Tests a cryobiopsy sampling method for mediastinal lymph nodes in Sweden
Tests a lymph node sampling procedure in adults with chest lymph node swelling.
Plain-language title generated from the registry record
Registry title: Mediastinal EBUS Cryobiopsy Study In Sweden
Key facts
- Where
- Lund and Umeå, SwedenSee the 2 sites
Where in Sweden
- Respiratory medicine and allergy department, Skåne University HospitalLund, SwedenTaking people
- Norrlands universitetssjukhusUmeå, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Region Skane
- Trial code
- NCT06347939
- Record updated
- 17 July 2025
- Original description
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).Read full original descriptionShow less
Mediastinal Endobronchial Ultrasound Bronchoscopy Cryobiopsy Study In Sweden
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.
Inclusion: 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: Myocardial infarction in the last six weeks prior to participating in the study; Respiratory failure and inadequate blood oxygenation despite oxygen supply; High bleeding risk; Hemodynamically instable patient; Life threatening arrythmia; Tracheal obstruction of high grade; Patient not willing to participate in the study; Patient not speaking swedish and needing translator during the procedure.