Study on the Effectiveness and Safety of CLE Combined With Cryobiopsy for Diagnosis of Pulmonary Lesions

NCT07352176 | Not Yet Recruiting

• 1 other identifier: CLE-Cryo
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Forty subjects meeting the inclusion and exclusion criteria were recruited at a single center and signed informed consent forms. Among them, 20 patients in the diffuse group and 20 patients in the localized group were randomly assigned to the conventional radial endobronchial ultrasound combined with cryobiopsy group (conventional group) and the confocal laser endomicroscopy combined with cryobiopsy group (combined group). During the operation, the operator manipulated the bronchoscope to reach the lesion. After confirming the arrival at the lesion using radial endobronchial ultrasound/confocal laser endomicroscopy, cryobiopsy was performed, and the size of the sample was recorded. CBCT scanning was conducted after cryobiopsy. If there was no hole-in-lesion image, cryobiopsy was performed again under CBCT guidance. CBCT scanning was performed after biopsy to determine whether there were any adverse events.

Conditions

Pulmonary Lesion; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  The Incidence of adverse events = (the number of adverse event / the number of procedures) \* 100%

  7 days after procedure

Secondary Outcomes (2)

• Diagnostic yield

  Immediately after the procedure

• Hole-in-lesion rate

  During the procedure

Study Arms (4)

Diffuse- Conventional Group

ACTIVE COMPARATOR

The Diffuse-Conventional Group used conventional cryobiopsy for lung lesions.

Other: Conventional cryobiopsy

Diffuse- Combined Group

EXPERIMENTAL

The Diffuse-Combined Group used CLE combined with cryobiopsy for lung lesions

Other: Confocal laser endomicroscopy combined cryobiopsy

Localized - Convention Group

ACTIVE COMPARATOR

The Localized-Conventional Group used conventional cryobiopsy for lung lesions.

Other: Conventional cryobiopsy

Localized - Combined Group

EXPERIMENTAL

The Localized-Combined Group used CLE combined with cryobiopsy for lung lesions

Other: Confocal laser endomicroscopy combined cryobiopsy

Interventions

Conventional cryobiopsy OTHER

Patients in the conventional group will underg cryobiopsy for lung lesions.

Diffuse- Conventional Group; Localized - Convention Group

Confocal laser endomicroscopy combined cryobiopsy OTHER

Patients in the combined group will undergo CLT combined with cryobiopsy for lung lesions.

Diffuse- Combined Group; Localized - Combined Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years old with lung lesions indicated by chest CT;
• Preoperative CT indicates that the lung lesion to be biopsied has a bronchus leading to it;
• Able to understand and voluntarily sign the written informed consent form. -

You may not qualify if:

• Patients with contraindications to anesthesia or bronchoscopy;
• Patients with uncorrectable coagulation disorders;
• Patients who cannot discontinue therapeutic anticoagulants within an appropriate time interval before surgery;
• Patients with severe liver or kidney dysfunction, mental illness, etc.;
• Pregnant or lactating patients;
• Patients without a clear histological or clinical diagnosis;
• Subjects deemed unsuitable for participation in this study by the investigator.

Sponsors & Collaborators

• Guangzhou Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510163

Guangzhou, Guangdong, 510100, China

Location

Related Publications (3)

• Kramer T, Wijmans L, de Bruin M, van Leeuwen T, Radonic T, Bonta P, Annema JT. Bronchoscopic needle-based confocal laser endomicroscopy (nCLE) as a real-time detection tool for peripheral lung cancer. Thorax. 2022 Apr;77(4):370-377. doi: 10.1136/thoraxjnl-2021-216885. Epub 2021 Jun 25.

  PMID: 34172559 BACKGROUND

• Wellikoff AS, Holladay RC, Downie GH, Chaudoir CS, Brandi L, Turbat-Herrera EA. Comparison of in vivo probe-based confocal laser endomicroscopy with histopathology in lung cancer: A move toward optical biopsy. Respirology. 2015 Aug;20(6):967-74. doi: 10.1111/resp.12578. Epub 2015 Jun 19.

  PMID: 26094505 BACKGROUND

• Sorokina A, Danilevskaya O, Averyanov A, Zabozlaev F, Sazonov D, Yarmus L, Lee HJ. Comparative study of ex vivo probe-based confocal laser endomicroscopy and light microscopy in lung cancer diagnostics. Respirology. 2014 Aug;19(6):907-13. doi: 10.1111/resp.12326. Epub 2014 Jun 9.

  PMID: 24909555 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

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: professor

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: January 20, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

CN (1)