Mediastinal Endobronchial Ultrasound Bronchoscopy Cryobiopsy Study In Sweden

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Sweden
Respiratory medicine and allergy department, Skåne University Hospital
RECRUITING
Lund
Norrlands universitetssjukhus
RECRUITING
Umeå
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 200
Treatments
All the patients undergo the same procedure
All the patients undergo the same procedure and every patient's own samples are compared to each other.
Sponsors
Leads: Region Skane

This content was sourced from clinicaltrials.gov