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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04778826
Other study ID # combined Lobectomy and VAMLA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date March 1, 2023

Study information

Verified date March 2021
Source Otto Wagner Hospital
Contact Mohamed SALAMA, MD, PhD
Phone +4312770074221
Email mohamed.salama@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 of 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date March 1, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - adult - non small cell lung cancer - operable tumor - indicated for endoscopic lung surgery Exclusion Criteria: - pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Austria Department of Thoracic Surgery, clinic Floridsdorf Vienna

Sponsors (2)

Lead Sponsor Collaborator
Otto Wagner Hospital Medtronic Spine LLC

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary postoperative interleukins Interleukin (IL) 6 serum concentration on the 1st postoperative day 1st postoperative day
Secondary Hospitalisation Discharge from hospital until discharge from hospital, assessed up to 14 days
Secondary Overall Survival 5 years survival 5 years
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