Mediastinal EBUS Cryobiopsy Study In Sweden

Recruiting now

Conditions studied: Mediastinal Lymphadenopathy, Lung Cancer, Sarcoidosis, Lymphoma, Tuberculosis

In brief

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.

Key facts

Study ID

NCT06347939

Run by

Region Skane

People needed

200

Starts

2024-04-01

Expected to finish

2028-12-31

Last updated by the study team

2025-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Mediastinal lymphadenopathy with a diameter greater than 1 cm.
• Indication for assessment and sampling according to clinical praxis
• Age > 18 years
• Patients consent to participate in the study.

You may not qualify if…

• Hemodynamically instable patient
• Myocardial infarction in the last six weeks prior to participating in the study.
• Life threatening arrythmia
• Respiratory failure and inadequate blood oxygenation despite oxygen supply.
• Tracheal obstruction of high grade.
• High bleeding risk
• Patient not willing to participate in the study
• Patient not speaking swedish and needing translator during the procedure

Where it is running

• Respiratory medicine and allergy department, Skåne University Hospital — Lund, Sweden (enrolling)
• Norrlands universitetssjukhus — Umeå, Sweden (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.