Sonntag, 13. Juni 2021
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JOURNAL ONKOLOGIE – STUDIE

Immune Response Following Lobectomy Along With or Without Bilateral Transcervical Mediastinal Lymphadenectomy

Rekrutierend

NCT-Nummer:
NCT04778826

Studienbeginn:
Oktober 2020

Letztes Update:
03.03.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Lung Neoplasms, Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Otto Wagner Hospital

Collaborator:
Medtronic Spine LLC

Studienleiter

Micheal Mueller, MD
Study Director
Department of thoracic Surgery, Clinic Floridsdorf

Kontakt

Studienlocations
(1 von 1)

Studien-Informationen

Detailed Description:

Any kind of anatomical lung resection for lung cancer with curative intent has to be

accompanied by formal mediastinal lymph node dissection. Video-assisted mediastinoscopic

lymphadenectomy through a cervical access (VAMLA) along with thoracoscopic lobectomies in the

same setting offers improved radicality through bilateral mediastinal dissection, provide

accurate staging, does not require single lung ventilation and hence ideally supports the

concept of minimally invasive surgery.

Due to the VAMLA associated radicality, the investigator believes that using VAMLA along with

lobectomy could improve the oncological outcome of lung cancer patients. Furthermore, the

absence of single lung ventilation during VAMLA could attenuate the surgically induced

immunosuppression.

The present study aims at:

1. The current project primarily aims at identifying the effect of reduced single lunge

ventilation time during VAMLA-VATS lobectomy on the intraoperative production of oxygen

radicals as well as its effect on the immune competence of patients undergoing

VAMLA-VATS lobectomy as compared to those receiving VATS lobectomy Along with

conventional unilateral lymphadenectomy.

2. Secondary, in line with the hypothesis that radical bilateral lymphadenectomy might

results in a more complete oncological staging as compared to unilateral lymphadenectomy

or lymph node sampling. The current project aims to compare the pre- and postoperative

staging in patients undergoing VAMLA, as VAMLA enables a proper examination of all

bilateral mediastinal lymph nodes.

3. Patient Follow-up will be continued for at least 5 years postoperatively in order to

compare the oncological outcome namely local and distant recurrence, tumor-associated

and overall survival in patients undergoing VAMLA-VATS Lobectomy as compared to those

with VATS lobectomy. This issue is, however, a second endpoint of this study and will be

independent of the primary endpoint.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- adult

- non small cell lung cancer

- operable tumor

- indicated for endoscopic lung surgery

Exclusion Criteria:

- pregnancy

Studien-Rationale

Primary outcome:

1. postoperative interleukins (Time Frame - 1st postoperative day):
Interleukin (IL) 6 serum concentration on the 1st postoperative day



Secondary outcome:

1. Hospitalisation (Time Frame - until discharge from hospital, assessed up to 14 days):
Discharge from hospital

2. Overall Survival (Time Frame - 5 years):
5 years survival

Studien-Arme

  • Active Comparator: Lung Lobectomy with standard ipsilateral lymphadenectomy
    Lung lobectomy with ipsilateral lymphadenectomy
  • Active Comparator: Lung Lobectomy with VAMLA
    Lung lobectomy combined with video-assisted mediastinal lymphadenectomy through the neck (VAMLA). The approach is similar to transcervical mediastinoscopy and allows for a radical bloc dissection of all mediastinal lymph node stations. Besides the benefit of bilateral lung ventilation during this phase of the operation a bilateral mediastinal lymphadenectomy offers improved surgical radicality.

Geprüfte Regime

  • Lymphadenectomy:
    radical bloc dissection of all mediastinal lymph node stations

Quelle: ClinicalTrials.gov


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