The Efficacy and Safety of TBCB vs TBFB in Diagnosis of GGO

The Efficacy and Safety of Transbronchial Cryobiopsy vs Forceps Biopsy in the Diagnosis of Lung Ground-glass Opacity: A Prospective, Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Lung Ground-Glass Opacity
• Intervention / Treatment: Procedure: Transbronchial Cryobiopsy; Procedure: Transbronchial Forceps Biopsy

Detailed Description

The conventional biopsy method for lung ground-glass opacity (GGO) diagnosis is to use disposable guided sheath (including biopsy forceps and cell brushes) which have some limitations, such as big physical damage, small biopsy tissue, etc. Cryobiospy is a new technique for biopsy developed in recent years which has many advantages over conventional biopsy, such as larger tissue, higher diagnosis yield, less complication, etc. The investigators will explore the efficacy and safety of cryobiospy vs. biopsy forceps in GGO diagnosis. The study is designed as a prospective, randomized controlled trial, 184 patients will be expected to enroll in the study and receive EBUS examination before biopsy to check whether the GGO lesions exist or not. This is a parallel-control study that patients with GGO lesions will be randomized to either TBCB group or TBFB group for biopsy. The primary aim is to compare the diagnostic yields of the two biopsy techniques. The secondary endpoint is to assess the tissue size, sampling time, number of sampling and the quality of specimen.

• Study Type: Interventional
• Enrollment (Anticipated): 184
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai Chest Hospital
      • Contact: Jiayuan Sun, MD,PhD; Phone Number: 1511 +86-021-22200000; Email: xkyyjysun@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TBCB group; Specimens were obtained using 1.1 mm ultrathin cryoprobe with or without guide sheath by bronchoscope.	Procedure: Transbronchial Cryobiopsy; The eligible patient will be randomized to TBCB group to receive transbronchial cryobiopsy.
ACTIVE_COMPARATOR: TBFB group; Specimens were obtained using 1.5 mm or 1.9 mm biopsy forceps with or without guide sheath by bronchoscope.	Procedure: Transbronchial Forceps Biopsy; The eligible patient will be randomized to TBFB group to receive transbronchial forceps biopsy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic yield	Diagnostic yield of transbronchial cryobiopsy (TBCB) or transbronchial forceps biopsy (TBFB) for lung ground-glass opacity.	Up to 6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tissue size	The maximum diameter measured by the biopsy tissue.	Up to 1 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sampling time	The time spent in sampling the lesions begins with the insertion of biopsy tools into the bronchoscope work channel, and ends with the insertion of all biopsy specimens for the target lesion into the specimen bottle.	Up to 1 months
Number of sampling and effective sampling	The operation for biopsy purposes is taken as one sampling, whether the sample is obtained or not, and if the sample is obtained, record as effective sampling.	Up to 1 months
Quality of specimens	On the premise that other sample processing processes are fixed, different sampling methods will have different effects on the samples. To obtain abnormal lung tissues as eligible samples, the integrity of tissue morphology and structure preservation is an important factor in evaluating the quality of tissue samples.	Up to 6 months
Adverse events	To evaluate the bleeding in the biopsy site mainly, which is one of the main complications of bronchoscopy biopsy. Adverse events shall be judged in accordance with relevant regulations, and serious adverse events shall be recorded and reported in accordance with regulations.	Up to 1 months

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital
• Collaborators: First Affiliated Hospital of Chongqing Medical University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2021
• Primary Completion (ANTICIPATED): September 30, 2021
• Study Completion (ANTICIPATED): December 30, 2021

Study Registration Dates

• First Submitted: March 15, 2020
• First Submitted That Met QC Criteria: January 24, 2021
• First Posted (ACTUAL): January 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Diagnosis; Transbronchial Cryobiopsy; Lung Ground-Glass Opacity; Forceps Biopsy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: SHCHE201904

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No