Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
NCT06921681

Ultrasound-guided Cryobiopsy of Mediastinal/Hilar Lymph Nodes

Led by University of Zurich · Updated on 2025-04-10

136

Participants Needed

1

Research Sites

251 weeks

Total Duration

On this page

Sponsors

U

University of Zurich

Lead Sponsor

A

Aarau Cantonal Hospital (KSA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

EBUS-guided cryobiopsy of mediastinal and hilar lymph nodes has shown to be a useful diagnostic tool to obtain tissue for histological analysis and further targeted therapies in lung malignancies. Due to the large size and better quality of the tissue samples, a higher diagnostic yield than with transbronchial needle aspiration (TBNA) can be expected, especially in non-solid tumors. In previous studies different biopsy protocols were used. The freezing time of cryoprobe (which defines the sample sizes) ranged from 3 to 7 s and the number of biopsies was between 1 and 4 samples. It is therefore unclear what freezing times and biopsy frequency are required to obtain the best histological information.

CONDITIONS

Official Title

Ultrasound-guided Cryobiopsy of Mediastinal/Hilar Lymph Nodes

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least one mediastinal lesion or hilar lymph node 1 cm or longer in the short axis requiring diagnostic bronchoscopy
  • Age between 18 and 90 years
  • Written informed consent after participant's information
Not Eligible

You will not qualify if you...

  • Age less than 18 or greater than 90 years
  • Unable to provide informed consent (including impaired judgment or communication barriers)
  • Contraindication against bronchoscopy (e.g., co-morbidities)
  • Mediastinal abscess or cyst
  • Abnormal blood supply to the lesion seen by EBUS bronchoscope
  • INR greater than 1.5 or platelet count less than 100 G/l
  • Use of clopidogrel or other new antiplatelet drugs within 7 days before biopsy (salicylic acid alone allowed)
  • Use of anticoagulation with NOAC within 48 hours before biopsy
  • Presence of pulmonary lesions suspicious for lung carcinoma

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Jürgen Hetzel

Basel, Switzerland

Actively Recruiting

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Research Team

C

Carolin Steinack

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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