Clinical trial NCT04778826: Immune Response Following Lobectomy Along With or Without Bilateral Transcervical Mediastinal Lymphadenectomy
Official title: Immune Response of Patients Following Thoracoscopic Lobectomy Along With Bilateral Transcervical Mediastinal Lymphadenectomy and Patients Receiving VATSLOB Together With Standard Unilateral Mediastinal Lymphadenectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Neoplasm Malignant
Keywords: lung lobectomy
lymphadenectomy
Lead sponsor: Otto Wagner Hospital
Sponsor class: OTHER
Collaborators: name: Medtronic Spine LLC
First posted: 2021-03-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Compare the oncological outcome and immune competence between patients who undergo lung lobectomy with standard lymphadenectomy and those who undergo combined lobectomy and video assisted bilateral mediastinal lymphadenectomy
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* adult
* non small cell lung cancer
* operable tumor
* indicated for endoscopic lung surgery

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: postoperative interleukins
timeFrame: 1st postoperative day
Secondary outcomes:
measure: Hospitalisation
timeFrame: until discharge from hospital, assessed up to 14 days
measure: Overall Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Thoracic Surgery, clinic Floridsdorf
Study officials:
affiliation: Department of thoracic Surgery, Clinic Floridsdorf
name: Micheal Mueller, MD
role: STUDY_DIRECTOR
References: