Health TrialsbyHealthPanel

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

ConditionsPulmonary LesionLung Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangzhou Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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. -

Disqualifiers

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.;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Confocal laser endomicroscopy combined cryobiopsy

    Other intervention

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

  • Conventional cryobiopsy

    Other intervention

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

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: Diffuse- Conventional GroupActive comparator 1 intervention
Group B: Diffuse- Combined GroupExperimental treatment 1 intervention
Group C: Localized - Convention GroupActive comparator 1 intervention
Group D: Localized - Combined GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of adverse events

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

Time frame
7 days after procedure

Secondary outcomes

1

Diagnostic yield

The diagnostic yield = (the number of successful diagnoses / the number of completed biopsies) \* 100%

Time frame
Immediately after the procedure
2

Hole-in-lesion rate

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.

Time frame
During the procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangzhou Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: