Lung CancerNCT02813603
Comparison of 22-gauge and 19-gauge Aspiration Needle During EBUS-TBNA
An observational study of Lung Cancer, run by University Hospital, Essen at 2 sites in 2 countries.
Trial summary
Investigators intend to compare the 19-gauge needle and the 22-gauge-needle during EBUS-TBNA concerning the diagnostic yield, the quality and quantity of each biopsy needle without raising the rate of complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- EBUS
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2016to Mar 2018
- Phase
- Observational
- 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
Study population: 100 Patients with lung cancer and enlarged lymph nodes will be included in this study
Who may be able to join
- Male or female patients aged over 18
- Patients signed written informed consent
- Mediastinal or hilar enlarged lymph nodes (>10mm) in short axis radiological or clinical findings likely for lung cancer
Who cannot join
- Severe impairment of any organs, with do not enable anaesthesia
- Quick <80%, INR >1,5, thrombocytes <50/nl or PTT>120sec
- Other clinically relevant medical or psychological diseases, which affect the patients judgement or ability to participate in this study.
- Insufficient language ability (spoken and written German)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Ruhrlandklinik, University Hospital Essen
Essen, North Rhine-Westphalia, 45147
About this study
Official title: Comparison of the Diagnostic Yield Between Various Endobronchial Ultrasound-guided-transbronchial Needles (EBUS-TBN) to Evaluate Suspect Mediastinal and Hilar Lymph Nodes
Investigators intend to compare the 19-gauge needle and the 22-gauge-needle during EBUS-TBNA concerning the diagnostic yield, the quality and quantity of each biopsy needle without raising the rate of complications.
Read the detailed description
Investigators intend to compare the 19-gauge needle and the 22-gauge-needle during EBUS-TBNA performed in rigid bronchoscopy for patients with probable lung cancer diagnosis and enlarged mediastinal lymph nodes.
- Conditions
- Lung Cancer
- Being tested
- EBUS
- Keywords
- EBUS-TBNA, staging, lymph node metastases
- Medical subject headings
- Lung Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBUSProcedure or surgery
19G and 22G EBUS needles are compared in a randomized prospective way in lung cancer patients with enlarged mediastinal lymph nodes.
| Study group | Role | What they receive |
|---|---|---|
| Study Product (19-gauge) | After randomization, the subject undergo EBUS-TBNA either with the 19-gauge needle or the 22-gauge needle Receives: Procedure: EBUS | |
| Control Intervention (22-gauge) | After randomization, the subject undergo EBUS-TBNA either with the 19-gauge needle or the 22-gauge needle Receives: Procedure: EBUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
sample weight
Measured: February 2017
Secondary outcomes (1)
The number of complications like bleeding, infections, pneumothorax and pain
Measured: February 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionMar 2018
- Study completionMar 2018
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 Lung CancerStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich
- Responsible party
- Principal investigator, Kaid Darwiche, University Hospital, Essen
- Investigators
- Kaid Darwiche, PD Dr. med., Study director, supervising doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813603
- Sponsor's protocol ID
- EBUS19VS22
- Status last verified
- Jul 2018
- First submitted
- 16 Jun 2016
- Last updated
- 12 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Wolters C, Darwiche K, Franzen D, Hager T, Bode-Lesnievska B, Kneuertz PJ, He K, Koenig M, Freitag L, Wei L, Eisenmann S, Taube C, Weinreich G, Oezkan F. A Prospective, Randomized Trial for the Comparison of 19-G and 22-G Endobronchial Ultrasound-Guided Transbronchial Aspiration Needles; Introducing a Novel End Point of Sample Weight Corrected for Blood Content. Clin Lung Cancer. 2019 May;20(3):e265-e273. doi: 10.1016/j.cllc.2019.02.019. Epub 2019 Mar 4.
PubMed 30914312
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Diagnostic Yield Between Various Endobronchial Ultrasound-guided-transbronchial Needles (EBUS-TBN) to Evaluate Suspect Mediastinal and Hilar Lymph Nodes
- ClinicalTrials.gov ID
- NCT02813603
- Acronym / sponsor ID
- EBUS19VS22
- Conditions
- Lung Cancer
- Keywords
- EBUS-TBNA, staging, lymph node metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Collaborators
- University Hospital, Zürich
- Study start
- May 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 27 Jun 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.
Investigators intend to compare the 19-gauge needle and the 22-gauge-needle during EBUS-TBNA concerning the diagnostic yield, the quality and quantity of each biopsy needle without raising the rate of complications.
Detailed description
Investigators intend to compare the 19-gauge needle and the 22-gauge-needle during EBUS-TBNA performed in rigid bronchoscopy for patients with probable lung cancer diagnosis and enlarged mediastinal lymph nodes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Product (19-gauge) | – | Procedure: EBUSAfter randomization, the subject undergo EBUS-TBNA either with the 19-gauge needle or the 22-gauge needle |
| Control Intervention (22-gauge) | – | Procedure: EBUSAfter randomization, the subject undergo EBUS-TBNA either with the 19-gauge needle or the 22-gauge needle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 Patients with lung cancer and enlarged lymph nodes will be included in this study
Key inclusion criteria (3 listed)
- Male or female patients aged over 18
- Patients signed written informed consent
- Mediastinal or hilar enlarged lymph nodes (>10mm) in short axis radiological or clinical findings likely for lung cancer
Key exclusion criteria (4 listed)
- Severe impairment of any organs, with do not enable anaesthesia
- Quick <80%, INR >1,5, thrombocytes <50/nl or PTT>120sec
- Other clinically relevant medical or psychological diseases, which affect the patients judgement or ability to participate in this study.
- Insufficient language ability (spoken and written German)
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 |
|---|---|---|
| EBUS19G and 22G EBUS needles are compared in a randomized prospective way in lung cancer patients with enlarged mediastinal lymph nodes. | Procedure or surgery | Control Intervention (22-gauge), Study Product (19-gauge) |
Primary outcome
sample weight
Time frame: February 2017
1 secondary outcome
The number of complications like bleeding, infections, pneumothorax and pain
Time frame: February 2017
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 12 Jul 2018.
- Derived from this study: PubMed 30914312Wolters C, Darwiche K, Franzen D, Hager T, Bode-Lesnievska B, Kneuertz PJ, He K, Koenig M, Freitag L, Wei L, Eisenmann S, Taube C, Weinreich G, Oezkan F. A Prospective, Randomized Trial for the Comparison of 19-G and 22-G Endobronchial Ultrasound-Guided Transbronchial Aspiration Needles; Introducing a Novel End Point of Sample Weight Corrected for Blood Content. Clin Lung Cancer. 2019 May;20(3):e265-e273. doi: 10.1016/j.cllc.2019.02.019. Epub 2019 Mar 4.
- Individual participant dataSharing planned: No
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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.
Kaid Darwiche, PD Dr. med. study director
supervising doctor
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by University Hospital, Essen at 2 sites in 2 countries.
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 4 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 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. 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?
sample weight (time frame: February 2017). 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 NCT02813603, 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 12 Jul 2018.