Clinical trial NCT06752395: Cryobiopsy Vs. Forceps Biopsy for Peripheral Pulmonary Lesions
Official title: Cryobiopsy-centered Versus Forceps Biopsy-centered Sampling for the Diagnosis of Peripheral Pulmonary Lesions - a Multicenter Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Lung Cancer (NSCLC)
Keywords: Bronchoscpy
Cryobiopsy
Forceps biopsy
Lung cancer
Radial probe EBUS
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
Collaborators: name: Erbe-med
First posted: 2024-12-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: This is a multi center, clinical trial evaluating the diagnostic yields of cryobiopsy and forceps biopsy methods used for the biopsy of peripheral lung nodules. In the cryobiopsy group, cryobiopsy is the primary method, with forceps biopsy used as an auxiliary technique, while in the forceps biopsy group, forceps biopsy is the primary method, with cryobiopsy as the auxiliary technique. The study also investigates the complementary relationship between these biopsy methods and evaluates differences in diagnostic rates based on the sequence of the procedures.

Eligibility criteria: 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.

Primary outcomes:
measure: The overall cumulative diagnostic yield
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Diagnosis Rate According to Lesion Size
timeFrame: through study completion, an average of 1 year
measure: Diagnosis Rate According to Malignant and Benign Disease Classification
timeFrame: through study completion, an average of 1 year
measure: Diagnosis Rate According to Bronchus Sign
timeFrame: through study completion, an average of 1 year
measure: Diagnosis Rate According to Image Classification Detected by Radial Bronchial Endoscopic Ultrasound (RP-EBUS)
timeFrame: through study completion, an average of 1 year
measure: Complication Rate
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
Study officials:
References: