MediastinumTEAMNCT02704078
EBUS-TBNA vs EUS-B-FNA for Needle Aspiration of Mediastinal Lesions
A study testing EBUS-TBNA and EUS-B-FNA in people with Mediastinum, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
Endobronchial Ultrasound Guided Transbronchial Needle aspiration (EBUS-TBNA) is a firmly established modality for diagnostic evaluation of mediastinal lesions. The procedure is routinely performed at the Department of Pulmonary Medicine and Sleep Disorders, AIIMS, New Delhi since 2012. 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 and EUS-B-FNA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2015to Jul 2017
- 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
- Age 18 years and Older
- Predominant Subcarinal or Lower Left paratracheal located mediastinal lymphadenopathy/mediastinal lesions at least >1cm in Short axis diameter.
- Patients who give consent
Who cannot join
- Refusal of consent for the procedure
- Any contraindications to Bronchoscopy / Endobronchial Ultrasound
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Comparison of Trans-tracheal (EBUS-TBNA) Versus Trans-esophageal (EUS-B-FNA) Route as the Primary Approach for Fine Needle Aspiration of Mediastinal Lesions Using the Convex Probe Endobronchial Ultrasound (EBUS) Scope
Endobronchial Ultrasound Guided Transbronchial Needle aspiration (EBUS-TBNA) is a firmly established modality for diagnostic evaluation of mediastinal lesions. The procedure is routinely performed at the Department of Pulmonary Medicine and Sleep Disorders, AIIMS, New Delhi since 2012. Transesophageal approach for fine needle aspiration of mediastinal lesions using the Endobronchial Ultrasound (EBUS) scope [also described as Transesophageal Bronchoscopic Ultrasound Guided Fine Needle aspiration (EUS-B-FNA)] (also routinely performed in the department) and has been described as a safe and efficacious modality. EUS-B-FNA is usually employed when EBUS-TBNA is not feasible or excessive cough or secretions necessitate switch to esophageal route. We hypothesize that EUS-B-FNA as the primary approach has similar diagnostic performance as EBUS-TBNA and is associated with greater patient and operator rated procedure comfort and lesser requirement of anaesthesia medications for evaluation of patients with mediastinal lesions easily accessible with either of the two approaches.
We propose to undertake a prospective randomized comparison of Transesophageal (EUS-B-FNA) versus Transtracheal (EBUS-TBNA) approach for fine needle aspiration using the same EBUS scope in patients referred for endo-sonographic evaluation of mediastinal lesions. A total of 100 serial patients (with Subcarinal and/or Lower Left paratracheal located mediastinal lymphadenopathy at least >1cm in Short axis diameter) shall be included. After consent and preliminary investigations, patients shall be randomized equally into the two approaches. Procedure will be performed under local anaesthesia (topical lignocaine) and i.v. sedation (midazolam and fentanyl) in the bronchoscopy laboratory. The primary objective will be comparison of proportion of diagnostic and adequate aspirates in the two groups. Secondary objectives will include operator rated cough (VAS), Operator rated overall procedure satisfaction (VAS), dose of midazolam and fentanyl administered, lignocaine dose and total procedure duration.The primary data analysis shall be for the performance characteristics of the primary approach. All the aspirates shall be analysed by the same pathologist for final interpretation.
Read the detailed description
Objectives
Primary objective:
Comparison of Proportion of Adequate and Diagnostic Aspirates in the EUS-B-FNA versus EBUS-TBNA arms as the primary approach for mediastinal fine needle aspiration during Convex probe EBUS.
Secondary objectives
- Topical Anaesthetic requirement between the two groups
- Intravenous Sedative / analgesic requirement between the two groups
- Operator rated overall procedure satisfaction (VAS)
- Operator rated cough (VAS)
- Overall duration of procedure Methods Study Design: Prospective randomised study. Sample Size: Number of Patients: 100 (50 -EBUS-TBNA arm, 50- EUS-B-FNA arm)
Inclusion criteria:
- Age 18 years and Older
- Patients with predominant Subcarinal or Lower Left paratracheal located mediastinal lymphadenopathy/mediastinal lesions at least >1cm in Short axis diameter.
