Mediastinal EBUS Cryobiopsy Study In Sweden

Condition(s) studied

Investigational drug(s) / intervention(s)

Mediastinal lymph nodes cryobiopsies: EBUS Mediastinal lymph nodes cryobiopsies

Study 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

Primary outcome measure(s)

• Number of mediastinal cryobiopsies needed per patient to lead to a definite diagnosis. — 2 years
  The result will be presented as the mean value of the number of biopsies needed to analyze for each individual to reach a definite diagnosis.

Trial sites (2)

More Region Skane trials in Sweden

Other trials for the same condition