跳至主要内容
临床试验/CTRI/2024/11/076528
CTRI/2024/11/076528尚未招募不适用

COMPARISON OF PET-CT AND ENDOBRONCHIAL ULTRASOUND WITH SURGICAL HISTOPATHOLOGY FOR MEDIASTINAL NODAL STAGING OF NON-SMALL CELL LUNG CANCER IN PATIENTS UNDERGOING SURGERY

AIIMS New Delhi1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2024年11月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
160
试验地点
1
主要终点
To find out the diagnostic accuracies of PET-CT,EBUS compared to surgical histopathology for mediastinal nodal staging of NSCLC. Surgical histopathology will be taken as gold standard.

研究概览

简要总结

Lung cancer is the leading cause of cancer (globally) incidence and mortality, accounting for an estimated 2 million diagnoses and 1.8 million deaths and also leading cause of cancer mortality worldwide.

After initial diagnosis of NSCLC patients undergo for staging with PETCT as the treatment of NSCLC depending on the stage of the disease includes surgical resection with curative intent in early-stage disease and chemoradiation in advanced stage disease. For surgically resect-able cases EBUS is done to stage mediastinum to exclude mediastinal lymph-nodal involvement because for N2 disease there are two options of treatment either definitive chemo-radiation or NACT/NACTRT followed by assessment and surgery for selected patients. For mediastinal staging both the above mentioned tests have its own drawbacks. Studies show when both tests are  used together , a better staging of mediastinum is followed. As EBUS-TBNA may identify additional malignant LNs (7.4%), and this highlights the risk for false-negative findings with PET scanning in isolation. Also there are stations (like station 5/6/8/9) where EBUS cant sample.

The study aims to see the accuracies of PET-CT and EBUS  when they are compared to post-surgical histopathological examination report. Thus this study will provide sensitivity, specificity , positive and negative predictive value of both the tests and how these tests contribute to proper mediastinal staging.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
0.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • All NSCLC lung undergoing surgery after mediastinal nodal evaluation.

排除标准

  • Small cell lung cancer
  • Metastatic NSCLC
  • Dual primary malignancy
  • Recurrent NSCLC
  • Not giving consent for PETCT, EBUS-TBNA, or surgery
  • Received partial treatment outside AIIMS.

结局指标

主要结局

To find out the diagnostic accuracies of PET-CT,EBUS compared to surgical histopathology for mediastinal nodal staging of NSCLC. Surgical histopathology will be taken as gold standard.

时间窗: at time of post op HPE analysis

次要结局

  • To find out and compare the sensitivity, specificity, positive predictive value, and negative predictive value of PET-CT, EBUS . Surgical histopathology will be taken as gold standard(2 years)

研究者

发起方
AIIMS New Delhi
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Shaon Das

AIIMS , New Delhi

研究点 (1)

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