Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04885595
Other study ID # 2021-00323
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date December 30, 2022

Study information

Verified date July 2022
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Since the traditional radial endobronchial ultrasound guided biopsy technique of solitary pulmonary nodules using the forceps has several shortcomings, the purpose of this study is to investigate a new biopsy technique using the transbronchial cryobrobe


Description:

This is a prospective randomized trial to assess diagnostic accuracy and safety of cryobiopsy using two different outer diameters. Included patients are 1:1 randomized to receive forceps biopsy following cryobiopsy with a 1.1mm or 1.7mm cryoprobe.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date December 30, 2022
Est. primary completion date April 7, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Solitary pulmonary nodule with indication of bronchoscopic diagnostic approach - Age between 18 and 90 years - Written informed consent after participant's information Exclusion Criteria: - Age < 18 and > 90 years - Lacking ability to form an informed consent (including impaired judgement, communi-cation barriers) - Contraindication against bronchoscopy (e.g. co-morbidities) - INR > 2 or Thrombocytes < 50000 - Double antiplatelet drugs (e.g. ASS and Clopidogrel) within 7 days before biopsy - Anticoagulation with NOAK within 48 hours before biopsy - Moderate or severe pulmonary hypertension (mPAP > 30 mmHg, RV/RA >30 mmHg) - Tumors suspicious of endobronchial growth

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Forceps biopsy and cryobiopsy
Once the nodule is visualized by radial EBUS, the position of the probe in relation to the lesion is noted. Routinely, forceps biopsy and cryobiopsy are used serially in each patient within the same session.

Locations

Country Name City State
Switzerland University hospital Zurich Zurich

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic yield The diagnostic yield of the malign lesions that we were able to visualise with EBUS in percentage up to 1 month
Secondary Size of harvested tissue in millimeter The biopsies are assessed for total size in millimeter up to 1 month
Secondary Size of malign tissue in millimeter The biopsies are assessed for size of malign tissue in milimeter up to 1 month
Secondary Occurrence of bleeding events Occurrence of bleeding events up to 1 month
Secondary Size of artifact-free alvoelar space in percentage Size of artifact-free alvoelar space in percentage up to 1 month
Secondary Radial endobronchial utrasound probe orientation (excentric, concentric, adjacent) Lesion orientation with regards of the radial endobronchial ultrasound probe 1 day
Secondary Occurence of pneumothorax Detection with X-ray up to 1 month
See also
  Status Clinical Trial Phase
Recruiting NCT04745962 - Thin EBUS Pilot Study
Completed NCT06033729 - Remifentanil Target Controlled Infusion Versus Standard of Care for Conscious Sedation During EBUS-TBNA N/A
Withdrawn NCT05738031 - Investigating Incidental Pulmonary Nodules in Underserved Communities
Not yet recruiting NCT05716815 - Prospective rAndomized sTudy efficaCy tHree-dimensional rEconstructions Segmentectomy N/A
Completed NCT03727425 - Robotic Bronchoscopy for Peripheral Pulmonary Lesions N/A
Completed NCT04758403 - CBCT-Guided Navigational Bronchoscopy For Lung Nodules N/A
Recruiting NCT04792632 - Clinical Performance Evaluation of Veye Lung Nodules
Recruiting NCT05801406 - From Benchmark to Surgical Activity: the Role of Endobronchial Fiducial Markers for Ground Glass Lung Nodules Resection.
Recruiting NCT05426135 - Artificial Intelligence System for Assessment of Tumor Risk and Diagnosis and Treatment
Completed NCT04217655 - Low-dose Computed Tomography-guided Core Needle Biopsy for Lung Nodules N/A
Recruiting NCT05526573 - Diagnostic Yeld of Ultrathin Bronchoscopy in Peripheral Pulmonary Lesions
Recruiting NCT04005677 - The Early Diagnosis of Pulmonary Nodule Based on Multi-dimension Messages
Active, not recruiting NCT04734145 - Using e-Nose Technology to Identify Early Lung Cancer
Enrolling by invitation NCT05183945 - Preoperative Computed Tomography-guided Localization for Lung Nodules: Localization Needle Versus Coil N/A
Recruiting NCT05665504 - Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer
Not yet recruiting NCT04740606 - Airway Navigation Database Asia for Diagnosis of Peripheral Pulmonary Nodules
Recruiting NCT05306912 - Molecular Analysis of Endoscopic Cytology Samples Supernatant in Pulmonary Nodules N/A
Recruiting NCT05463796 - InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer