Mediastinal EBUS Cryobiopsy Study In Sweden
Recruiting · NCT06347939 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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
2 locations listed.
- Respiratory medicine and allergy department, Skåne University Hospital - Lund, Sweden
- Norrlands universitetssjukhus - Umeå, Sweden