NCT02690610

Brief Summary

This prospective 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 ROSE during EBUS-guided TBNA. Mediastinoscopy or other invasive procedures will be performed if EBUS-guided TBNA doesn't provide representative material.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

April 25, 2018

Status Verified

April 1, 2018

Enrollment Period

6 months

First QC Date

January 30, 2016

Last Update Submit

April 23, 2018

Conditions

Mediastinum

Keywords

EBUS, Mediastinal lesions, Mediastinal lymph node

Outcome Measures

Primary Outcomes (1)

  • Number of participants with accurate diagnosis of mediastinal lesions in relation to the total number studied.

    4-6 months

Study Arms (1)

Patients with mediastinal lesions

EXPERIMENTAL

EBUS TBNA of mediastinal lesions or lymph nodes

Procedure: EBUS TBNA of mediastinal lesions or lymph nodes

Interventions

EBUS TBNA of mediastinal lesions or lymph nodesPROCEDURE

Through endo-bronchial ultrasound, a transbronchial needle will be introduced to take biopsies from mediastinal lesions under ultrasonic guidance.

Patients with mediastinal lesions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 lung cancer when there is no endobronchial lesion.
  • Diagnosis of both benign (especially tuberculosis and sarcoidosis) and malignant mediastinal lesions (eg. thymoma).

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).
  • Respiratory failure and patient on mechanical ventilation.
  • Severe chronic obstructive pulmonary disease (COPD) (FEV1\<1 liter or \<35% predicted).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chest Department, Faculty of Medicine, Tanta University

Tanta, Gharbia Governorate, 31111, Egypt

Location

Related Publications (4)

  • Herth FJ, Rabe KF, Gasparini S, Annema JT. Transbronchial and transoesophageal (ultrasound-guided) needle aspirations for the analysis of mediastinal lesions. Eur Respir J. 2006 Dec;28(6):1264-75. doi: 10.1183/09031936.00013806.

    PMID: 17138681RESULT

  • Herth FJ, Krasnik M, Kahn N, Eberhardt R, Ernst A. Combined endoscopic-endobronchial ultrasound-guided fine-needle aspiration of mediastinal lymph nodes through a single bronchoscope in 150 patients with suspected lung cancer. Chest. 2010 Oct;138(4):790-4. doi: 10.1378/chest.09-2149. Epub 2010 Feb 12.

    PMID: 20154073RESULT

  • Geake J, Hammerschlag G, Nguyen P, Wallbridge P, Jenkin GA, Korman TM, Jennings B, Johnson DF, Irving LB, Farmer M, Steinfort DP. Utility of EBUS-TBNA for diagnosis of mediastinal tuberculous lymphadenitis: a multicentre Australian experience. J Thorac Dis. 2015 Mar;7(3):439-48. doi: 10.3978/j.issn.2072-1439.2015.01.33.

    PMID: 25922723RESULT

  • Cardoso AV, Neves I, Magalhaes A, Sucena M, Barroca H, Fernandes G. The value of rapid on-site evaluation during EBUS-TBNA. Rev Port Pneumol (2006). 2015 Sep-Oct;21(5):253-8. doi: 10.1016/j.rppnen.2015.02.003. Epub 2015 Apr 1.

    PMID: 25926258RESULT

Study Officials

  • Adel Salah Bediwy, MD

    Chest Department, Faculty of Medicine, Tanta University

    STUDY CHAIR

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

January 30, 2016

First Posted

February 24, 2016

Study Start

November 1, 2015

Primary Completion

May 1, 2016

Study Completion

September 1, 2016

Last Updated

April 25, 2018

Record last verified: 2018-04

Locations

EG(1)