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NCT Number: NCT04571476

Diagnostic Value of UTB and TB for PPL

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.

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Key information

Conditions

Peripheral Pulmonary Lesion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Ultrathin bronchoscope

Procedure

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

Other names: UTB

Thin bronchoscope

Procedure

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

Other names: TB

Virtual bronchoscopic navigation combined with endobronchial ultrasound

Procedure

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.

Other names: VBN-EBUS

Guide sheath

Procedure

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

Other names: GS

Primary outcomes

  1. Diagnostic yield

    Time frame: Up to 6 months

    Diagnostic yield of ultrathin and thin bronchoscope for peripheral pulmonary lesions

Secondary outcomes

  1. Total examination time

    Time frame: During the procedure

    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

  2. Duration of finding lesions

    Time frame: During the procedure

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

  3. Feature of lesions

    Time frame: Up to 6 months

    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.

  4. Difference in the bronchus level reached with the bronchoscope

    Time frame: During the procedure

    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

  5. Difference in diagnostic yield

    Time frame: Up to 6 months

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

  6. Complication rate

    Time frame: 1 month

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

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Henan Provincial People's Hospital
  • The First Affiliated Hospital of Guangzhou Medical University
  • West China Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 1, 2020
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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