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

Lung Neoplasm Malignant Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04778826
• Other study ID #: combined Lobectomy and VAMLA
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Lung Neoplasm Malignant
• Lung Neoplasms
• Neoplasms

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