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Mediastinal EBUS Cryobiopsy Study In Sweden
Sponsor: Region Skane
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.
Official title: Mediastinal Endobronchial Ultrasound Bronchoscopy Cryobiopsy Study In Sweden
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2024-04-01
Completion Date
2028-12-31
Last Updated
2025-07-17
Healthy Volunteers
No
Interventions
Mediastinal lymph nodes cryobiopsies
EBUS Mediastinal lymph nodes cryobiopsies
Locations (2)
Respiratory medicine and allergy department, Skåne University Hospital
Lund, Sweden
Norrlands universitetssjukhus
Umeå, Sweden