,14) and his relationship with visceral pleural invasion. The secondary
outcomes is to evaluate the impact of N1 metastases and/or visceral pleural invasion on
long-term outcomes (OS and DFS) along with incidence and pattern of recurrence. DFS is
defined as the time of surgical intervention to tumor recurrence or death, and OS is defined
as the time of surgical intervention to death
Inclusion Criteria:
- Anatomical resection for NSCLC <3 cm (lobectomy, bilobectomy, segmentectomy)
- Samples from the intrapulmonary stations 12, 13, and 14 lymph nodes
- Resection of lymphnodes station 10 and 11 during hilar separation.
- R0 resection
Exclusion Criteria:
- Prior or synchronous lung cancer
- pN2
- Pneumonectomy
- R1/R2 resection
- M1
- Neoadjuvant treatment
Primary outcome:
1. N1 (Time Frame - January 2023-December 2024):
Overall incidence of N1 pathological lymph nodes (Hilar 10/11, Lobar 12, Sublobar 13/14)
2. VPI (Time Frame - January 2023-December 2024):
Incidence of N1 pathological lymph nodes (Hilar 10/11, Lobar 12, Sublobar 13/14) in patients with pathological evidence of visceral pleural invasion
Secondary outcome:
1. OS (Time Frame - January 2023- December 2029):
Overall Survival (1-3-5 Years)
2. DFS (Time Frame - January 2023-December 2029):
Disease free survival (1-3-5 Years)
3. Tumor recurrence (Time Frame - January 2023-December 2029):
pattern : local, regional, distant
Quelle: ClinicalTrials.gov
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