Diagnosis of Peripheral Lung Nodules Using Cryobiopsy

NCT04885595 | Completed DMC

• 1 other identifier: 2021-00323
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Lung; Node

Keywords

Cryobiopsy

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield

  The diagnostic yield of the malign lesions that we were able to visualise with EBUS in percentage

  up to 1 month

Secondary Outcomes (6)

• Size of harvested tissue in millimeter

  up to 1 month

• Size of malign tissue in millimeter

  up to 1 month

• Occurrence of bleeding events

  up to 1 month

• Size of artifact-free alvoelar space in percentage

  up to 1 month

• Radial endobronchial utrasound probe orientation (excentric, concentric, adjacent)

  1 day

Study Arms (2)

Forceps-Cryo 1.1 mm

ACTIVE COMPARATOR

Forceps biopsy following cryobiopsy with a 1.1mm cryoprobe are obtained within the same session

Procedure: Forceps biopsy and cryobiopsy

Forceps-Cryo 1.7 mm

ACTIVE COMPARATOR

Forceps biopsy following cryobiopsy with a 1.7mm cryoprobe are obtained within the same session

Procedure: Forceps biopsy and cryobiopsy

Interventions

Forceps biopsy and cryobiopsy PROCEDURE

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.

Forceps-Cryo 1.1 mm; Forceps-Cryo 1.7 mm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Solitary pulmonary nodule with indication of bronchoscopic diagnostic approach
• Age between 18 and 90 years
• Written informed consent after participant's information

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University hospital Zurich

Zurich, 8091, Switzerland

Location

Study Officials

• Carolin Steinack, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2021
• First Posted: May 13, 2021
• Study Start: April 1, 2021
• Primary Completion: April 15, 2023
• Study Completion: May 30, 2023
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)