NCT04727190

Brief Summary

The aim of this study is to investigate the difference of efficacy and safety between transbronchial cryobiopsy (TBCB) and transbronchial forceps biopsy (TBFB) in the diagnosis of lung ground-glass opacity.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2020

Completed
11 months until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

7 months

First QC Date

March 15, 2020

Last Update Submit

January 28, 2021

Conditions

Lung Ground-Glass Opacity

Keywords

Lung Ground-Glass OpacityTransbronchial CryobiopsyForceps BiopsyDiagnosis

Outcome Measures

Primary Outcomes (1)

  • Diagnostic yield

    Diagnostic yield of transbronchial cryobiopsy (TBCB) or transbronchial forceps biopsy (TBFB) for lung ground-glass opacity.

    Up to 6 Months

Secondary Outcomes (1)

  • Tissue size

    Up to 1 months

Other Outcomes (4)

  • Sampling time

    Up to 1 months

  • Number of sampling and effective sampling

    Up to 1 months

  • Quality of specimens

    Up to 6 months

  • +1 more other outcomes

Study Arms (2)

TBCB group

EXPERIMENTAL

Specimens were obtained using 1.1 mm ultrathin cryoprobe with or without guide sheath by bronchoscope.

Procedure: Transbronchial Cryobiopsy

TBFB group

ACTIVE COMPARATOR

Specimens were obtained using 1.5 mm or 1.9 mm biopsy forceps with or without guide sheath by bronchoscope.

Procedure: Transbronchial Forceps Biopsy

Interventions

Transbronchial CryobiopsyPROCEDURE

The eligible patient will be randomized to TBCB group to receive transbronchial cryobiopsy.

TBCB group
Transbronchial Forceps BiopsyPROCEDURE

The eligible patient will be randomized to TBFB group to receive transbronchial forceps biopsy.

TBFB group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged between 18 and 80.
  • CT or other imaging examination suggest a tendency towards malignant GGO (size ≥ 8 mm). The ground glass composition is more than 50%.
  • Thin-slice CT scan with bronchial access or adjacent lesions.
  • Multidisciplinary assessment suggest that bronchopulmonary biopsy is needed to identify the pathological features of GGO.
  • It is suitable for pathological biopsy by transbronchial cryobiopsy or forceps biopsy.
  • Ability to read, understand and sign ICF.

You may not qualify if:

  • Disseminated GGO, suspected of benign or infectious lesions.
  • Preoperative imaging examination showed that the biopsy lesion was adjacent to the middle or large vessels.
  • There are contraindications for bronchoscopy, such as irreparable coagulation dysfunction, severe cardiopulmonary insufficiency.
  • Intolerance or difficulty in cooperating with bronchoscopy, etc.
  • Routine bronchoscopic abnormalities, such as endoscopic lesions, external pressure, mucosal lesions, stenosis, hemorrhage, etc.
  • Vulnerable groups, such as pregnant women, etc.
  • Some other special situations investigator consider subjects are not suitable to participant in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Location

Related Publications (7)

  • Heidinger BH, Anderson KR, Nemec U, Costa DB, Gangadharan SP, VanderLaan PA, Bankier AA. Lung Adenocarcinoma Manifesting as Pure Ground-Glass Nodules: Correlating CT Size, Volume, Density, and Roundness with Histopathologic Invasion and Size. J Thorac Oncol. 2017 Aug;12(8):1288-1298. doi: 10.1016/j.jtho.2017.05.017. Epub 2017 May 30.

    PMID: 28576745BACKGROUND

  • Ussavarungsi K, Kern RM, Roden AC, Ryu JH, Edell ES. Transbronchial Cryobiopsy in Diffuse Parenchymal Lung Disease: Retrospective Analysis of 74 Cases. Chest. 2017 Feb;151(2):400-408. doi: 10.1016/j.chest.2016.09.002. Epub 2016 Sep 19.

    PMID: 27660154BACKGROUND

  • Schuhmann M, Bostanci K, Bugalho A, Warth A, Schnabel PA, Herth FJ, Eberhardt R. Endobronchial ultrasound-guided cryobiopsies in peripheral pulmonary lesions: a feasibility study. Eur Respir J. 2014 Jan;43(1):233-9. doi: 10.1183/09031936.00011313. Epub 2013 Jul 30.

    PMID: 23900983BACKGROUND

  • Imabayashi T, Uchino J, Yoshimura A, Chihara Y, Tamiya N, Kaneko Y, Yamada T, Takayama K. Safety and Usefulness of Cryobiopsy and Stamp Cytology for the Diagnosis of Peripheral Pulmonary Lesions. Cancers (Basel). 2019 Mar 22;11(3):410. doi: 10.3390/cancers11030410.

    PMID: 30909479BACKGROUND

  • Jiang S, Liu X, Chen J, Ma H, Xie F, Sun J. A pilot study of the ultrathin cryoprobe in the diagnosis of peripheral pulmonary ground-glass opacity lesions. Transl Lung Cancer Res. 2020 Oct;9(5):1963-1973. doi: 10.21037/tlcr-20-957.

    PMID: 33209616BACKGROUND

  • Izumo T, Sasada S, Chavez C, Tsuchida T. The diagnostic utility of endobronchial ultrasonography with a guide sheath and tomosynthesis images for ground glass opacity pulmonary lesions. J Thorac Dis. 2013 Dec;5(6):745-50. doi: 10.3978/j.issn.2072-1439.2013.11.30.

    PMID: 24409350BACKGROUND

  • Ikezawa Y, Sukoh N, Shinagawa N, Nakano K, Oizumi S, Nishimura M. Endobronchial ultrasonography with a guide sheath for pure or mixed ground-glass opacity lesions. Respiration. 2014;88(2):137-43. doi: 10.1159/000362885. Epub 2014 Jul 2.

    PMID: 24993187BACKGROUND

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jiayuan Sun, MD, PhD

    Shanghai Chest Hospital

    STUDY DIRECTOR

Central Study Contacts

Jiayuan Sun, MD, PhD

CONTACT

+86-021-22200000xkyyjysun@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Department of Respiratory Endoscopy

Study Record Dates

First Submitted

March 15, 2020

First Posted

January 27, 2021

Study Start

March 1, 2021

Primary Completion

September 30, 2021

Study Completion

December 30, 2021

Last Updated

February 2, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)