Lung Neoplasm MalignantNCT04778826
Immune Response Following Lobectomy Along With or Without Bilateral Transcervical Mediastinal Lymphadenectomy
A study testing Lymphadenectomy in people with Lung Neoplasm Malignant, run by Otto Wagner Hospital at 1 site in Austria.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasm Malignant
- What is being tested?
- Lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- 1 Oct 2020to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult
- non small cell lung cancer
- operable tumor
- indicated for endoscopic lung surgery
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Department of Thoracic Surgery, clinic Floridsdorf
Vienna, 1210
Mohamed Salama, MD, PhD, mohamed.salama@meduniwien.ac.at
About this study
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
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.
Read the 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.
- Conditions
- Lung Neoplasm Malignant
- Being tested
- Lymphadenectomy
- Keywords
- lung lobectomy, lymphadenectomy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LymphadenectomyProcedure or surgery
radical bloc dissection of all mediastinal lymph node stations
| Study group | Role | What they receive |
|---|---|---|
| Lung Lobectomy with standard ipsilateral lymphadenectomy | Active comparator | Lung lobectomy with ipsilateral lymphadenectomy Receives: Procedure: Lymphadenectomy |
| Lung Lobectomy with VAMLA | Active comparator | 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. Receives: Procedure: Lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative interleukins
Interleukin (IL) 6 serum concentration on the 1st postoperative day
Measured: 1st postoperative day
Secondary outcomes (2)
Hospitalisation
Discharge from hospital
Measured: until discharge from hospital, assessed up to 14 days
Overall Survival
5 years survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start1 Oct 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Neoplasm MalignantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otto Wagner Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic Spine LLC
- Responsible party
- Principal investigator, Mohamed Salama, Otto Wagner Hospital
- Investigators
- Micheal Mueller, MD, Study director, Department of thoracic Surgery, Clinic Floridsdorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778826
- Sponsor's protocol ID
- combined Lobectomy and VAMLA
- Status last verified
- Mar 2021
- First submitted
- 15 Oct 2020
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Salama M, Mueller MR. Enhanced recovery in lung surgery: coaxial versus conventional chest drains following video-assisted thoracoscopic surgery lobectomy-a prospective randomized trial. J Thorac Dis. 2025 Nov 30;17(11):10262-10271. doi: 10.21037/jtd-2025-1169. Epub 2025 Nov 26.
PubMed 41376917
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04778826
- Acronym / sponsor ID
- combined Lobectomy and VAMLA
- Conditions
- Lung Neoplasm Malignant
- Keywords
- lung lobectomy, lymphadenectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Otto Wagner HospitalUniversity, hospital or other
- Collaborators
- Medtronic Spine LLC
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Lung Lobectomy with standard ipsilateral lymphadenectomy | Active comparator | Procedure: LymphadenectomyLung lobectomy with ipsilateral lymphadenectomy |
| Lung Lobectomy with VAMLA | Active comparator | Procedure: LymphadenectomyLung 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult
- non small cell lung cancer
- operable tumor
- indicated for endoscopic lung surgery
Key exclusion criteria (1 listed)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lymphadenectomyradical bloc dissection of all mediastinal lymph node stations | Procedure or surgery | Lung Lobectomy with VAMLA, Lung Lobectomy with standard ipsilateral lymphadenectomy |
Primary outcome
postoperative interleukins
Time frame: 1st postoperative day
Interleukin (IL) 6 serum concentration on the 1st postoperative day
2 secondary outcomes
Hospitalisation
Time frame: until discharge from hospital, assessed up to 14 days
Overall Survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Derived from this study: PubMed 41376917Salama M, Mueller MR. Enhanced recovery in lung surgery: coaxial versus conventional chest drains following video-assisted thoracoscopic surgery lobectomy-a prospective randomized trial. J Thorac Dis. 2025 Nov 30;17(11):10262-10271. doi: 10.21037/jtd-2025-1169. Epub 2025 Nov 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Micheal Mueller, MD study director
Department of thoracic Surgery, Clinic Floridsdorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymphadenectomy in people with Lung Neoplasm Malignant, run by Otto Wagner Hospital at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed SALAMA, MD, PhD (+4312770074221, mohamed.salama@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative interleukins (time frame: 1st postoperative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04778826, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.