Lung NeoplasmsNCT02740400
A Comparison Between EBUS-GS and CT-guided Lung Biopsy in Diagnosis of Peripheral Pulmonary Lesions.
A study testing EBUS-GS and CT-TTNB in people with Lung Neoplasms, run by Peking University People's Hospital at 1 site in China.
Trial summary
This is a randomized controlled trail aiming at comparing the diagnostic value and safety of endobronchial ultrasonography with a guide sheath(EBUS-GS) and computed tomography-guided transthoracic needle biopsy(CT-TTNB) for peripheral pulmonary lesions (PPLs). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- EBUS-GS and CT-TTNB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Lesions presented as nodule or mass in CT imaging and located at the distal end of the segmental bronchus; invisible under normal bronchoscope; no pathological results were obtained before biopsy procedure; patients can tolerate video assisted thoracic surgery(VATS) lobectomy or wedge resection; all patients provided written informed consent.
Who cannot join
- Presence of central pulmonary lesion and visible under the bronchoscope; lesions presented as exudative or consolidation in CT imaging; the location was unsuitable for CT-guided biopsy; presence of pneumothorax or pleural effusion patients have contraindication for EBUS-GS or CT-TTNB,such as cardiopulmonary dysfunction, cachexia, thrombocytopenia or coagulopathy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People'S Hospital
Beijing, Beijing Municipality, +86-010
Guanchao Jiang, M.D, +86-13911196927, jiangguanchao@263.net
Guanchao Jiang, M.D
About this study
Official title: Endobronchial Ultrasonography With a Guide Sheath Versus Computed Tomography-guided Transthoracic Needle Biopsy in the Diagnosis of Peripheral Pulmonary Lesions
This is a randomized controlled trail aiming at comparing the diagnostic value and safety of endobronchial ultrasonography with a guide sheath(EBUS-GS) and computed tomography-guided transthoracic needle biopsy(CT-TTNB) for peripheral pulmonary lesions (PPLs). Patients eligible for the inclusion criteria are diagnosed using either EBUS-GS or CT-TTNB randomly. The diagnostic indicators such as sensitivity, specificity, and accuracy are compared between the two groups. Post-procedure complications are recorded.
Read the detailed description
CT-TTNB is widely used in the diagnosis of PPLs and its sensitivity for lung cancer remains as high as 90%. However, the relatively high rate of complications such as pneumothorax, hemoptysis, pulmonary hemorrhage, severe chest pain, and bad tolerance in patients limits its application.
EBUS-GS is an emerging technology, Kurimoto in 2004 performed transbronchial lung biopsy(TBLB) assisted by EBUS-GS, and the sensitivity of diagnosing lung cancer was 81%, and it was proved to be a safe procedure with very small amount of pneumothorax and hemoptysis.
Till now there is only one randomized controlled study comparing the diagnostic value of CT-TTNB and EBUS-GS; however, it did not complete the enrollment of patients on schedule. In addition, all the other studies were retrospective. Hence this prospective study was performed to determine the diagnostic value and safety of EBUS-GS and CT-TTNB for PPLs.
- Conditions
- Lung Neoplasms
- Being tested
- EBUS-GS, CT-TTNB
- Keywords
- Endobronchial ultrasonography, guided sheath, diagnosis, accuracy, complication
- Medical subject headings
- Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBUS-GSProcedure or surgery
The equipment for EBUS-GS includes super-thin bronchoscope BF-P260F, endobronchial ultrasonic system EU-M30S, ultrasonic probe UM-S20-17S, and guided sheath kit K201. All facilities are provided by Olympus Co. The EBUS-GS procedure was performed by thoracic surgeons. The patient was in supine position, under general anesthesia, and provided ventilatation through laryngeal mask. First, the operator placed super-thin bronchoscope into the bronchus of interest, inserted the probe covered with GS through a work channel. Later, adjusted the bronchoscope and probe to obtain classical ultrasonic graphs. The assistant fixed the bronchoscope, pulled the probe out, and placed the brush and biopsy forceps, respectively, through the GS. This process was assisted using x-ray fluoroscope or not.
