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Lung NeoplasmOCTGTBIPPLNCT06419114

Exploration of Optical Coherence Tomography-Guided Transbronchial Biopsy in Peripheral Pulmonary Lesions

An observational study of Lung Neoplasm, run by Sichuan Provincial People's Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In this prospective analysis, investigators collected and evaluated data from patients who underwent TBB at the Respiratory Endoscopy Center of Sichuan Provincial People's Hospital. The procedures utilized a novel approach combining OCT with R-EBUS for guidance. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Neoplasm
What is being tested?
Optical Coherence Tomography
Type of treatment
Medical device
How many people
150 participants
Where
1 siteChina
Study dates
1 Mar 2024to 31 Dec 2024
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: (1) voluntary participation and written informed consent signed, (2) age ≥ 18 years old, (3) the platelets count and PT, APTT tests were normal, (4) normal ECG, (5) found PPL's by chest computed tomography (CT) within 2 weeks and (6) could not detect the lesions through routine diagnostic bronchoscopy.

The inclusion criteria of this study were as followed: (1)Clinical diagnosis of PPL's by chest computed tomography (CT) within 2 weeks, (2)voluntary participation and written informed consent signed, (3) age ≥ 18 years old, (4) the platelets count and PT, APTT tests were normal, (5) normal ECG and (6) could not detect the lesions through routine diagnostic bronchoscopy. The exclusion criteria of this study were as followed: (1) patients with contraindication of bronchoscopy (such as respiratory failure and acute cardio-cerebrovascular events), (2) patients who refuse biopsy because of physical reasons or personal wishes, (3) patients with the objective reasons (such as abundant blood supply around the lesion) who could not complete the biopsy, (4) patients who are participating in other clinical studies, (5) patients with poor compliance who are believed by the researchers to be unable to cooperate for the completion of the examination and follow-up, and (6) women who were pregnant.

Trial locations and contacts

1 site in 1 country.

Guanghong Zhou, master contact

8618302880040

zhough0526@163.com

China1 site, 1 recruiting
  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

    Guanghong Zhou, master, 18302880040, zhough0526@163.com

    Recruiting

Other trials in China

About this study

In this prospective analysis, investigators collected and evaluated data from patients who underwent TBB at the Respiratory Endoscopy Center of Sichuan Provincial People's Hospital. The procedures utilized a novel approach combining OCT with R-EBUS for guidance. Eligibility for participation was determined based on established guidelines for the application of diagnostic flexible bronchoscopy in adults.

The admission criteria of this study were as followed: (1) voluntary participation and written informed consent signed, (2) age ≥ 18 years old, (3) the platelets count and PT, APTT tests were normal, (4) normal ECG, (5) found PPL's by chest computed tomography (CT) within 2 weeks and (6) could not detect the lesions through routine diagnostic bronchoscopy. The exclusion criteria of this study were as followed: (1) patients with contraindication of bronchoscopy (such as respiratory failure and acute cardio-cerebrovascular events), (2) patients who refuse biopsy because of physical reasons or personal wishes, (3) patients with the objective reasons (such as abundant blood supply around the lesion) who could not complete the biopsy, (4) patients who are participating in other clinical studies, (5) patients with poor compliance who are believed by the researchers to be unable to cooperate for the completion of the examination and follow-up, and (6) women who were pregnant.

Read more

R-EBUS and OCT In this study, all procedures were conducted using a standardized flexible bronchoscopy (Olympus, Japan) featuring an outer diameter of 4.2mm. R-EBUS system (Olympus, Japan) incorporated an ultra-thin radial ultrasonic probe (Olympus UM-S20-17S), which measures merely 1.4mm in diameter. The OCT (Yongshida Medical Technology, Guangdong, China) probe is a cylindrical catheter, 1.7mm in diameter and 150cm in length. Placing the probe through the working channel of bronchoscope for real time dynamic scanning of lesions.

