Lung NeoplasmsNCT00415337
Endobronchial Ultrasound Guided Transbronchial Lung Biopsy With or Without Guide Sheath in Lung Tumors and the Analysis of Echoic Patterns of Lung Tumors and Mediastinal Lymph Nodes, and the Association Between Diagnostic Yield of Transbronchial Lung Biopsy and EBUS Echoic Features.
An observational study of Lung Neoplasms, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
1. Endobronchial ultrasonography (EBUS) is useful in localizing peripheral lung lesions. The EBUS, further combined with the guide sheath (GS) technique, has been reported to increase the yield of transbronchial biopsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- endobronchial ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2007to not given
- 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: Patient with radiologically confirmed peripheral lung mass
Who may be able to join
- Patient with radiologically confirmed peripheral lung mass
Who cannot join
- Patient clinically not indicated for bronchoscopy exam within the abovementioned cohort
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Thoracic Medicine, Chang Gung Memorial Hospital
Taipei, Taipei, 199
About this study
- Endobronchial ultrasonography (EBUS) is useful in localizing peripheral lung lesions. The EBUS, further combined with the guide sheath (GS) technique, has been reported to increase the yield of transbronchial biopsy. However, there are no reports comparing the GS technique and the traditional EBUS technique in diagnosing the peripheral lung tumor.
- Previous reports have revealed that several characteristic echoic patterns correlate well with the histopathological findings of benign and malignant lesions. Therefore, EBUS may also be useful in the differential diagnosis of malignant lesions of the lung.
- Conditions
- Lung Neoplasms
- Being tested
- endobronchial ultrasound
- Keywords
- lung, neoplasm, bronchoscopy, ultrasonography, histology
- Medical subject headings
- Lung Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endobronchial ultrasoundProcedure or surgery
EBUS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study startApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Observational
- Observational model
- Cohort
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHIH-HSI KUO, Chang Gung Memorial Hospital
- Investigators
- Han-Pin Kuo, Chair, Study chair, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415337
- Sponsor's protocol ID
- ebus101101
- Status last verified
- Dec 2011
- First submitted
- 21 Dec 2006
- Last updated
- 14 Dec 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endobronchial Ultrasound Guided Transbronchial Lung Biopsy With or Without Guide Sheath in Lung Tumors and the Analysis of Echoic Patterns of Lung Tumors and Mediastinal Lymph Nodes, and the Association Between Diagnostic Yield of Transbronchial Lung Biopsy and EBUS Echoic Features.
- ClinicalTrials.gov ID
- NCT00415337
- Acronym / sponsor ID
- ebus101101
- Conditions
- Lung Neoplasms
- Keywords
- lung, neoplasm, bronchoscopy, ultrasonography, histology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Apr 2007
- First posted
- 22 Dec 2006 (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 ultrasonography (EBUS) is useful in localizing peripheral lung lesions. The EBUS, further combined with the guide sheath (GS) technique, has been reported to increase the yield of transbronchial biopsy. However, there are no reports comparing the GS technique and the traditional EBUS technique in diagnosing the peripheral lung tumor.
- Previous reports have revealed that several characteristic echoic patterns correlate well with the histopathological findings of benign and malignant lesions. Therefore, EBUS may also be useful in the differential diagnosis of malignant lesions of the lung.
Study design
- Observational model
- Cohort
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with radiologically confirmed peripheral lung mass
Key inclusion criteria (1 listed)
- Patient with radiologically confirmed peripheral lung mass
Key exclusion criteria (1 listed)
- Patient clinically not indicated for bronchoscopy exam within the abovementioned cohort
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 |
|---|---|---|
| endobronchial ultrasoundEBUS | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2011.
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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.
Han-Pin Kuo, Chair study chair
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasms, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Dec 2011. 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 Taiwan. 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?
Results are not available in the source record.
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.
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 14 Dec 2011.