CT-TTNBProcedure or surgery
The devices for CT-TTNB includes Lightspeed VCT spiral CT(GE co.) and Quickcore(COOK Co.) biopsy kit. The kit includes a sheath(5cm in length and 16G in outer diameter) and a automatic biopsy needle(15cm in length and 18G in outer diameter). The patient stays in supine, prone or lateral position according to the lesion's location. The first chest CT scan is performed to confirm the location of the lesion and make an optimal entry point. Then, after sterilization and 2% lidocaine local anesthesia, the sheath is stabbed into chest wall through the entry point. The second CT scan is performed to make sure that the sheath stays in proper angle and depth. The operator places the needle through the sheath and enter the lesion. Then fire the biopsy needle and repeat the procedure twice or third time. The last CT scan is conducted to determine whether pneumothorax or hemorrhage occurred.
| Study group | Role | What they receive |
|---|---|---|
| CT-TTNB | Experimental | patients receive CT-TTNB to diagnose PPLs. Receives: Procedure: CT-TTNB |
| EBUS-GS | Experimental | patients receive EBUS-GS to diagnose PPLs. Receives: Procedure: EBUS-GS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety. It is measured by the incidence rate of all adverse events during or after EBUS-GS or CT-TTNB.
Adverse events include: 1)pneumothorax or pulmonary hemorrhage which are observed in CT scan after CT-TTNB; 2)patient's complaint of chest pain or dyspnea after returning the ward, and bedside X-ray shows pneumothorax or decreased respiratory auscultation，and drainage should be performed; 3)postoperative hemoptysis and usage of hemostatic agents;4)severe chest pain, but no pneumothorax in chest film, no T wave or ST segment changes in ECG,and analgesics should be used;5)new tumor or subcutaneous nodules are found in the needle channel during the follow-up;6)other adverse events: such as pleural reaction; arrhythmia, continuous hypoxemia or persistent hypotension during anesthesia process; hoarseness after EBUS-GS,and cricoarytenoid joint dislocation is found by laryngoscope.
Measured: 30 days
Secondary outcomes (1)
Diagnostic value. It is measured by the diagnostic accurate rate between the two groups.
If the pathological results from EBUS-GS or CT-TTNB show lung cancer, metastatic carcinoma or other malignant tumors, they are recorded as accurate.
If the patient undergoes the following surgical treatment, the histological results from the resected tissues are "golden standard".
If the pathological diagnosis is non-neoplastic and the patient does not receive surgery, the follow-up radiographic findings will decide. If there is no change or reduction in size, it is considered as accurate, otherwise false negative.
If the biopsy diagnosis are mucosa, cartilage, coagulation, necrosis or other description that can not make a predisposed diagnosis. They are also recorded as negative results.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startApr 2015
- Primary completionJun 2016 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmsStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Wang, Peking University People's Hospital
- Investigators
- Guanchao Jiang, M.D., Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740400
- Sponsor's protocol ID
- CDI2014-2-4084
- Status last verified
- Apr 2016
- First submitted
- 5 Apr 2016
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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 15364779Hiraki T, Mimura H, Gobara H, Iguchi T, Fujiwara H, Sakurai J, Matsui Y, Inoue D, Toyooka S, Sano Y, Kanazawa S. CT fluoroscopy-guided biopsy of 1,000 pulmonary lesions performed with 20-gauge coaxial cutting needles: diagnostic yield and risk factors for diagnostic failure. Chest. 2009 Dec;136(6):1612-1617. doi: 10.1378/chest.09-0370. Epub 2009 May 8.
PubMed 19429718Fielding DI, Chia C, Nguyen P, Bashirzadeh F, Hundloe J, Brown IG, Steinke K. Prospective randomised trial of endobronchial ultrasound-guide sheath versus computed tomography-guided percutaneous core biopsies for peripheral lung lesions. Intern Med J. 2012 Aug;42(8):894-900. doi: 10.1111/j.1445-5994.2011.02707.x.
