Lung CancerNCT01895166
EBUS-GS-TBLB With or Without Fluoroscopy for the Diagnosis of PPLs
A study testing EBUS-GS and X-ray in people with Lung Cancer, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of endobronchial ultrasound-guide sheath(EBUS-GS) for the diagnosis of peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- EBUS-GS and X-ray
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jul 2013to Jun 2014
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Individuals eligible for inclusion are patients that the CT scan appearance of the PPLs showed the longest diameter was more than 2 cm and solid lesions.
Who cannot join
- The lesion is close to the pleural membrane
- Refusal of participation
- Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, 200030
Jiayuan Sun, jysun1976@163.com
Jiayuan Sun, MD
About this study
Official title: Diagnostic Value of Endobronchial Ultrasound(EBUS) With a Guide Sheath(GS) for Peripheral Pulmonary Lesions(PPLs) Without Fluoroscopy: a Randomized Controlled Trial
The purpose of this study is to evaluate the efficacy and safety of endobronchial ultrasound-guide sheath(EBUS-GS) for the diagnosis of peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.
Read the detailed description
The investigators evaluated the efficacy and safety of transbronchial biopsy (TBB) and bronchial brushing by endobronchial ultrasonography (EBUS) with a guide sheath (GS) as a guide for diagnosing peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.The study is designed as a two-center prospective randomized controlled trial. The participating centers are Department of pulmonary medicine and endoscope center, Shanghai chest Hospital affiliated to Shanghai JiaoTong University School, China. Department of pulmonary medicine, Fukushima Medical University, Japan.Patients are divided into two groups, EBUS-GS-X-ray group and EBUS-GS group.Each subject will be randomized to each group.The study is expected to enroll 100 patients at 2 centers (China:75, Fukushima:25).
- Conditions
- Lung Cancer
- Being tested
- EBUS-GS, X-ray
- Keywords
- Endobronchial ultrasonography with a guide sheath, Peripheral pulmonary lesions, Transbronchial biopsy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBUS-GSProcedure or surgery
EBUS is performed using an endoscope ultrasound system , which is equipped with a 20-MHz mechanical radial-type probe (UM-S20-17S;Olympus) with an external diameter of 1.4 mm and a GS (K-201; Olympus).
X-rayProcedure or surgery
The radiograph fluoroscopy are performed when the probe and GS are confirmed to reach the lesion by EBUS images ,cytologic and pathologic specimens are obtained under fluoroscopic guidance.
| Study group | Role | What they receive |
|---|---|---|
| EBUS-GS group | Experimental | The EBUS probe and GS are confirmed to reach the lesion by EBUS images alone, cytologic and pathologic specimens are obtained without fluoroscopic guidance. Receives: Procedure: EBUS-GS |
| EBUS-GS-X-ray group | Active comparator | The EBUS probe and GS are confirmed to reach the lesion by EBUS images and radiograph fluoroscopy, cytologic and pathologic specimens are obtained under fluoroscopic guidance. Receives: Procedure: EBUS-GS; Procedure: X-ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of diagnostic value of EBUS-GS-TBLB with fluoroscopy as compared to EBUS-GS-TBLB alone
The diagnostic value mean sensitivity and specificity in two groups
Measured: Up to half year
Secondary outcomes (1)
The difference of complications of EBUS-GS-TBLB with fluoroscopy as compared to EBUS-GS-TBLB alone
Complications mean a composite of operation-related serious adverse events (pneumothorax, bleeding, etc.) during and after the operation in two groups
Measured: Up to half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fukushima Medical University
- Responsible party
- Principal investigator, Jiayuan Sun, Shanghai Chest Hospital
- Investigators
- Jiayuan Sun, MD, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895166
- Sponsor's protocol ID
- SHCHE201301
- Status last verified
- Jul 2013
- First submitted
- 25 Mar 2013
- Last updated
- 31 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kurimoto N, Miyazawa T, Okimasa S, Maeda A, Oiwa H, Miyazu Y, Murayama M. Endobronchial ultrasonography using a guide sheath increases the ability to diagnose peripheral pulmonary lesions endoscopically. Chest. 2004 Sep;126(3):959-65. doi: 10.1378/chest.126.3.959.
PubMed 15364779Yoshikawa M, Sukoh N, Yamazaki K, Kanazawa K, Fukumoto S, Harada M, Kikuchi E, Munakata M, Nishimura M, Isobe H. Diagnostic value of endobronchial ultrasonography with a guide sheath for peripheral pulmonary lesions without X-ray fluoroscopy. Chest. 2007 Jun;131(6):1788-93. doi: 10.1378/chest.06-2506.
PubMed 17565021Yamada N, Yamazaki K, Kurimoto N, Asahina H, Kikuchi E, Shinagawa N, Oizumi S, Nishimura M. Factors related to diagnostic yield of transbronchial biopsy using endobronchial ultrasonography with a guide sheath in small peripheral pulmonary lesions. Chest. 2007 Aug;132(2):603-8. doi: 10.1378/chest.07-0637. Epub 2007 Jun 15.
PubMed 17573504Steinfort DP, Khor YH, Manser RL, Irving LB. Radial probe endobronchial ultrasound for the diagnosis of peripheral lung cancer: systematic review and meta-analysis. Eur Respir J. 2011 Apr;37(4):902-10. doi: 10.1183/09031936.00075310. Epub 2010 Aug 6.