Research Process In this study, the entirety of the procedures was performed by the same respiratory physician with 5 years of experience in respiratory endoscopic diagnosis and treatment, including preoperative evaluation, preparation, lesion localization and biopsy. The respiratory physician had examined the bilateral airways with flexible bronchoscopy after the completion of preoperative anesthesia and found no lesions. The subsequent step involved the precise placement of the OCT probe, guided by prior CT scan results. This stage was critical for marking the lesion, determining its nature (benign or malignant), and, in cases of malignancy, identifying its pathological classification. In instances where the OCT failed to identify any lesion, the R-EBUS was employed to facilitate lesion localization and biopsy. Conversely, when PPLs was detected via OCT, R-EBUS was additionally utilized to corroborate the PPLs localization and to assist in completing the biopsy procedure. For cases where OCT localization failed, R-EBUS would be used. After successful confirmation with R-EBUS, an attempt was made again to insert the OCT probe and completed biopsy. Rapid On-Site Evaluation (ROSE) was employed for the assessment of biopsy specimens. A total of five specimens were collected from each lesion and subjected to ROSE. In scenarios where ROSE provided a definitive diagnosis, no additional biopsies were deemed necessary. Conversely, in instances where ROSE yielded non-definitive results, further biopsy samples were obtained. All biopsy specimens were preserved in 10% formalin, preparing them for detailed histopathological analysis. The ultimate pathological diagnoses were determined based on the reports issued by the pathology department.

In this study, the demographics of all patients were documented, including age, gender, and smoking history. Additionally, detailed clinical parameters, such as the location and size of the lesions, airway grades (ranging from 0 to 24) that the PPLs located, location time of OCT and the number of specimens, were systematically recorded. investigators also conducted extensive follow-up to track histopathological outcomes, whether from surgical biopsies, CT-guided percutaneous transthoracic needle biopsies, or other diagnostic avenues, including chest CT performed two months post-procedure. All the patients were followed up by telephone or outpatient service on the 1st and 3rd day after the procedure, and adverse events were recorded. All individuals underwent general anesthesia and were fitted with a laryngeal mask.

Read the detailed description

See details in"Brief summary"

Conditions
Lung Neoplasm
Being tested
Optical Coherence Tomography
Keywords
Peripheral Pulmonary Lesions
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optical Coherence TomographyDevice

    Also called radial probe endobronchial ultrasound

    Comparing the localization ability of OCT and R-EBUS in Peripheral Pulmonary Lesions and the predictive ability of lung cancer pathological classification

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The diagnostic yield of OCT or R-EBUS-guided TBB in PPLs

    Ability to locate PPLs

    Measured: baseline

Secondary outcomes (2)
  1. The pathological diagnostic value of OCT and R-EBUS

    The ability to distinguish between benign and malignant lesions and pathological classification of malignant lesions by using OCT and R-EBUS

    Measured: baseline

  2. The demographics of all patients

    age(year), gender(male, female), and smoking history(yes or no),the location and size of the lesions, airway grades (ranging from 0 to 24) that the PPLs located, location time(seconds) of OCT and the number of specimens(number=1,2,3...),surgical biopsies, CT-guided percutaneous transthoracic needle biopsies, or other diagnostic avenues, including chest CT performed two months post-procedure

    Measured: baseline and 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2024
  2. Study start1 Mar 2024
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

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
Other
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06419114
Sponsor's protocol ID
SichuanPPHGZ01
Acronym
OCTGTBIPPL
Status last verified
May 2024
First submitted
10 May 2024
Last updated
20 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhou G, Yang Y, Liao Y, Chen L, Yang Y, Zou J. A pilot study of optical coherence tomography-guided transbronchial biopsy in peripheral pulmonary lesions. Expert Rev Med Devices. 2024 Sep;21(9):859-867. doi: 10.1080/17434440.2024.2389235. Epub 2024 Aug 6.

    PubMed 39107968

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Neoplasm, run by Sichuan Provincial 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?

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 20 May 2024. 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 Guanghong Zhou, master (8618302880040, zhough0526@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The diagnostic yield of OCT or R-EBUS-guided TBB in PPLs (time frame: baseline). 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 NCT06419114, 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 20 May 2024.

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