The Role of Endobronchial Ultrasound Elastography in the Diagnosis of Mediastinal Lesions

NCT02724059 | Completed DMC

• 1 other identifier: TFMEC221015
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The study will include 30 patients with hilar/mediastinal lymph nodes detected by thoracic CT either there was a known lung malignancy (for staging purpose) or not (for diagnosing purpose). All patients will undergo to EBUS-guided TBNA. Elastography will be performed on all lymph nodes that will be candidates for EBUS TBNA. Mediastinoscopy or other invasive procedures will be performed if EBUS-guided TBNA doesn't provide representative material.

Conditions

Mediastinum

Outcome Measures

Primary Outcomes (1)

• Number of participants with correct diagnosis of mediastinal lesions (benign or malignant) using elastography

  6 months.

Study Arms (1)

Patients with mediastinal lesions

EXPERIMENTAL

Endo bronchial ultrasound (EBUS) with elastography followed by TBNA

Procedure: EBUS with elastography followed by TBNA

Interventions

EBUS with elastography followed by TBNA PROCEDURE

Endo bronchial ultrasound (EBUS) with elastography followed by TBNA from mediastinal lesions or lymph nodes

Patients with mediastinal lesions

Eligibility Criteria

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

You may qualify if:

• Hilar/mediastinal lymph nodes with a short axis more than 1 cm on thoracic CT scan and/or PET-CT suspicious for malignancy with or without known lung malignancy.
• Hilar and/or mediastinal lymph nodes positive on PET/CT scan without regarding the diameter suspicious for malignancy.
• Recurrence or restaging of NSCLC after chemotherapy or radiation.
• Diagnosis of both benign and malignant mediastinal lesions.

You may not qualify if:

• Cardiovascular instability.
• Lack of patient cooperation, e.g. intractable cough, inability to remain motionless or altered consciousness.
• Bleeding diathesis (activated partial thromboplastin time (APTT) ratio or international normalized ratio (INR) \<1.3 or platelet count of \<50000 per mm3).
• Border line respiratory failure and patient on mechanical ventilation.
• Severe chronic obstructive pulmonary disease (COPD) (FEV1\<1 liter or \<35% predicted).

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Chest Department, Faculty of Medicine, Tanta University

Tanta, Gharbia Governorate, 31111, Egypt

Location

Related Publications (1)

• Jiang JH, Turner JF Jr, Huang JA. Endobronchial ultrasound elastography: a new method in endobronchial ultrasound-guided transbronchial needle aspiration. J Thorac Dis. 2015 Dec;7(Suppl 4):S272-8. doi: 10.3978/j.issn.2072-1439.2015.12.53.

  PMID: 26807274 RESULT

Study Officials

• Adel S Bediwy, MD

  Chest Department, Faculty of Medicine, Tanta University

  STUDY CHAIR

• Mohamed S Hantera, MD

  Chest Department, Faculty of Medicine, Tanta University

  PRINCIPAL INVESTIGATOR

• Ayman El-Saqa, MD

  Pathology Department, Faculty of Medicine, Tanta University

  PRINCIPAL INVESTIGATOR

• Dalia ElSharawy, MD

  Chest Department, Faculty of Medicine, Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 19, 2016
• First Posted: March 31, 2016
• Study Start: November 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: April 25, 2018

Record last verified: 2018-04

Locations

EG (1)