MediastinumNCT02724059
The Role of Endobronchial Ultrasound Elastography in the Diagnosis of Mediastinal Lesions
A study testing EBUS with elastography followed by TBNA in people with Mediastinum, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mediastinum
- What is being tested?
- EBUS with elastography followed by TBNA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Chest Department, Faculty of Medicine, Tanta University
Tanta, Gharbia Governorate, 31111
About this study
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.
Read the detailed description
All patients will be subjected to the following parameters:
- Thorough history taking and full clinical examination.
- Chest X-ray (postro-anterior and lateral views) before and after the procedure.
- Recent Computed Tomography (CT chest) with contrast.
- Laboratory studies:
- Complete liver functions.
- Blood urea and serum creatinine.
- Complete blood picture (including platelet count).
- Erythrocyte sedimentation rate (ESR).
- Fasting and postprandial blood sugar.
- Preoperative evaluation: Pulmonary function tests (PFT), Electrocardiogram (ECG), arterial blood gases (ABG) and coagulation profile (including bleeding \& clotting times, prothrombin time\& activity and activated partial thromboplastin time (APTT)) and oral anticoagulants should be stopped before the procedure for at least 48 hours.
- Color doppler ultrasound in suspected vascular lesions.
- Clinical and radiological follow up of patients over 1 week after the procedure to detect the occurrence of any complications.
- The biopsy samples will be examined histopathologically. EBUS-guided TBNA examinations will be performed in all cases at the pulmonary department of Tanta University Educational Hospital as an outpatient procedure in a dedicated bronchoscopy suit with Pantex EBUS probe and Hitachi ultrasound a 7.5 MHz, BF-UC160F (Olympus Optical Co., Tokyo, Japan, approved by FDA) convex probe bronchoscope and EU C2000 processor (Olympus, Tokyo, Japan) by oral route and in the supine position under local anesthesia with lidocaine and conscious sedation with intravenous midazolam.
Lymph nodes will be identified according to the Mountain's regional lymph node classification system (5). The lymph node stations of 2, 4, 7, 10 and 11 will be evaluated systematically. After the appearance of target lymph nodes, the diameter, shape, edge definition, internal echo distribution, and location of the lymph nodes will be recorded in conventional B mode by ultrasound.
Elastography will be performed on all lymph nodes that will be candidates for EBUS TBNA. The scan range will include the entire lymph node and the surrounding normal tissue. Elastographic and B mode images will be simultaneously displayed side by side on the monitor. Elastographic patterns will be described according to the dominant colors and their distribution within the target lymph node. The strain ratio can be only measured when good contact and appropriate compression of the transducer will be achieved, as indicated by the elastography image on the ultrasound processor. The largest possible area of the node will be outlined from the superimposed elastography image; the same procedure will be performed on a similar-sized area that is surrounded by apparently normal tissue. The ultrasound processor measured the strain of each area as a quantitative figure, and the strain ratio between the two areas will be calculated. The strain ratio will be recorded a minimum of 3 times prior to EBUS-TBNA. The means of these recordings will also be calculated. (4) After elastography, EBUS TBNA will be performed with a Cook 22 gauge needle (c976006, Cook Ireland Limited Liability Company, Ireland). The number of passes per patient will be recorded. N3 nodes will be sampled first and then N2 nodes to avoid contamination in lung cancer patients. Histological and cytological specimens will be collected and sent to the laboratory for subsequent analysis by pathologist who will be blinded to the elastography values.
Aspiration specimen will be considered "insufficient" if there will not be an adequate number of lymphocytes on the smear. A definitive diagnosis of malignancy from the EBUS TBNA specimens will be considered a positive result. No clear evidence of malignancy or inadequate specimen by EBUS TBNA will be deemed a negative result.
For the patients whose results are negative for malignancy, more invasive procedures such as mediastinoscopy will be done to confirm the diagnosis or radiologic follow-up on the outcome of the LNs for at least 6 months. On follow-up, LNs that persisted in size, diminished, or resolved will be considered benign. A diagnosis of tuberculosis or sarcoidosis will be made based on cytopathology that showed the presence of caseating or noncaseating granuloma, in addition to clinical, radiological, and microbiological findings.
- Conditions
- Mediastinum
- Being tested
- EBUS with elastography followed by TBNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBUS with elastography followed by TBNAProcedure or surgery
Endo bronchial ultrasound (EBUS) with elastography followed by TBNA from mediastinal lesions or lymph nodes
| Study group | Role | What they receive |
|---|---|---|
| Patients with mediastinal lesions | Experimental | Endo bronchial ultrasound (EBUS) with elastography followed by TBNA Receives: Procedure: EBUS with elastography followed by TBNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with correct diagnosis of mediastinal lesions (benign or malignant) using elastography
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startNov 2015
- Primary completionApr 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MediastinumStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adel Salah Bediwy, Tanta University
- Investigators
- Adel S Bediwy, MD, Study chair, Chest Department, Faculty of Medicine, Tanta UniversityMohamed S Hantera, MD, Principal investigator, Chest Department, Faculty of Medicine, Tanta UniversityAyman El-Saqa, MD, Principal investigator, Pathology Department, Faculty of Medicine, Tanta UniversityDalia ElSharawy, MD, Principal investigator, Chest Department, Faculty of Medicine, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724059
- Sponsor's protocol ID
- TFMEC221015
- Status last verified
- Apr 2018
- First submitted
- 19 Mar 2016
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 26807274
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Endobronchial Ultrasound Elastography in the Diagnosis of Mediastinal Lesions
- ClinicalTrials.gov ID
- NCT02724059
- Acronym / sponsor ID
- TFMEC221015
- Conditions
- Mediastinum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 31 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
All patients will be subjected to the following parameters:
- Thorough history taking and full clinical examination.
