Complications Associated With Lymphadenectomy (LAD) in Surgical Treatment of Non-small Cell Lung Cancer (NSCLC).

NCT07401498 | Enrolling By Invitation

• 1 other identifier: 6140825
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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 (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.

Conditions

Lymph Node Dissection; Advanced Non-small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days

Secondary Outcomes (1)

• The frequency of each of the initially obtained complications separately.

  90 days

Study Arms (1)

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.

Procedure: Systematic mediastinal nodal dissection (SND); Procedure: Lobe-Specific Lymph Node Dissection (L-SND)

Interventions

Systematic mediastinal nodal dissection (SND) PROCEDURE

removal of all tissue with lymph nodes in the relevant areas with a minimum of: ≥3 mediastinal stations always including group 7 lymph nodes.

Surgical intervention

Lobe-Specific Lymph Node Dissection (L-SND) PROCEDURE

removal of all tissue with lymph nodes in the relevant areas with a minimum of: ≥3 mediastinal stations always including group 7 lymph nodes.

Surgical intervention

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years.
• Clinical stage IA-IIIB NSCLC (TNM 8th edition), oncologically radical resection is planned: anatomical segmentectomy/lobectomy/bilobectomy/pneumonectomy (including sleeve resection).
• Signed informed consent from all study patients.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regional Clinical Oncology Dispensary: lead
• National Medical Research Center of Phthisiopulmonology and Infectious Diseases: collaborator
• National Medical Research Radiological Centre of the Ministry of Health of Russia: collaborator

Study Sites (1)

Regional Clinical Oncology Dispensary

Ulyanovsk, Russia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: February 10, 2026
• Study Start: August 14, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

RU (1)