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

NCT04778826 | Unknown

• 1 other identifier: combined Lobectomy and VAMLA
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasm Malignant

Keywords

lung lobectomy; lymphadenectomy

Outcome Measures

Primary Outcomes (1)

• postoperative interleukins

  Interleukin (IL) 6 serum concentration on the 1st postoperative day

  1st postoperative day

Secondary Outcomes (2)

• Hospitalisation

  until discharge from hospital, assessed up to 14 days

• Overall Survival

  5 years

Study Arms (2)

Lung Lobectomy with standard ipsilateral lymphadenectomy

ACTIVE COMPARATOR

Lung lobectomy with ipsilateral lymphadenectomy

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.

Procedure: Lymphadenectomy

Interventions

Lymphadenectomy PROCEDURE

radical bloc dissection of all mediastinal lymph node stations

Lung Lobectomy with VAMLA; Lung Lobectomy with standard ipsilateral lymphadenectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• pregnancy

Sponsors & Collaborators

• Otto Wagner Hospital: lead
• Medtronic Spine LLC: collaborator

Study Sites (1)

Department of Thoracic Surgery, clinic Floridsdorf

Vienna, 1210, Austria

RECRUITING

Related Publications (1)

• 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.

  PMID: 41376917 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Lymph Node Excision

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Micheal Mueller, MD

  Department of thoracic Surgery, Clinic Floridsdorf

  STUDY DIRECTOR

Central Study Contacts

Mohamed SALAMA, MD, PhD

CONTACT

+4312770074221; mohamed.salama@meduniwien.ac.at

Micheal Mueller, MD

CONTACT

+4312770074201; micheal.mueller@wienkav.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: March 3, 2021
• Study Start: October 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: March 1, 2023
• Last Updated: March 3, 2021

Record last verified: 2021-03

Locations

AU (1)