- Chest X-ray (postro-anterior and lateral views) before and after the procedure.
- Recent Computed Tomography (CT chest) with contrast.
- Laboratory studies:
- Complete liver functions.
- Blood urea and serum creatinine.
- Complete blood picture (including platelet count).
- Erythrocyte sedimentation rate (ESR).
- Fasting and postprandial blood sugar.
- Preoperative evaluation: Pulmonary function tests (PFT), Electrocardiogram (ECG), arterial blood gases (ABG) and coagulation profile (including bleeding \& clotting times, prothrombin time\& activity and activated partial thromboplastin time (APTT)) and oral anticoagulants should be stopped before the procedure for at least 48 hours.
- Color doppler ultrasound in suspected vascular lesions.
- Clinical and radiological follow up of patients over 1 week after the procedure to detect the occurrence of any complications.
- The biopsy samples will be examined histopathologically. EBUS-guided TBNA examinations will be performed in all cases at the pulmonary department of Tanta University Educational Hospital as an outpatient procedure in a dedicated bronchoscopy suit with Pantex EBUS probe and Hitachi ultrasound a 7.5 MHz, BF-UC160F (Olympus Optical Co., Tokyo, Japan, approved by FDA) convex probe bronchoscope and EU C2000 processor (Olympus, Tokyo, Japan) by oral route and in the supine position under local anesthesia with lidocaine and conscious sedation with intravenous midazolam.
Lymph nodes will be identified according to the Mountain's regional lymph node classification system (5). The lymph node stations of 2, 4, 7, 10 and 11 will be evaluated systematically. After the appearance of target lymph nodes, the diameter, shape, edge definition, internal echo distribution, and location of the lymph nodes will be recorded in conventional B mode by ultrasound.
Elastography will be performed on all lymph nodes that will be candidates for EBUS TBNA. The scan range will include the entire lymph node and the surrounding normal tissue. Elastographic and B mode images will be simultaneously displayed side by side on the monitor. Elastographic patterns will be described according to the dominant colors and their distribution within the target lymph node. The strain ratio can be only measured when good contact and appropriate compression of the transducer will be achieved, as indicated by the elastography image on the ultrasound processor. The largest possible area of the node will be outlined from the superimposed elastography image; the same procedure will be performed on a similar-sized area that is surrounded by apparently normal tissue. The ultrasound processor measured the strain of each area as a quantitative figure, and the strain ratio between the two areas will be calculated. The strain ratio will be recorded a minimum of 3 times prior to EBUS-TBNA. The means of these recordings will also be calculated. (4) After elastography, EBUS TBNA will be performed with a Cook 22 gauge needle (c976006, Cook Ireland Limited Liability Company, Ireland). The number of passes per patient will be recorded. N3 nodes will be sampled first and then N2 nodes to avoid contamination in lung cancer patients. Histological and cytological specimens will be collected and sent to the laboratory for subsequent analysis by pathologist who will be blinded to the elastography values.
Aspiration specimen will be considered "insufficient" if there will not be an adequate number of lymphocytes on the smear. A definitive diagnosis of malignancy from the EBUS TBNA specimens will be considered a positive result. No clear evidence of malignancy or inadequate specimen by EBUS TBNA will be deemed a negative result.
For the patients whose results are negative for malignancy, more invasive procedures such as mediastinoscopy will be done to confirm the diagnosis or radiologic follow-up on the outcome of the LNs for at least 6 months. On follow-up, LNs that persisted in size, diminished, or resolved will be considered benign. A diagnosis of tuberculosis or sarcoidosis will be made based on cytopathology that showed the presence of caseating or noncaseating granuloma, in addition to clinical, radiological, and microbiological findings.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with mediastinal lesions | Experimental | Procedure: EBUS with elastography followed by TBNAEndo bronchial ultrasound (EBUS) with elastography followed by TBNA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EBUS with elastography followed by TBNAEndo bronchial ultrasound (EBUS) with elastography followed by TBNA from mediastinal lesions or lymph nodes | Procedure or surgery | Patients with mediastinal lesions |
Primary outcome
Number of participants with correct diagnosis of mediastinal lesions (benign or malignant) using elastography
Time frame: 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2018.
- Results publication: PubMed 26807274Jiang 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.
- Individual participant dataSharing planned: Undecided
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Recruiting
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Mediastinum Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adel S Bediwy, MD study chair
Chest Department, Faculty of Medicine, Tanta University
Mohamed S Hantera, MD principal investigator
Chest Department, Faculty of Medicine, Tanta University
Ayman El-Saqa, MD principal investigator
Pathology Department, Faculty of Medicine, Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EBUS with elastography followed by TBNA in people with Mediastinum, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with correct diagnosis of mediastinal lesions (benign or malignant) using elastography (time frame: 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02724059, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2018.