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

Study Overview
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Brief Summary
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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
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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: 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. 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. 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.

Official Title
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Immune Response of Patients Following Thoracoscopic Lobectomy Along With Bilateral Transcervical Mediastinal Lymphadenectomy and Patients Receiving VATSLOB Together With Standard Unilateral Mediastinal Lymphadenectomy

Conditions
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Lung Neoplasm Malignant

Intervention / Treatment
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* Procedure: Lymphadenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult non small cell lung cancer operable tumor indicated for endoscopic lung surgery Exclusion Criteria: pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lung Lobectomy with standard ipsilateral lymphadenectomy<br>Lung lobectomy with ipsilateral lymphadenectomy | Procedure: Lymphadenectomy<br>* radical bloc dissection of all mediastinal lymph node stations<br>|
| Active Comparator: Lung Lobectomy with VAMLA<br>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. | Procedure: Lymphadenectomy<br>* radical bloc dissection of all mediastinal lymph node stations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative interleukins | Interleukin (IL) 6 serum concentration on the 1st postoperative day | 1st postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalisation | Discharge from hospital | until discharge from hospital, assessed up to 14 days | 
| Overall Survival | 5 years survival | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung lobectomy, lymphadenectomy