MediastinumNCT02690610
Value of Rapid on Site Evaluation During EBUS-guided TBNA in the Diagnosis of Mediastinal Lesions
A study testing EBUS TBNA of mediastinal lesions or lymph nodes in people with Mediastinum, run by Tanta University at 1 site in Egypt.
Trial 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. 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 TBNA of mediastinal lesions or lymph nodes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2015to Sep 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 lung cancer when there is no endobronchial lesion.
- Diagnosis of both benign (especially tuberculosis and sarcoidosis) and malignant mediastinal lesions (eg. thymoma).
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).
- 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
Official title: Value of Rapid on Site Evaluation During Endobronchial Ultrasound Guided Trans-bronchial Needle Aspiration (EBUS-TBNA) in the Diagnosis of Mediastinal Lesions
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.
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-TBNA will be done within 10 days of CT examination under local anesthesia and conscious sedation.
Convex Probe EBUS- Guided TBNA EBUS-guided TBNA examinations will be performed at both Tanta University Educational Hospital and Kobry Elkoba Military Hospital using Pantex EBUS probe and Hitachi ultrasound in the supine position under local anesthesia with lidocaine and conscious sedation.
Lymph nodes will be identified according to the Mountain's regional lymph node classification system (17). The lymph node stations of 2, 4, 7, 10 and 11 were evaluated systematically. During the process for every detected lymph node; short and long axis diameters, station of the lymph node, number of passes per patient and per lymph node were recorded for each patient.
N3 nodes will be sampled first and then N2 nodes to avoid contamination in lung cancer patients. The materials obtained by EBUS-guided TBNA will be smeared on slides. These slides will be air-dried and Diff-Quik (American Scientific Products, McGaw Park, IL) staining will be used for ROSE. Additional smears will be prepared for Papanicolaou staining and any remaining sample will be placed in 10% formalin for histologic evaluation. The results of ROSE were compared with the results of the final pathologic diagnosis. (17) Aspiration specimen was considered "insufficient" if there were not an adequate number of lymphocytes on the smear. Diagnosis as "malignant" in cytologic examination was considered as the "final diagnosis". For the patients whose EBUS-guided TBNA results were 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 were 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.
Any unexpected risk will be cleared to the participant and to Ethics committee. Waste materials will be disposed properly. All patients will sign an informed written consent. Patients' names will not be used and will be replaced by code numbers to confirm their privacy. Also, the results of the study will be used only for scientific purpose.
- Conditions
- Mediastinum
- Being tested
- EBUS TBNA of mediastinal lesions or lymph nodes
- Keywords
- EBUS, Mediastinal lesions, Mediastinal lymph node
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBUS TBNA of mediastinal lesions or lymph nodesProcedure or surgery
Through endo-bronchial ultrasound, a transbronchial needle will be introduced to take biopsies from mediastinal lesions under ultrasonic guidance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with mediastinal lesions | Experimental | EBUS TBNA of mediastinal lesions or lymph nodes Receives: Procedure: EBUS TBNA of mediastinal lesions or lymph nodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with accurate diagnosis of mediastinal lesions in relation to the total number studied.
Measured: 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startNov 2015
- Primary completionMay 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 67 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 Salah Bediwy, MD, Study chair, Chest Department, Faculty of Medicine, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690610
- Sponsor's protocol ID
- 30613/11/15
- Status last verified
- Apr 2018
- First submitted
- 30 Jan 2016
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 17138681Herth 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.
PubMed 20154073Geake 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.
PubMed 25922723Cardoso 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.
PubMed 25926258
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
- Value of Rapid on Site Evaluation During Endobronchial Ultrasound Guided Trans-bronchial Needle Aspiration (EBUS-TBNA) in the Diagnosis of Mediastinal Lesions
- ClinicalTrials.gov ID
- NCT02690610
- Acronym / sponsor ID
- 30613/11/15
- Conditions
- Mediastinum
- Keywords
- EBUS, Mediastinal lesions, Mediastinal lymph node
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 24 Feb 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.
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.
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-TBNA will be done within 10 days of CT examination under local anesthesia and conscious sedation.
Convex Probe EBUS- Guided TBNA EBUS-guided TBNA examinations will be performed at both Tanta University Educational Hospital and Kobry Elkoba Military Hospital using Pantex EBUS probe and Hitachi ultrasound in the supine position under local anesthesia with lidocaine and conscious sedation.
Lymph nodes will be identified according to the Mountain's regional lymph node classification system (17). The lymph node stations of 2, 4, 7, 10 and 11 were evaluated systematically. During the process for every detected lymph node; short and long axis diameters, station of the lymph node, number of passes per patient and per lymph node were recorded for each patient.
N3 nodes will be sampled first and then N2 nodes to avoid contamination in lung cancer patients. The materials obtained by EBUS-guided TBNA will be smeared on slides. These slides will be air-dried and Diff-Quik (American Scientific Products, McGaw Park, IL) staining will be used for ROSE. Additional smears will be prepared for Papanicolaou staining and any remaining sample will be placed in 10% formalin for histologic evaluation. The results of ROSE were compared with the results of the final pathologic diagnosis. (17) Aspiration specimen was considered "insufficient" if there were not an adequate number of lymphocytes on the smear. Diagnosis as "malignant" in cytologic examination was considered as the "final diagnosis". For the patients whose EBUS-guided TBNA results were 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 were 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.
Any unexpected risk will be cleared to the participant and to Ethics committee. Waste materials will be disposed properly. All patients will sign an informed written consent. Patients' names will not be used and will be replaced by code numbers to confirm their privacy. Also, the results of the study will be used only for scientific purpose.
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 TBNA of mediastinal lesions or lymph nodesEBUS TBNA of mediastinal lesions or lymph nodes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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 lung cancer when there is no endobronchial lesion.
- Diagnosis of both benign (especially tuberculosis and sarcoidosis) and malignant mediastinal lesions (eg. thymoma).
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).
- 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 TBNA of mediastinal lesions or lymph nodesThrough endo-bronchial ultrasound, a transbronchial needle will be introduced to take biopsies from mediastinal lesions under ultrasonic guidance. | Procedure or surgery | Patients with mediastinal lesions |
Primary outcome
Number of participants with accurate diagnosis of mediastinal lesions in relation to the total number studied.
Time frame: 4-6 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 17138681Herth 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.
- Results publication: PubMed 20154073Herth 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.
- Results publication: PubMed 25922723Geake 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.
- Results publication: PubMed 25926258Cardoso 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.
- Individual participant dataSharing planned: Undecided
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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 Salah Bediwy, MD study chair
Chest 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 TBNA of mediastinal lesions or lymph nodes 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 5 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 accurate diagnosis of mediastinal lesions in relation to the total number studied. (time frame: 4-6 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 NCT02690610, which also lists 4 linked publications.
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.