Clinical trial · Interventional

Significance of Ultrasound Elastography in Lymph Node

Significance of Endoscopic Ultrasonography Guided Transbronchial Lymph Node Biopsy (TBNA) and Ultrasound Elastography in Lymph Node

NCT03391557CI-TRIAL-00031375unknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Background and Objectives: Elastography can reflect the difference of tissue hardness, which helps to identify the difference of hardness between benign and malignant tissues. The aim of this study was to evaluate the value of endobronchial ultrasound elastography in the differential diagnosis of benign and malignant intrathoracic lymph nodes. Materials and Methods: A total of 42 patients with intrathoracic lymphadenopathy required for EBUS-TBNA examination were prospectively enrolled. Firstly, All patients were evaluated by enhanced chest CT examination,the EBUS B-mode ultrasound and EBUS-guided elastography before EBUS-TBNA.Then, the investigators evaluated every lymph node by describing the characteristics of the CT image (Short diameter, texture, shape, boundary ,mean CT value), B-mode ultrasound (short diameter, echo characteristic, shape, boundary) and elastography (image type, grading score, strain rate, blue area ratio). Finally, the pathological results were used as the gold standard. the investigators compare the characteristics of the 3 evaluating methods alone and in combination between benign and malignant lymph nodes.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Lung Cancer	Malignant Lung Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
UE	Diagnostic Test	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Patients with the UE examination
description
Patients with enlarged intrathoracic lymph nodes(≥1cm) and/or 18-FDG high uptake (SUV Max \> 2.5) without bleeding tendency, abnormal coagulation function and serious cardiac dysfunction were finally selected.
interventionNames
1. Diagnostic Test: UE

Primary outcomes (1)

measure
The echo characteristic of the B-mode ultrasound of lymph nodes.
timeFrame
10 minutes
description
echo characteristic(hypoechoic or not hypoechoic, homogeneous or not)

Secondary outcomes (7)

measure
The shape of the B-mode ultrasound of lymph nodes.
timeFrame

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 27 Years
Maximum age: 81 Years

Show eligibility criteria text

Inclusion Criteria:

1. Patients who have enlarged intrathoracic lymph nodes(≥1cm) evaluated by chest enhanced CT and/or 18-FDG high uptake (SUV Max \> 2.5) evaluated by 18-FDG PET-CT.
2. Patients who are willing to undergo electronic bronchoscopy and agreed to take TBNA and EBUS-TBNA for pathology.

Exclusion Criteria:

1. There is a contraindication of electronic bronchoscopy: activity of hemoptysis, hypertension and arrhythmia, recent myocardial infarction or unstable angina pectoris attacks, serious heart and lung dysfunction, bleeding tendency which cannot be corrected, serious obstruction of superior vena cava syndrome, suspected aortic aneurysm, multiple pulmonary bullous,the body condition is extremely exhaustion, the pregnant or lactation period women, the infected wound deferred, uncontrollable mental illness.
2. Patients who are not willing to accept electronic bronchoscopy.

References

Publications (12)

BACKGROUNDOphir J, Cespedes I, Ponnekanti H, Yazdi Y, Li X. Elastography: a quantitative method for imaging the elasticity of biological tissues. Ultrason Imaging. 1991 Apr;13(2):111-34. doi: 10.1177/016173469101300201. PMID 1858217
BACKGROUNDSaftoiu A, Vilman P. Endoscopic ultrasound elastography-- a new imaging technique for the visualization of tissue elasticity distribution. J Gastrointestin Liver Dis. 2006 Jun;15(2):161-5. PMID 16802011
BACKGROUNDDietrich CF, Jenssen C, Herth FJ. Endobronchial ultrasound elastography. Endosc Ultrasound. 2016 Jul-Aug;5(4):233-8. doi: 10.4103/2303-9027.187866. PMID 27503154
BACKGROUNDDietrich CF, Saftoiu A, Jenssen C. Real time elastography endoscopic ultrasound (RTE-EUS), a comprehensive review. Eur J Radiol. 2014 Mar;83(3):405-14. doi: 10.1016/j.ejrad.2013.03.023. Epub 2013 May 1. PMID 23643030
BACKGROUNDZhou BG, Wang D, Ren WW, Li XL, He YP, Liu BJ, Wang Q, Chen SG, Alizad A, Xu HX. Value of shear wave arrival time contour display in shear wave elastography for breast masses diagnosis. Sci Rep. 2017 Aug 1;7(1):7036. doi: 10.1038/s41598-017-07389-0. PMID 28765627
BACKGROUNDZhang F, Zhao X, Han R, Du M, Li P, Ji X. Comparison of Acoustic Radiation Force Impulse Imaging and Strain Elastography in Differentiating Malignant From Benign Thyroid Nodules. J Ultrasound Med. 2017 Dec;36(12):2533-2543. doi: 10.1002/jum.14302. Epub 2017 Jun 24. PMID 28646602
BACKGROUNDWoo S, Suh CH, Kim SY, Cho JY, Kim SH. Shear-Wave Elastography for Detection of Prostate Cancer: A Systematic Review and Diagnostic Meta-Analysis. AJR Am J Roentgenol. 2017 Oct;209(4):806-814. doi: 10.2214/AJR.17.18056. Epub 2017 Aug 10. PMID 28796546
Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5.