PubMed 20693253
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Endobronchial Ultrasound(EBUS) With a Guide Sheath(GS) for Peripheral Pulmonary Lesions(PPLs) Without Fluoroscopy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01895166
- Acronym / sponsor ID
- SHCHE201301
- Conditions
- Lung Cancer
- Keywords
- Endobronchial ultrasonography with a guide sheath, Peripheral pulmonary lesions, Transbronchial biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- Fukushima Medical University
- Study start
- Jul 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 10 Jul 2013 (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 purpose of this study is to evaluate the efficacy and safety of endobronchial ultrasound-guide sheath(EBUS-GS) for the diagnosis of peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.
Detailed description
The investigators evaluated the efficacy and safety of transbronchial biopsy (TBB) and bronchial brushing by endobronchial ultrasonography (EBUS) with a guide sheath (GS) as a guide for diagnosing peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.The study is designed as a two-center prospective randomized controlled trial. The participating centers are Department of pulmonary medicine and endoscope center, Shanghai chest Hospital affiliated to Shanghai JiaoTong University School, China. Department of pulmonary medicine, Fukushima Medical University, Japan.Patients are divided into two groups, EBUS-GS-X-ray group and EBUS-GS group.Each subject will be randomized to each group.The study is expected to enroll 100 patients at 2 centers (China:75, Fukushima:25).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EBUS-GS group | Experimental | Procedure: EBUS-GSThe EBUS probe and GS are confirmed to reach the lesion by EBUS images alone, cytologic and pathologic specimens are obtained without fluoroscopic guidance. |
| EBUS-GS-X-ray group | Active comparator | Procedure: EBUS-GS, Procedure: X-rayThe EBUS probe and GS are confirmed to reach the lesion by EBUS images and radiograph fluoroscopy, cytologic and pathologic specimens are obtained under fluoroscopic guidance. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Individuals eligible for inclusion are patients that the CT scan appearance of the PPLs showed the longest diameter was more than 2 cm and solid lesions.
Key exclusion criteria (3 listed)
- The lesion is close to the pleural membrane
- Refusal of participation
- Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy
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-GSEBUS is performed using an endoscope ultrasound system , which is equipped with a 20-MHz mechanical radial-type probe (UM-S20-17S;Olympus) with an external diameter of 1.4 mm and a GS (K-201; Olympus). | Procedure or surgery | EBUS-GS group, EBUS-GS-X-ray group |
| X-rayThe radiograph fluoroscopy are performed when the probe and GS are confirmed to reach the lesion by EBUS images ,cytologic and pathologic specimens are obtained under fluoroscopic guidance. | Procedure or surgery | EBUS-GS-X-ray group |
Primary outcome
The difference of diagnostic value of EBUS-GS-TBLB with fluoroscopy as compared to EBUS-GS-TBLB alone
Time frame: Up to half year
The diagnostic value mean sensitivity and specificity in two groups
1 secondary outcome
The difference of complications of EBUS-GS-TBLB with fluoroscopy as compared to EBUS-GS-TBLB alone
Time frame: Up to half year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2013.
- Background: PubMed 15364779Kurimoto N, Miyazawa T, Okimasa S, Maeda A, Oiwa H, Miyazu Y, Murayama M. Endobronchial ultrasonography using a guide sheath increases the ability to diagnose peripheral pulmonary lesions endoscopically. Chest. 2004 Sep;126(3):959-65. doi: 10.1378/chest.126.3.959.
- Background: PubMed 17565021Yoshikawa M, Sukoh N, Yamazaki K, Kanazawa K, Fukumoto S, Harada M, Kikuchi E, Munakata M, Nishimura M, Isobe H. Diagnostic value of endobronchial ultrasonography with a guide sheath for peripheral pulmonary lesions without X-ray fluoroscopy. Chest. 2007 Jun;131(6):1788-93. doi: 10.1378/chest.06-2506.
- Background: PubMed 17573504Yamada N, Yamazaki K, Kurimoto N, Asahina H, Kikuchi E, Shinagawa N, Oizumi S, Nishimura M. Factors related to diagnostic yield of transbronchial biopsy using endobronchial ultrasonography with a guide sheath in small peripheral pulmonary lesions. Chest. 2007 Aug;132(2):603-8. doi: 10.1378/chest.07-0637. Epub 2007 Jun 15.
- Background: PubMed 20693253Steinfort DP, Khor YH, Manser RL, Irving LB. Radial probe endobronchial ultrasound for the diagnosis of peripheral lung cancer: systematic review and meta-analysis. Eur Respir J. 2011 Apr;37(4):902-10. doi: 10.1183/09031936.00075310. Epub 2010 Aug 6.
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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.
Jiayuan Sun, MD principal investigator
Shanghai Chest Hospital
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-GS and X-ray in people with Lung Cancer, run by Shanghai Chest Hospital at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 31 Jul 2013. 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 China. 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?
Contact Jiayuan Sun, MD (86-21-22200000-1421, jysun1976@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference of diagnostic value of EBUS-GS-TBLB with fluoroscopy as compared to EBUS-GS-TBLB alone (time frame: Up to half year). 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 NCT01895166, 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 31 Jul 2013; AzTrials last refreshed its copy on 31 Oct 2026.