PubMed 22212110Wang Memoli JS, Nietert PJ, Silvestri GA. Meta-analysis of guided bronchoscopy for the evaluation of the pulmonary nodule. Chest. 2012 Aug;142(2):385-393. doi: 10.1378/chest.11-1764.
PubMed 21980059Hayama M, Izumo T, Matsumoto Y, Chavez C, Tsuchida T, Sasada S. Complications with Endobronchial Ultrasound with a Guide Sheath for the Diagnosis of Peripheral Pulmonary Lesions. Respiration. 2015;90(2):129-35. doi: 10.1159/000431383. Epub 2015 Jun 19.
PubMed 26112297
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endobronchial Ultrasonography With a Guide Sheath Versus Computed Tomography-guided Transthoracic Needle Biopsy in the Diagnosis of Peripheral Pulmonary Lesions
- ClinicalTrials.gov ID
- NCT02740400
- Acronym / sponsor ID
- CDI2014-2-4084
- Conditions
- Lung Neoplasms
- Keywords
- Endobronchial ultrasonography, guided sheath, diagnosis, accuracy, complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 15 Apr 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 is a randomized controlled trail aiming at comparing the diagnostic value and safety of endobronchial ultrasonography with a guide sheath(EBUS-GS) and computed tomography-guided transthoracic needle biopsy(CT-TTNB) for peripheral pulmonary lesions (PPLs). Patients eligible for the inclusion criteria are diagnosed using either EBUS-GS or CT-TTNB randomly. The diagnostic indicators such as sensitivity, specificity, and accuracy are compared between the two groups. Post-procedure complications are recorded.
Detailed description
CT-TTNB is widely used in the diagnosis of PPLs and its sensitivity for lung cancer remains as high as 90%. However, the relatively high rate of complications such as pneumothorax, hemoptysis, pulmonary hemorrhage, severe chest pain, and bad tolerance in patients limits its application.
EBUS-GS is an emerging technology, Kurimoto in 2004 performed transbronchial lung biopsy(TBLB) assisted by EBUS-GS, and the sensitivity of diagnosing lung cancer was 81%, and it was proved to be a safe procedure with very small amount of pneumothorax and hemoptysis.
Till now there is only one randomized controlled study comparing the diagnostic value of CT-TTNB and EBUS-GS; however, it did not complete the enrollment of patients on schedule. In addition, all the other studies were retrospective. Hence this prospective study was performed to determine the diagnostic value and safety of EBUS-GS and CT-TTNB for PPLs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT-TTNB | Experimental | Procedure: CT-TTNBpatients receive CT-TTNB to diagnose PPLs. |
| EBUS-GS | Experimental | Procedure: EBUS-GSpatients receive EBUS-GS to diagnose PPLs. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Lesions presented as nodule or mass in CT imaging and located at the distal end of the segmental bronchus; invisible under normal bronchoscope; no pathological results were obtained before biopsy procedure; patients can tolerate video assisted thoracic surgery(VATS) lobectomy or wedge resection; all patients provided written informed consent.
Key exclusion criteria (1 listed)
- Presence of central pulmonary lesion and visible under the bronchoscope; lesions presented as exudative or consolidation in CT imaging; the location was unsuitable for CT-guided biopsy; presence of pneumothorax or pleural effusion patients have contraindication for EBUS-GS or CT-TTNB,such as cardiopulmonary dysfunction, cachexia, thrombocytopenia or coagulopathy.
