Lymph Node DissectionLNDNSCLC-RUSNCT07401498
Complications Associated With Lymphadenectomy (LAD) in Surgical Treatment of Non-small Cell Lung Cancer (NSCLC).
A study testing Systematic mediastinal nodal dissection (SND) and Lobe-Specific Lymph Node Dissection (L-SND) in people with Lymph Node Dissection and Advanced Non-small Cell Lung Cancer (NSCLC), run by Regional Clinical Oncology Dispensary at 1 site in Russia.
Trial summary
Systemic mediastinal lymph node dissection is a standard step in radical surgery for advanced non-small cell lung cancer (NSCLC). However, it does not carry the risks associated with certain procedures (chylothorax, recurrent nerve palsy, diaphragmatic relaxation, intrapleural hemorrhage, injury to other chest organs… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymph Node Dissection, Advanced Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- Systematic mediastinal nodal dissection (SND) and Lobe-Specific Lymph Node Dissection (L-SND)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteRussia
- Study dates
- 14 Aug 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥18 years.
- Clinical stage IA-IIIB NSCLC (TNM 8th edition), oncologically radical resection is planned: anatomical segmentectomy/lobectomy/bilobectomy/pneumonectomy (including sleeve resection).
- LND (systematic) is performed with mandatory inclusion of group 7 (subcarinal) lymph nodes.
- Signed informed consent from all study patients.
Who cannot join
- Small cell lung cancer, benign and metastatic tumors.
- "Wedge" surgery without any lymph node dissection.
- Nonemergency surgery; conversion is acceptable.
- Patients who cannot complete 30 days of observation (no contact, etc.) should be excluded prior to surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter Prospective Observational Study of the Incidence and Predictors of Complications Directly Related to Lymphadenectomy (LAD) in Surgical Treatment of Non-small Cell Lung Cancer (NSCLC).
Systemic mediastinal lymph node dissection is a standard step in radical surgery for advanced non-small cell lung cancer (NSCLC). However, it does not carry the risks associated with certain procedures (chylothorax, recurrent nerve palsy, diaphragmatic relaxation, intrapleural hemorrhage, injury to other chest organs (esophagus, great vessels), etc.). Data on their incidence and predictors in routine practice are limited.
Objective: To assess trends and characteristics of projects directly related to Lymph Node Dissection and to identify independent risk factors for their development.
Read the detailed description
Non-small cell lung cancer remains one of the leading causes of cancer-related mortality. Surgical treatment in resectable stages is considered the main radical modality, and systematic mediastinal lymph node dissection is an integral part of this approach. Mediastinal Lymph Node Dissection (MLND) ensures accurate pathomorphological staging, enables detection of subclinical lymph node involvement and improves the quality of locoregional control. At the same time, extending the volume of lymph node dissection increases the invasiveness of the procedure and may lead to serious specific complications.
In routine clinical practice, data on the incidence of these complications and on the risk factors for their development are limited and fragmented, which makes it difficult to assess the risk-benefit ratio when choosing the extent of lymph node dissection for an individual patient.
Published data on the incidence of complications after mediastinal lymph node dissection are highly variable, which is related to differences in study design, complication recording criteria, extent of lymph node dissection and surgeon experience. In addition, most reports are based on data from highly specialized centers and do not fully reflect routine clinical practice. The limited and heterogeneous nature of the available information hinders the development of clear recommendations for risk stratification.
It is assumed that the likelihood of complications is influenced by both surgical factors (extent and anatomical field of lymph node dissection, surgical approach - thoracotomy vs. video-assisted thoracoscopic surgery, duration of the operation, intraoperative blood loss) and patient-related characteristics (age, comorbidities, functional status, tumor location and stage). However, the independent contribution of each of these factors has not been fully defined.
The aim of the present study is to systematize data on the real-world incidence and pattern of complications directly related to Mediastinal Lymph Node Dissection in routine practice and, using multivariable analysis, to identify independent predictors of their development. Evaluating these parameters will make it possible to:
refine the safety profile of mediastinal lymph node dissection;
identify patient groups at increased risk of complications;
optimize the strategy of surgical treatment for advanced non-small cell lung cancer (NSCLC), including the choice of the extent of lymph node dissection and postoperative monitoring.
