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Peripheral Pulmonary LesionNCT04571476

Diagnostic Value of UTB and TB for PPL

A study testing Ultrathin bronchoscope, Thin bronchoscope and Virtual bronchoscopic navigation combined with endobronchial ultrasound in people with Peripheral Pulmonary Lesion, run by Shanghai Chest Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to evaluate the diagnostic value and safety of ultrathin and thin bronchoscope (UTB and TB) for peripheral pulmonary lesions (PPLs) without X-ray fluoroscopy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Pulmonary Lesion
What is being tested?
Ultrathin bronchoscope, Thin bronchoscope and Virtual bronchoscopic navigation combined with endobronchial ultrasound
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
578 participants
Where
1 siteChina
Study dates
8 Mar 2021to 31 Jul 2022
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients older than 18 years old.
  • Chest imaging shows the presence of peripheral pulmonary lesions (defined as those lesions that are surrounded by pulmonary parenchyma and located below the segmental bronchus) that need to be confirmed by pathology. The length diameter of the lesion is no less than 8 mm and no more than 5 cm.
  • Patients without contraindications of bronchoscopy.
  • Patients have good medical adherence and signed informed consent.

Who cannot join

  • Peripheral pulmonary lesion is pure ground-glass opacity.
  • Absence of bronchus leading to or adjacent to the lesion on thin-slice chest CT.
  • Visible lumen lesions in segment and above segment bronchus during bronchoscopy (evidence of endobronchial lesion, extrinsic compression, submucosal tumor, narrowing, inflammation or bleeding of the bronchus).
  • Diffuse pulmonary lesions.
  • The investigators believe that patient has other conditions that are not suitable for the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030

Other trials in China

About this study

Official title: Diagnostic Value of Ultrathin and Thin Bronchoscope for Peripheral Pulmonary Lesions: A Prospective Randomized Controlled Multicenter Study

The purpose of the study is to evaluate the diagnostic value and safety of ultrathin and thin bronchoscope (UTB and TB) for peripheral pulmonary lesions (PPLs) without X-ray fluoroscopy.

Read the detailed description

The study aims to evaluate the diagnostic value and safety of ultrathin and thin bronchoscope (UTB and TB) with the guidance of virtual bronchoscopic navigation (VBN) combined with endobronchial ultrasound (EBUS) for peripheral pulmonary lesions (PPLs) without X-ray fluoroscopy. The study is designed as a prospective, multicenter, randomized controlled clinical trial. The participating centers are The First Affiliated Hospital of Guangzhou Medical University, Cancer Hospital Chinese Academy of Medical Sciences, West China Hospital, Sichuan University, and Henan Provincial People's Hospital. Patients are divided into three groups: UTB-VBN-EBUS group, TB-VBN-EBUS-GS group and TB-VBN-EBUS-non-GS group. Each subject will be randomized to each group. The study is expected to enroll a total of 577 patients with 193, 192 and 192 in UTB-VBN-EBUS group, TB-VBN-EBUS-GS group and TB-VBN-EBUS-non-GS group, respectively.

Being tested
Ultrathin bronchoscope, Thin bronchoscope, Virtual bronchoscopic navigation combined with endobronchial ultrasound, Guide sheath
Keywords
Ultrathin bronchoscope, Thin bronchoscope, Peripheral pulmonary lesion

What participants receive

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

  • Ultrathin bronchoscopeProcedure or surgery

    Also called UTB

    Ultrathin bronchoscope (UTB) with an outer diameter no more than 3.0-mm and a 1.7-mm working channel.

  • Thin bronchoscopeProcedure or surgery

    Also called TB

    Thin bronchoscope with a 4.0-mm outer diameter and a 2.0-mm working channel.

  • Virtual bronchoscopic navigation combined with endobronchial ultrasoundProcedure or surgery

    Also called VBN-EBUS

    VBN can create a path to the target lesion automatically when the lesion is depicted in this software.VBN combined with EBUS can improve the diagnostic yield of PPL and shorten the examination time, which has become the standard method for the diagnosis of PPL.

  • Guide sheathProcedure or surgery

    Also called GS

    GS is a cannula with the thinnest outer diameter of 1.95 mm.

Study groups in NCT04571476
Study groupRoleWhat they receive
UTB-VBN-EBUS groupExperimentalUltrathin bronchoscope with a 3.0-mm outer diameter and a 1.7-mm working channel was used in this group. Specimens were obtained using 1.5-mm biopsy forceps and 1.4-mm cytology brush with the guidance of VBN and EBUS.
Receives: Procedure: Ultrathin bronchoscope; Procedure: Virtual bronchoscopic navigation combined with endobronchial ultrasound
TB-VBN-EBUS-GS groupActive comparatorThin bronchoscope with a 4.0-mm outer diameter and a 2.0-mm working channel was used in this group. Specimens were obtained using 1.5-mm biopsy forceps and 1.4-mm cytology brush with the guidance of VBN-EBUS and a 1.95-mm outer diameter guide sheath.
Receives: Procedure: Thin bronchoscope; Procedure: Virtual bronchoscopic navigation combined with endobronchial ultrasound; Procedure: Guide sheath
TB-VBN-EBUS-non-GS groupActive comparatorThin bronchoscope with a 4.0-mm outer diameter and a 2.0-mm working channel was used in this group. Specimens were obtained using conventional biopsy forceps and cytology brush with the guidance of VBN and EBUS, but without guide sheath.
Receives: Procedure: Thin bronchoscope; Procedure: Virtual bronchoscopic navigation combined with endobronchial ultrasound

