Skip to main content
Clinical Trials/NCT01329575
NCT01329575CompletedNot Applicable

Predicting Malignancy Using Endoluminal Ultrasound Characteristics in Mediastinal Lymph Nodes

Centre hospitalier de l'Université de Montréal (CHUM)1 site in 1 country184 target enrollmentStarted: January 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
184
Locations
1
Primary Endpoint
With a combination of endoluminal ultrasound characteristics, a simple scoring system can be established to help predict malignancy in mediastinal lymph nodes.

Study Overview

Brief Summary

There is no single method to investigate mediastinal LN invasion. Hence, a patient may have to undergo several tests and procedures. Noninvasive and invasive approaches are employed. Within the invasive techniques, endoscopic ultrasonography with needle aspiration (EUS-FNA) and endobronchial ultrasonography with transbronchial needle aspiration (EBUS-TBNA) are gaining importance in mediastinal staging.5 They provide ultrasonographic images and permit needle aspiration under direct vision for cytology specimen analysis. As more evidence is being accumulated on these staging approaches, the number of cervical mediastinoscopies, considered as the gold-standard for mediastinal staging, is diminishing.

Color Doppler LN characteristics with endoluminal ultrasound (US) is only mentioned in a small number of studies and needs to be further investigated.13,14 With the good results obtained with superficial US, it seems reasonable to believe that color Doppler characteristics would increase accuracy in detecting malignancy of mediastinal LNs with endoluminal US.

Detailed Description

Lung cancer is the leading cause of cancer-related death in the United States with a 5-year survival rate of 15,7%.1 In lung cancer and other malignancies, such as esophageal cancer, accurate staging is essential to establish prognosis and for patient management. Staging will help determine if surgery, chemotherapy, radiation therapy, a combination of these, or a palliative approach is the most adequate.2,3

Assessment of lymph nodes (LNs) for invasion by metastasis is undertaken if patient management is influenced by a positive or negative result. In non-small cell lung cancer (NSCLC), mediastinal LN invasion by malignant cells is a critical factor to determine if a patient is considered as a surgical candidate or not.2 In esophageal cancer, LN metastasis may be found in the mediastinum, the neck and the abdomen.4 Invasion of these LNs must be considered in the selection of treatment of esophageal cancer.3,4

There is no single method to investigate mediastinal LN invasion. Hence, a patient may have to undergo several tests and procedures. Noninvasive and invasive approaches are employed. Within the invasive techniques, endoscopic ultrasonography with needle aspiration (EUS-FNA) and endobronchial ultrasonography with transbronchial needle aspiration (EBUS-TBNA) are gaining importance in mediastinal staging.5 They provide ultrasonographic images and permit needle aspiration under direct vision for cytology specimen analysis. As more evidence is being accumulated on these staging approaches, the number of cervical mediastinoscopies, considered as the gold-standard for mediastinal staging, is diminishing.6

Characteristics of benign and malignant LNs using ultrasonography have been described in various contexts. Cervical and axillary LNs provided accurate characteristics (eg. shape, short- to long-axis ratio, number of blood vessels in LN, vascularization pattern, etc.) in predicting malignancy with linear superficial transducers.7-11 LN characteristics using EUS or EBUS also have established criteria predicting mediastinal LN malignancy (eg. size, shape, borders and echogenicity).12 Depending on the studies, it has been suggested to obtain specimens of all accessible LNs without considering their characteristics. It has also been suggested to proceed to a selective LN aspiration based on LN characteristics, with the advantage of cost reduction (fewer needles used, less time to carry out procedure, and specimens needed to be analysed).6

Color Doppler LN characteristics with endoluminal ultrasound (US) is only mentioned in a small number of studies and needs to be further investigated.13,14 With the good results obtained with superficial US, it seems reasonable to believe that color Doppler characteristics would increase accuracy in detecting malignancy of mediastinal LNs with endoluminal US.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients undergoing EUS-FNA and/or EBUS-TBNA for mediastinal LN assessment

Exclusion Criteria

  • Age < 18 years old
  • Inability to consent to the study
  • Medications including Warfarin (Coumadin) or Clopidogrel (Plavix)
  • Coagulopathy

Outcomes

Primary Outcomes

With a combination of endoluminal ultrasound characteristics, a simple scoring system can be established to help predict malignancy in mediastinal lymph nodes.

Time Frame: 3 months

collected characteristics univariate and multivariate logistic regressions will be used to establish a scoring system to predict malignancy. Sensitivity, specificity, positive predictive value, negative predictive value and accuracy will be determined based on the developed model.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Predicting Malignancy Using Endoluminal... | Clinical Trial