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NCT06752395Enrolling by invitation

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 · Last updated 3 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Enrolling by invitation
Study type
Interventional
Enrollment
200 (estimated)
First submitted
21 Dec 2024
Start date
1 Nov 2024
Primary completion date
1 Nov 2025
Lead sponsor
Pusan National University Hospital
Diseases
Lung cancer
NCT number
NCT06752395

What you commit to

  • Study type: Interventional
  • Planned participants: 200
  • From 1 Nov 2024 to the primary completion date, 1 Nov 2025
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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 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.
  • Patients with confirmed lung cancer undergoing rebiopsy for genetic testing or other purposes.

Lab values

  • Patients with bleeding disorders (e.g., platelet count \< 100,000/mm³).

Other

  • Pregnant or breastfeeding patients.

Who the study is looking for

  • Age ≥ 18 years
  • Obtained written informed consent
  • Subjects having \<30mm nodule on computed tomography
  • Subjects without contraindication to brochoscopy

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Pusan National University Hospital
Coordinator of this site? Confirm its status
BusanSouth KoreaUnknown status
Yeungnam University Medical Center
Coordinator of this site? Confirm its status
DaeguSouth KoreaUnknown status
Chungnam National University Hospital
Coordinator of this site? Confirm its status
DaejeonSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.