- Patients who give consent.
Exclusion criteria:
- Refusal of consent for the procedure
- Any contraindications to Bronchoscopy or Endobronchial Ultrasound procedures
- Pregnancy Controls: None For all patients, a targeted history will be obtained to screen for diabetes mellitus, systemic hypertension, bleeding disorders, cardiac disease, previous anaesthetic complications and any medication history including antiplatelet therapy. Baseline investigations like complete hemogram and prothrombin time will be done, and imaging prior to the procedure will include a chest radiograph and computed tomography (CT) scan of the chest (plain and contrast enhanced).
The patients will then be randomised to 2 groups of 50 patients each. 50 patients in one group will undergo Transtracheal (EBUS-TBNA) approach, whereas in the other group, 50 patients will undergo Transesophageal (EUS-B-FNA) route as the primary approach using the EBUS scope. Procedures will be performed under moderate sedation. Procedures will be performed in the Bronchoscopy Lab.
The size and characteristics of the mediastinal lymph nodes as visualised during EBUS/EUS will be recorded. The concerned mediastinal lymph nodes will be sampled by EBUS-TBNA/EUS-FNA under direct ultrasonic visualisation. The aspirates will be expressed on to slides and will be placed into alcohol cytology bottles. The slides will then be dispatched to the Cytopathology Lab for appropriate stains and further analysis. Lymph node core if obtained will be sent in formalin for Histopathological analysis. Post procedure, the patients will remain in observation for a few hours and will be discharged on the same day. A patient proforma will be completed for each patient separately. The size and stations of the sampled nodes will be recorded. The total duration of procedure, the nature and total dose of anaesthesia or sedation will also be recorded. A Visual-analogue scale (VAS) will be used to assess operator rated procedure related cough and overall operator rated procedure satisfaction.
Statistical Analysis - Descriptive statistics such as mean, median, standard deviation and range will be calculated for all continuous variables. Frequency distributions will be calculated for all qualitative data. Frequency data across categorical variables will be compared using chi-square and fisher's exact test. Among patients with adequate sample on EBUS-TBNA/EUS-B-FNA, sensitivity, specificity, accuracy, and positive and negative predictive values will be calculated using standard formulas. P-value of P<0.05 is considered as statistically significant.
- Conditions
- Mediastinum
- Being tested
- EBUS-TBNA, EUS-B-FNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBUS-TBNADevice
EBUS-TBNA - Patients in the Active comparator arm shall undergo mediastinal lymph node aspiration transtracheally using the EBUS scope
EUS-B-FNADevice
EUS-B-FNA - Patients in the experimental arm EUS-B-FNA shall undergo mediastinal lymph node aspiration transesophageally using the EBUS scope
| Study group | Role | What they receive |
|---|---|---|
| EBUS-TBNA | Active comparator | Mediastinal lymph node aspiration shall be performed transtracheally. Receives: Device: EBUS-TBNA |
| EUS-B-FNA | Experimental | Mediastinal lymph node aspiration shall be performed transesophageally Receives: Device: EUS-B-FNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Sensitivity of EUS-B-FNA versus EBUS-TBNA
The diagnostic yield of EBUS-TBNA shall be compared with EUS-B-FNA ie comparison of the proportion of diagnostic aspirates between the EBUS-TBNA and the EUS-B-FNA groups
Measured: At study completion at approximately 18 months
Secondary outcomes (5)
Topical Anaesthetic requirement between the two groups
Comparison of total lignocaine dose
Measured: Comparing the mean doses of lignocaime administered in mg between the study participants in two groups at study completion at approximately 18 months
Intravenous Sedative / analgesic requirement between the two groups
Comparison of midazolam/fentanyl dose
Measured: Compating the mean doses of sedative administered in mg between the study participants in two groups at study completion at approximately 18 months
Operator rated overall procedure satisfaction (VAS)
Comparison of VAS scores
Measured: At study completion at approximately 18 months
Operator rated cough between the two procedures (VAS)
Comparison of VAS scores
Measured: At study completion at approximately 18 months
Overall duration of procedure
Comparison of time taken
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startDec 2015
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MediastinumStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karan Madan, All India Institute of Medical Sciences
- Investigators
- Randeep Guleria, Study chair, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704078
- Sponsor's protocol ID
- IEC/NP-419/09.10.2015
- Acronym
- TEAM
- Status last verified
- Aug 2017
- First submitted
- 25 Feb 2016
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparison of Trans-tracheal (EBUS-TBNA) Versus Trans-esophageal (EUS-B-FNA) Route as the Primary Approach for Fine Needle Aspiration of Mediastinal Lesions Using the Convex Probe Endobronchial Ultrasound (EBUS) Scope
- ClinicalTrials.gov ID
- NCT02704078
- Acronym / sponsor ID
- TEAM / IEC/NP-419/09.10.2015
- Conditions
- Mediastinum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 9 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.
