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临床试验/NCT07401498
NCT07401498Enrolling By Invitation不适用

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).

Regional Clinical Oncology Dispensary1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年8月14日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
1,000
试验地点
1
主要终点
Frequency and outcome after Lymphadenectomy complications within 30 days after surgery

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Systematic mediastinal nodal dissection (SND) (Procedure)

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.

干预措施: Lobe-Specific Lymph Node Dissection (L-SND) (Procedure)

结局指标

主要结局

Frequency and outcome after Lymphadenectomy complications within 30 days after surgery

时间窗: 30 days

Frequency and outcome after Lymphadenectomy complications within 30 days after surgery (including in-hospital and rehospitalizations): TM\&M ≥IIIa.

次要结局

  • The frequency of each of the initially obtained complications separately.(90 days)

研究者

发起方
Regional Clinical Oncology Dispensary
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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