Clinical trial · Interventional
Cryobiopsy Vs. Forceps Biopsy for Peripheral Pulmonary Lesions
Cryobiopsy-centered Versus Forceps Biopsy-centered Sampling for the Diagnosis of Peripheral Pulmonary Lesions - a Multicenter Prospective Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This multicenter clinical trial evaluates the diagnostic yields of cryobiopsy and forceps biopsy for peripheral lung nodules. In the cryobiopsy group, cryobiopsy is the primary method, supplemented by forceps biopsy. Conversely, in the forceps biopsy group, forceps biopsy is the primary method, supplemented by cryobiopsy. The study also explores the complementary relationship between the two methods and examines differences in diagnostic rates based on the order in which the procedures are performed.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer (NSCLC) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transbronchial lung biopsy with radial probe endobronchial ultrasound (Cryobiopsy centered) | Diagnostic Test | — | UNRESOLVED |
| Transbronchial lung biopsy with radial probe endobronchial ultrasound (Forceps biopsy centered) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cryobiopsy
- description
- Cryobiopsy Group (Primary: Cryobiopsy, Auxiliary: Forceps Biopsy) In this group, cryobiopsy is performed as the primary biopsy method for sampling peripheral lung nodules. After the cryobiopsy is completed, forceps biopsy is conducted as an auxiliary method to obtain additional tissue samples.
- interventionNames
- Diagnostic Test: Transbronchial lung biopsy with radial probe endobronchial ultrasound (Cryobiopsy centered)
- type
- EXPERIMENTAL
- label
- Forceps biopsy
- description
- Forceps Biopsy Group (Primary: Forceps Biopsy, Auxiliary: Cryobiopsy) In this group, forceps biopsy is performed as the primary biopsy method for sampling peripheral lung nodules. Following the forceps biopsy, cryobiopsy is conducted as an auxiliary method to obtain additional tissue samples.
- interventionNames
- Diagnostic Test: Transbronchial lung biopsy with radial probe endobronchial ultrasound (Forceps biopsy centered)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Obtained written informed consent * Subjects having \<30mm nodule on computed tomography * Subjects without contraindication to brochoscopy Exclusion Criteria: * Patients with central lesions that can be visually confirmed by bronchoscopy or those with suspicious findings of cancer metastasis in the mediastinal lymph nodes, who do not require radial bronchial endoscopic ultrasound (RP-EBUS). * Patients who cannot discontinue medications that increase bleeding risk, such as antiplatelet agents or anticoagulants. * Patients with bleeding disorders (e.g., platelet count \< 100,000/mm³). * Patients with severe comorbidities (e.g., serious respiratory or cardiovascular diseases) that make bronchoscopy unsafe. * Patients with hypersensitivity or allergies to drugs commonly used in endoscopic procedures, including lidocaine, midazolam, fentanyl, or flumazenil. * Pregnant or breastfeeding patients. * Patients with confirmed lung cancer undergoing rebiopsy for genetic testing or other purposes.
References
Publications (0)
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