RecruitingNCT06347939

Mediastinal EBUS Cryobiopsy Study In Sweden

Mediastinal Endobronchial Ultrasound Bronchoscopy Cryobiopsy Study In Sweden


Sponsor

Region Skane

Enrollment

200 participants

Start Date

Apr 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

This study is a prospective observational non-randomized clinical trial where all the participitants undergo the same procedure and every participitant's samples are compared to each other. The investigators conduct EBUS TBNA and EBUS TBMCB on all the study participants.The cryobiopsy samples are numbered to evaluate the number of biopsies needed to reach a definite diagnosis and to assess the added value of every sample taken from the same participitant. Every participitant's own samples are compared to each other and added value of EBUS TBMCB is defined as the difference in diagnostic yield between the EBUS TBNA alone and the combination of EBUS TBNA with EBUS TBMCB. Diagnostic yield is defined as the efficacy of the investigation module in reaching a definite diagnosis (percentage of cases with a definite diagnosis). Follow up four weeks after the procedure to assess the risk for postoperative complications.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two methods of taking tissue samples from enlarged lymph nodes in the chest (mediastinum): standard needle biopsy versus a newer technique called cryobiopsy (which uses freezing to collect a larger, better-quality sample). The goal is to determine if cryobiopsy provides more useful diagnostic information. **You may be eligible if...** - You are over 18 years old - You have enlarged lymph nodes in your chest that are larger than 1 cm and need to be sampled to find out why - You are already scheduled for a bronchoscopy (a scope procedure into the airways) to evaluate the lymph nodes as part of your clinical care - You are willing to participate and can speak Swedish **You may NOT be eligible if...** - You are in unstable condition (such as heart failure, recent heart attack, life-threatening arrhythmia, severe breathing difficulty, or blockage of the windpipe) - You have a high risk of bleeding - You do not speak Swedish and require a translator during the procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTMediastinal lymph nodes cryobiopsies

EBUS Mediastinal lymph nodes cryobiopsies


Locations(2)

Respiratory medicine and allergy department, Skåne University Hospital

Lund, Sweden

Norrlands universitetssjukhus

Umeå, Sweden

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06347939


Related Trials