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-GSThe equipment for EBUS-GS includes super-thin bronchoscope BF-P260F, endobronchial ultrasonic system EU-M30S, ultrasonic probe UM-S20-17S, and guided sheath kit K201. All facilities are provided by Olympus Co. The EBUS-GS procedure was performed by thoracic surgeons. The patient was in supine position, under general anesthesia, and provided ventilatation through laryngeal mask. First, the operator placed super-thin bronchoscope into the bronchus of interest, inserted the probe covered with GS through a work channel. Later, adjusted the bronchoscope and probe to obtain classical ultrasonic graphs. The assistant fixed the bronchoscope, pulled the probe out, and placed the brush and biopsy forceps, respectively, through the GS. This process was assisted using x-ray fluoroscope or not. | Procedure or surgery | EBUS-GS |
| CT-TTNBThe devices for CT-TTNB includes Lightspeed VCT spiral CT(GE co.) and Quickcore(COOK Co.) biopsy kit. The kit includes a sheath(5cm in length and 16G in outer diameter) and a automatic biopsy needle(15cm in length and 18G in outer diameter). The patient stays in supine, prone or lateral position according to the lesion's location. The first chest CT scan is performed to confirm the location of the lesion and make an optimal entry point. Then, after sterilization and 2% lidocaine local anesthesia, the sheath is stabbed into chest wall through the entry point. The second CT scan is performed to make sure that the sheath stays in proper angle and depth. The operator places the needle through the sheath and enter the lesion. Then fire the biopsy needle and repeat the procedure twice or third time. The last CT scan is conducted to determine whether pneumothorax or hemorrhage occurred. | Procedure or surgery | CT-TTNB |
Primary outcome
Safety. It is measured by the incidence rate of all adverse events during or after EBUS-GS or CT-TTNB.
Time frame: 30 days
Adverse events include: 1)pneumothorax or pulmonary hemorrhage which are observed in CT scan after CT-TTNB; 2)patient's complaint of chest pain or dyspnea after returning the ward, and bedside X-ray shows pneumothorax or decreased respiratory auscultation，and drainage should be performed; 3)postoperative hemoptysis and usage of hemostatic agents;4)severe chest pain, but no pneumothorax in chest film, no T wave or ST segment changes in ECG,and analgesics should be used;5)new tumor or subcutaneous nodules are found in the needle channel during the follow-up;6)other adverse events: such as pleural reaction; arrhythmia, continuous hypoxemia or persistent hypotension during anesthesia process; hoarseness after EBUS-GS,and cricoarytenoid joint dislocation is found by laryngoscope.
1 secondary outcome
Diagnostic value. It is measured by the diagnostic accurate rate between the two groups.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Results publication: 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.
- Results publication: PubMed 19429718Hiraki T, Mimura H, Gobara H, Iguchi T, Fujiwara H, Sakurai J, Matsui Y, Inoue D, Toyooka S, Sano Y, Kanazawa S. CT fluoroscopy-guided biopsy of 1,000 pulmonary lesions performed with 20-gauge coaxial cutting needles: diagnostic yield and risk factors for diagnostic failure. Chest. 2009 Dec;136(6):1612-1617. doi: 10.1378/chest.09-0370. Epub 2009 May 8.
- Results publication: PubMed 22212110Fielding DI, Chia C, Nguyen P, Bashirzadeh F, Hundloe J, Brown IG, Steinke K. Prospective randomised trial of endobronchial ultrasound-guide sheath versus computed tomography-guided percutaneous core biopsies for peripheral lung lesions. Intern Med J. 2012 Aug;42(8):894-900. doi: 10.1111/j.1445-5994.2011.02707.x.
- Results publication: PubMed 21980059Wang Memoli JS, Nietert PJ, Silvestri GA. Meta-analysis of guided bronchoscopy for the evaluation of the pulmonary nodule. Chest. 2012 Aug;142(2):385-393. doi: 10.1378/chest.11-1764.
- Results publication: PubMed 26112297Hayama M, Izumo T, Matsumoto Y, Chavez C, Tsuchida T, Sasada S. Complications with Endobronchial Ultrasound with a Guide Sheath for the Diagnosis of Peripheral Pulmonary Lesions. Respiration. 2015;90(2):129-35. doi: 10.1159/000431383. Epub 2015 Jun 19.
- 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.
Guanchao Jiang, M.D. principal investigator
Peking University People's 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 CT-TTNB in people with Lung Neoplasms, run by Peking University People's 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 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 15 Apr 2016. 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 Guanchao Jiang, M.D. (+86-13611196927, jiangguanchao@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety. It is measured by the incidence rate of all adverse events during or after EBUS-GS or CT-TTNB. (time frame: 30 days). 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 NCT02740400, which also lists 5 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 15 Apr 2016.