Endobronchial Ultrasound Guided Transbronchial Needle aspiration (EBUS-TBNA) is a firmly established modality for diagnostic evaluation of mediastinal lesions. The procedure is routinely performed at the Department of Pulmonary Medicine and Sleep Disorders, AIIMS, New Delhi since 2012. Transesophageal approach for fine needle aspiration of mediastinal lesions using the Endobronchial Ultrasound (EBUS) scope [also described as Transesophageal Bronchoscopic Ultrasound Guided Fine Needle aspiration (EUS-B-FNA)] (also routinely performed in the department) and has been described as a safe and efficacious modality. EUS-B-FNA is usually employed when EBUS-TBNA is not feasible or excessive cough or secretions necessitate switch to esophageal route. We hypothesize that EUS-B-FNA as the primary approach has similar diagnostic performance as EBUS-TBNA and is associated with greater patient and operator rated procedure comfort and lesser requirement of anaesthesia medications for evaluation of patients with mediastinal lesions easily accessible with either of the two approaches.
We propose to undertake a prospective randomized comparison of Transesophageal (EUS-B-FNA) versus Transtracheal (EBUS-TBNA) approach for fine needle aspiration using the same EBUS scope in patients referred for endo-sonographic evaluation of mediastinal lesions. A total of 100 serial patients (with Subcarinal and/or Lower Left paratracheal located mediastinal lymphadenopathy at least >1cm in Short axis diameter) shall be included. After consent and preliminary investigations, patients shall be randomized equally into the two approaches. Procedure will be performed under local anaesthesia (topical lignocaine) and i.v. sedation (midazolam and fentanyl) in the bronchoscopy laboratory. The primary objective will be comparison of proportion of diagnostic and adequate aspirates in the two groups. Secondary objectives will include operator rated cough (VAS), Operator rated overall procedure satisfaction (VAS), dose of midazolam and fentanyl administered, lignocaine dose and total procedure duration.The primary data analysis shall be for the performance characteristics of the primary approach. All the aspirates shall be analysed by the same pathologist for final interpretation.
Detailed description
Objectives
Primary objective:
Comparison of Proportion of Adequate and Diagnostic Aspirates in the EUS-B-FNA versus EBUS-TBNA arms as the primary approach for mediastinal fine needle aspiration during Convex probe EBUS.
Secondary objectives
- Topical Anaesthetic requirement between the two groups
- Intravenous Sedative / analgesic requirement between the two groups
- Operator rated overall procedure satisfaction (VAS)
- Operator rated cough (VAS)
- Overall duration of procedure Methods Study Design: Prospective randomised study. Sample Size: Number of Patients: 100 (50 -EBUS-TBNA arm, 50- EUS-B-FNA arm)
Inclusion criteria:
- Age 18 years and Older
- Patients with predominant Subcarinal or Lower Left paratracheal located mediastinal lymphadenopathy/mediastinal lesions at least >1cm in Short axis diameter.
- Patients who give consent.
Exclusion criteria:
- Refusal of consent for the procedure
- Any contraindications to Bronchoscopy or Endobronchial Ultrasound procedures
- Pregnancy Controls: None For all patients, a targeted history will be obtained to screen for diabetes mellitus, systemic hypertension, bleeding disorders, cardiac disease, previous anaesthetic complications and any medication history including antiplatelet therapy. Baseline investigations like complete hemogram and prothrombin time will be done, and imaging prior to the procedure will include a chest radiograph and computed tomography (CT) scan of the chest (plain and contrast enhanced).
