Immune Response Following Lobectomy Along With or Without Bilateral Transcervical Mediastinal Lymphadenectomy
Primary Purpose
Lung Neoplasm Malignant
Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Lymphadenectomy
Sponsored by
About this trial
This is an interventional basic science trial for Lung Neoplasm Malignant focused on measuring lung lobectomy, lymphadenectomy
Eligibility Criteria
Inclusion Criteria:
- adult
- non small cell lung cancer
- operable tumor
- indicated for endoscopic lung surgery
Exclusion Criteria:
- pregnancy
Sites / Locations
- Department of Thoracic Surgery, clinic FloridsdorfRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Lung Lobectomy with standard ipsilateral lymphadenectomy
Lung Lobectomy with VAMLA
Arm Description
Lung lobectomy with ipsilateral 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.
Outcomes
Primary Outcome Measures
postoperative interleukins
Interleukin (IL) 6 serum concentration on the 1st postoperative day
Secondary Outcome Measures
Hospitalisation
Discharge from hospital
Overall Survival
5 years survival
Full Information
NCT ID
NCT04778826
First Posted
October 15, 2020
Last Updated
March 2, 2021
Sponsor
Otto Wagner Hospital
Collaborators
Medtronic Spine LLC
1. Study Identification
Unique Protocol Identification Number
NCT04778826
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Otto Wagner Hospital
Collaborators
Medtronic Spine LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasm Malignant
Keywords
lung lobectomy, lymphadenectomy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lung Lobectomy with standard ipsilateral lymphadenectomy
Arm Type
Active Comparator
Arm Description
Lung lobectomy with ipsilateral lymphadenectomy
Arm Title
Lung Lobectomy with VAMLA
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Lymphadenectomy
Intervention Description
radical bloc dissection of all mediastinal lymph node stations
Primary Outcome Measure Information:
Title
postoperative interleukins
Description
Interleukin (IL) 6 serum concentration on the 1st postoperative day
Time Frame
1st postoperative day
Secondary Outcome Measure Information:
Title
Hospitalisation
Description
Discharge from hospital
Time Frame
until discharge from hospital, assessed up to 14 days
Title
Overall Survival
Description
5 years survival
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult
non small cell lung cancer
operable tumor
indicated for endoscopic lung surgery
Exclusion Criteria:
pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed SALAMA, MD, PhD
Phone
+4312770074221
Email
mohamed.salama@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Micheal Mueller, MD
Phone
+4312770074201
Email
micheal.mueller@wienkav.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Micheal Mueller, MD
Organizational Affiliation
Department of thoracic Surgery, Clinic Floridsdorf
Official's Role
Study Director
Facility Information:
Facility Name
Department of Thoracic Surgery, clinic Floridsdorf
City
Vienna
ZIP/Postal Code
1210
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Salama, MD, PhD
Email
mohamed.salama@meduniwien.ac.at
12. IPD Sharing Statement
Learn more about this trial
Immune Response Following Lobectomy Along With or Without Bilateral Transcervical Mediastinal Lymphadenectomy
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