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

NCT ID: NCT04778826

Last Updated: 2021-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2023-03-01

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.

Conditions

Lung Neoplasm Malignant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Lung Lobectomy with standard ipsilateral lymphadenectomy

Lung lobectomy with ipsilateral lymphadenectomy

Group Type: ACTIVE_COMPARATOR

Lymphadenectomy

Intervention Type: PROCEDURE

radical bloc dissection of all mediastinal lymph node stations

Lung Lobectomy with VAMLA

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.

Group Type: ACTIVE_COMPARATOR

Lymphadenectomy

Intervention Type: PROCEDURE

radical bloc dissection of all mediastinal lymph node stations

Interventions

Lymphadenectomy

radical bloc dissection of all mediastinal lymph node stations

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Spine LLC

INDUSTRY

Sponsor Role: collaborator

Otto Wagner Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Salama

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Micheal Mueller, MD

Role: STUDY_DIRECTOR

Department of thoracic Surgery, Clinic Floridsdorf

Locations

Department of Thoracic Surgery, clinic Floridsdorf

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Mohamed SALAMA, MD, PhD

Role: CONTACT

mohamed.salama@meduniwien.ac.at

+4312770074221

Micheal Mueller, MD

Role: CONTACT

micheal.mueller@wienkav.at

+4312770074201

Facility Contacts

Mohamed Salama, MD, PhD

Role: primary

mohamed.salama@meduniwien.ac.at

Other Identifiers

combined Lobectomy and VAMLA

Identifier Type: -

Identifier Source: org_study_id