The patients will then be randomised to 2 groups of 50 patients each. 50 patients in one group will undergo Transtracheal (EBUS-TBNA) approach, whereas in the other group, 50 patients will undergo Transesophageal (EUS-B-FNA) route as the primary approach using the EBUS scope. Procedures will be performed under moderate sedation. Procedures will be performed in the Bronchoscopy Lab.
The size and characteristics of the mediastinal lymph nodes as visualised during EBUS/EUS will be recorded. The concerned mediastinal lymph nodes will be sampled by EBUS-TBNA/EUS-FNA under direct ultrasonic visualisation. The aspirates will be expressed on to slides and will be placed into alcohol cytology bottles. The slides will then be dispatched to the Cytopathology Lab for appropriate stains and further analysis. Lymph node core if obtained will be sent in formalin for Histopathological analysis. Post procedure, the patients will remain in observation for a few hours and will be discharged on the same day. A patient proforma will be completed for each patient separately. The size and stations of the sampled nodes will be recorded. The total duration of procedure, the nature and total dose of anaesthesia or sedation will also be recorded. A Visual-analogue scale (VAS) will be used to assess operator rated procedure related cough and overall operator rated procedure satisfaction.
Statistical Analysis - Descriptive statistics such as mean, median, standard deviation and range will be calculated for all continuous variables. Frequency distributions will be calculated for all qualitative data. Frequency data across categorical variables will be compared using chi-square and fisher's exact test. Among patients with adequate sample on EBUS-TBNA/EUS-B-FNA, sensitivity, specificity, accuracy, and positive and negative predictive values will be calculated using standard formulas. P-value of P<0.05 is considered as statistically significant.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EBUS-TBNA | Active comparator | Device: EBUS-TBNAMediastinal lymph node aspiration shall be performed transtracheally. |
| EUS-B-FNA | Experimental | Device: EUS-B-FNAMediastinal lymph node aspiration shall be performed transesophageally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years and Older
- Predominant Subcarinal or Lower Left paratracheal located mediastinal lymphadenopathy/mediastinal lesions at least >1cm in Short axis diameter.
- Patients who give consent
Key exclusion criteria (3 listed)
- Refusal of consent for the procedure
- Any contraindications to Bronchoscopy / Endobronchial Ultrasound
- Pregnancy
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-TBNAEBUS-TBNA - Patients in the Active comparator arm shall undergo mediastinal lymph node aspiration transtracheally using the EBUS scope | Device | EBUS-TBNA |
| EUS-B-FNAEUS-B-FNA - Patients in the experimental arm EUS-B-FNA shall undergo mediastinal lymph node aspiration transesophageally using the EBUS scope | Device | EUS-B-FNA |
Primary outcome
Diagnostic Sensitivity of EUS-B-FNA versus EBUS-TBNA
Time frame: At study completion at approximately 18 months
The diagnostic yield of EBUS-TBNA shall be compared with EUS-B-FNA ie comparison of the proportion of diagnostic aspirates between the EBUS-TBNA and the EUS-B-FNA groups
5 secondary outcomes
Topical Anaesthetic requirement between the two groups
Time frame: Comparing the mean doses of lignocaime administered in mg between the study participants in two groups at study completion at approximately 18 months
Intravenous Sedative / analgesic requirement between the two groups
Time frame: Compating the mean doses of sedative administered in mg between the study participants in two groups at study completion at approximately 18 months
Operator rated overall procedure satisfaction (VAS)
Time frame: At study completion at approximately 18 months
Operator rated cough between the two procedures (VAS)
Time frame: At study completion at approximately 18 months
Overall duration of procedure
Time frame: Intraoperative
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 18 Aug 2017.
- 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.
Randeep Guleria study chair
All India Institute of Medical Sciences
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 and EUS-B-FNA in people with Mediastinum, run by All India Institute of Medical Sciences at 1 site in India.
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 3 inclusion and 3 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 18 Aug 2017. 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 India. 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?
Diagnostic Sensitivity of EUS-B-FNA versus EBUS-TBNA (time frame: At study completion at approximately 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2017.