The findings may serve as a basis for improving clinical guidelines and for a more personalized approach to planning radical procedures in patients with advanced non-small cell lung cancer.
- Being tested
- Systematic mediastinal nodal dissection (SND), Lobe-Specific Lymph Node Dissection (L-SND)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic mediastinal nodal dissection (SND)Procedure or surgery
removal of all tissue with lymph nodes in the relevant areas with a minimum of: ≥3 mediastinal stations always including group 7 lymph nodes.
Lobe-Specific Lymph Node Dissection (L-SND)Procedure or surgery
removal of all tissue with lymph nodes in the relevant areas with a minimum of: ≥3 mediastinal stations always including group 7 lymph nodes.
| Study group | Role | What they receive |
|---|---|---|
| Surgical intervention | Experimental | * Surgical approach: open/VATS.
* Recorded characteristics: 4L-station dissection (yes/no), recurrent nerve visualization, use of energy devices (specify which: bipolar coagulation, ultrasound, or monopolar energy) on the 4L-station, prophylactic duct clipping (yes/no), number of drains/aspiration mode. Receives: Procedure: Systematic mediastinal nodal dissection (SND); Procedure: Lobe-Specific Lymph Node Dissection (L-SND) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and outcome after Lymphadenectomy complications within 30 days after surgery
Frequency and outcome after Lymphadenectomy complications within 30 days after surgery (including in-hospital and rehospitalizations): TM\&M ≥IIIa.
Measured: 30 days
Secondary outcomes (1)
The frequency of each of the initially obtained complications separately.
Any Lymphadenectomy complications (TM\&M I-V), severity profile.
- Postoperative persistent cough associated with LAE: new or significantly worsened compared to preoperative level; assessment by Visual Analog Scale (VAS) (0-10) and Leicester Cough Questionnaire (LCQ) questionnaire; duration and need for conservative therapy are recorded (initial postoperative assessment at discharge, day 30, day 90).
Definition of clinically significant cough: ΔVAS ≥2 points or a decrease in the total LCQ score ≥1 point on day 30, after excluding alternative causes (pneumonia, atelectasis, COPD exacerbation, heart failure).
- Reoperations and invasive interventions for lymphadenectomy complications.
- Duration of drainage, total hospital stay (days), ICU stay (hours)
- 30- and 90-day mortality; 30- and 90-day readmission.
- Voice/dysphagia (Voice Handicap Index questionnaire (short form), if this complication is present), need for medial thyroplasty/injection laryngoplasty at 90 days.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start14 Aug 2025
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymph Node DissectionStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regional Clinical Oncology Dispensary
- Sponsor type
- Other government
- Collaborators
- National Medical Research Center of Phthisiopulmonology and Infectious Diseases, National Medical Research Radiological Centre of the Ministry of Health of Russia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401498
- Sponsor's protocol ID
- 6140825
- Acronym
- LNDNSCLC-RUS
- Status last verified
- Feb 2026
- First submitted
- 1 Dec 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Observational Study of the Incidence and Predictors of Complications Directly Related to Lymphadenectomy (LAD) in Surgical Treatment of Non-small Cell Lung Cancer (NSCLC).
- ClinicalTrials.gov ID
- NCT07401498
- Acronym / sponsor ID
- LNDNSCLC-RUS / 6140825
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Regional Clinical Oncology DispensaryOther government
- Collaborators
- National Medical Research Center of Phthisiopulmonology and Infectious Diseases, National Medical Research Radiological Centre of the Ministry of Health of Russia
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 10 Feb 2026 (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.
Systemic mediastinal lymph node dissection is a standard step in radical surgery for advanced non-small cell lung cancer (NSCLC). However, it does not carry the risks associated with certain procedures (chylothorax, recurrent nerve palsy, diaphragmatic relaxation, intrapleural hemorrhage, injury to other chest organs (esophagus, great vessels), etc.). Data on their incidence and predictors in routine practice are limited.
Objective: To assess trends and characteristics of projects directly related to Lymph Node Dissection and to identify independent risk factors for their development.
