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

January 11, 2026 updated by: Li Shiyue, Guangzhou Medical University

Study on the Effectiveness and Safety of Confocal Laser Endomicroscopy Combined With Ultrafine Cryoprobe for Biopsy Diagnosis of Pulmonary Lesions

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510100
        • The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510163

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Diffuse- Conventional Group
The Diffuse-Conventional Group used conventional cryobiopsy for lung lesions.
Other: Conventional cryobiopsy
Patients in the conventional group will underg cryobiopsy for lung lesions.
Experimental: Diffuse- Combined Group
The Diffuse-Combined Group used CLE combined with cryobiopsy for lung lesions
Other: Confocal laser endomicroscopy combined cryobiopsy
Patients in the combined group will undergo CLT combined with cryobiopsy for lung lesions.
Active Comparator: Localized - Convention Group
The Localized-Conventional Group used conventional cryobiopsy for lung lesions.
Other: Conventional cryobiopsy
Patients in the conventional group will underg cryobiopsy for lung lesions.
Experimental: Localized - Combined Group
The Localized-Combined Group used CLE combined with cryobiopsy for lung lesions
Other: Confocal laser endomicroscopy combined cryobiopsy
Patients in the combined group will undergo CLT combined with cryobiopsy for lung lesions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: 7 days after procedure
The Incidence of adverse events = (the number of adverse event / the number of procedures) * 100%
7 days after procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic yield
Time Frame: Immediately after the procedure
The diagnostic yield = (the number of successful diagnoses / the number of completed biopsies) * 100%
Immediately after the procedure
Hole-in-lesion rate
Time Frame: During the procedure
The rate of "hole-in-lesion" = (The number of cases with "hole-in-lesion" / The total number of cases that completed biopsy) * 100% The definition of "Hole-in-lesion": After cryobiopsy, a CBCT scan is performed, and the CBCT image shows the presence of a cavity within the lesion.
During the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 11, 2026

First Submitted That Met QC Criteria

January 11, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLE-Cryo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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