What is being measured

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

  1. Diagnostic yield

    Diagnostic yield of ultrathin and thin bronchoscope for peripheral pulmonary lesions

    Measured: Up to 6 months

Secondary outcomes (6)

  1. Total examination time

    Total examination time is defined from the time that the bronchoscope is inserted beyond the glottis, until the bronchoscope has been removed from the glottis after examination

    Measured: During the procedure

  2. Duration of finding lesions

    Duration of finding lesions defined from insertion of ultrasound probe to withdrawal of ultrasound probe

    Measured: During the procedure

  3. Feature of lesions

    The feature of peripheral pulmonary lesions affecting the diagnostic yield includes the nature, size, location, the position of the ultrasound probe relative to the lesions etc.

    Measured: Up to 6 months

  4. Difference in the bronchus level reached with the bronchoscope

    Level: Bronchus is level 0, leaf bronchus is level 1, segment bronchus is level 2, sub-segment bronchus is level 3, and so on, such as: LB3a is level 3

    Measured: During the procedure

  5. Difference in diagnostic yield

    Difference in diagnostic yield between thin bronchoscope with guide sheath combined small biopsy forceps and without guide sheath combined with conventional biopsy forceps.

    Measured: Up to 6 months

  6. Complication rate

    The complications refer to the total of serious adverse events related to the procedure during or within 1 month after the operation.

    Measured: 1 month

Timeline

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

  1. First posted1 Oct 2020
  2. Study start8 Mar 2021
  3. Primary completion7 Jan 2022
  4. Study completion31 Jul 2022

Resources

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
578 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04571476
Sponsor's protocol ID
SHCHE202002
Status last verified
Sep 2023
First submitted
26 Sep 2020
Last updated
6 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
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 15364779

  • Steinfort 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

  • Yoshikawa 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 17565021

  • Asano F, Ishida T, Shinagawa N, Sukoh N, Anzai M, Kanazawa K, Tsuzuku A, Morita S. Virtual bronchoscopic navigation without X-ray fluoroscopy to diagnose peripheral pulmonary lesions: a randomized trial. BMC Pulm Med. 2017 Dec 11;17(1):184. doi: 10.1186/s12890-017-0531-2.

    PubMed 29228929

  • Oki M, Saka H, Asano F, Kitagawa C, Kogure Y, Tsuzuku A, Ando M. Use of an Ultrathin vs Thin Bronchoscope for Peripheral Pulmonary Lesions: A Randomized Trial. Chest. 2019 Nov;156(5):954-964. doi: 10.1016/j.chest.2019.06.038. Epub 2019 Jul 26.

    PubMed 31356810

  • Oki M, Saka H, Ando M, Asano F, Kurimoto N, Morita K, Kitagawa C, Kogure Y, Miyazawa T. Ultrathin Bronchoscopy with Multimodal Devices for Peripheral Pulmonary Lesions. A Randomized Trial. Am J Respir Crit Care Med. 2015 Aug 15;192(4):468-76. doi: 10.1164/rccm.201502-0205OC.

    PubMed 26039792

  • Asano F, Shinagawa N, Ishida T, Shindoh J, Anzai M, Tsuzuku A, Oizumi S, Morita S. Virtual bronchoscopic navigation combined with ultrathin bronchoscopy. A randomized clinical trial. Am J Respir Crit Care Med. 2013 Aug 1;188(3):327-33. doi: 10.1164/rccm.201211-2104OC.

    PubMed 23600452

  • Feng X, Zhang Q, Luo F, Zhang X, Zhang L, Xie F, Sun J, Li S. Study design for a multicenter, randomized controlled trial evaluating the diagnostic value of ultrathin bronchoscope compared to thin bronchoscope without fluoroscopy for peripheral pulmonary lesions. J Thorac Dis. 2022 May;14(5):1663-1673. doi: 10.21037/jtd-22-20.

    PubMed 35693609

Questions about this trial

What is this clinical trial studying?

A study testing Ultrathin bronchoscope, Thin bronchoscope and Virtual bronchoscopic navigation combined with endobronchial ultrasound in people with Peripheral Pulmonary Lesion, 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 4 inclusion and 5 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 6 Sep 2023. 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?

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?

Diagnostic yield (time frame: Up to 6 months). 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 NCT04571476, which also lists 8 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 6 Sep 2023.

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