Detailed description
Non-small cell lung cancer remains one of the leading causes of cancer-related mortality. Surgical treatment in resectable stages is considered the main radical modality, and systematic mediastinal lymph node dissection is an integral part of this approach. Mediastinal Lymph Node Dissection (MLND) ensures accurate pathomorphological staging, enables detection of subclinical lymph node involvement and improves the quality of locoregional control. At the same time, extending the volume of lymph node dissection increases the invasiveness of the procedure and may lead to serious specific complications.
In routine clinical practice, data on the incidence of these complications and on the risk factors for their development are limited and fragmented, which makes it difficult to assess the risk-benefit ratio when choosing the extent of lymph node dissection for an individual patient.
Published data on the incidence of complications after mediastinal lymph node dissection are highly variable, which is related to differences in study design, complication recording criteria, extent of lymph node dissection and surgeon experience. In addition, most reports are based on data from highly specialized centers and do not fully reflect routine clinical practice. The limited and heterogeneous nature of the available information hinders the development of clear recommendations for risk stratification.
It is assumed that the likelihood of complications is influenced by both surgical factors (extent and anatomical field of lymph node dissection, surgical approach - thoracotomy vs. video-assisted thoracoscopic surgery, duration of the operation, intraoperative blood loss) and patient-related characteristics (age, comorbidities, functional status, tumor location and stage). However, the independent contribution of each of these factors has not been fully defined.
The aim of the present study is to systematize data on the real-world incidence and pattern of complications directly related to Mediastinal Lymph Node Dissection in routine practice and, using multivariable analysis, to identify independent predictors of their development. Evaluating these parameters will make it possible to:
refine the safety profile of mediastinal lymph node dissection;
identify patient groups at increased risk of complications;
optimize the strategy of surgical treatment for advanced non-small cell lung cancer (NSCLC), including the choice of the extent of lymph node dissection and postoperative monitoring.
The findings may serve as a basis for improving clinical guidelines and for a more personalized approach to planning radical procedures in patients with advanced non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical intervention | Experimental | Procedure: Systematic mediastinal nodal dissection (SND), Procedure: Lobe-Specific Lymph Node Dissection (L-SND)* Surgical approach: open/VATS. * Recorded characteristics: 4L-station dissection (yes/no), recurrent nerve visualization, use of energy devices (specify which: bipolar coagulation, ultrasound, or monopolar energy) on the 4L-station, prophylactic duct clipping (yes/no), number of drains/aspiration mode. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years.
- Clinical stage IA-IIIB NSCLC (TNM 8th edition), oncologically radical resection is planned: anatomical segmentectomy/lobectomy/bilobectomy/pneumonectomy (including sleeve resection).
- LND (systematic) is performed with mandatory inclusion of group 7 (subcarinal) lymph nodes.
- Signed informed consent from all study patients.
Key exclusion criteria (4 listed)
- Small cell lung cancer, benign and metastatic tumors.
- "Wedge" surgery without any lymph node dissection.
- Nonemergency surgery; conversion is acceptable.
- Patients who cannot complete 30 days of observation (no contact, etc.) should be excluded prior to surgery.
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 |
|---|---|---|
| Systematic mediastinal nodal dissection (SND)removal of all tissue with lymph nodes in the relevant areas with a minimum of: ≥3 mediastinal stations always including group 7 lymph nodes. | Procedure or surgery | Surgical intervention |
| Lobe-Specific Lymph Node Dissection (L-SND)removal of all tissue with lymph nodes in the relevant areas with a minimum of: ≥3 mediastinal stations always including group 7 lymph nodes. | Procedure or surgery | Surgical intervention |
Primary outcome
Frequency and outcome after Lymphadenectomy complications within 30 days after surgery
Time frame: 30 days
Frequency and outcome after Lymphadenectomy complications within 30 days after surgery (including in-hospital and rehospitalizations): TM\&M ≥IIIa.
1 secondary outcome
The frequency of each of the initially obtained complications separately.
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systematic mediastinal nodal dissection (SND) and Lobe-Specific Lymph Node Dissection (L-SND) in people with Lymph Node Dissection and Advanced Non-small Cell Lung Cancer (NSCLC), run by Regional Clinical Oncology Dispensary at 1 site in Russia.
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 4 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: enrolling by invitation, as of the sponsor's last update on 10 Feb 2026. 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 Russia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and outcome after Lymphadenectomy complications within 30 days after surgery (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2026.