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

Not Applicable

• Conditions: Lung Neoplasm Malignant
• Interventions: Procedure: Lymphadenectomy

• Registration Number: NCT04778826
• Lead Sponsor: Otto Wagner Hospital

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.

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2020-10-15
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-02
• Last Update Submitted: 2021-03-02
• Study First Posted: 2021-03-03
• Last Update Posted: 2021-03-03
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lung Lobectomy with standard ipsilateral lymphadenectomy	Lymphadenectomy	Lung lobectomy with ipsilateral lymphadenectomy
Lung Lobectomy with VAMLA	Lymphadenectomy	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.

Primary Outcome Measures

Name	Time	Method
postoperative interleukins	1st postoperative day	Interleukin (IL) 6 serum concentration on the 1st postoperative day

Secondary Outcome Measures

Name	Time	Method
Hospitalisation	until discharge from hospital, assessed up to 14 days	Discharge from hospital
Overall Survival	5 years	5 years survival

Trial Locations

Locations (1)

Department of Thoracic Surgery, clinic Floridsdorf; 🇦🇹 Vienna, Austria