RecruitingNCT06347939

Mediastinal EBUS Cryobiopsy Study In Sweden

Mediastinal Endobronchial Ultrasound Bronchoscopy Cryobiopsy Study In Sweden


Sponsor

Region Skane

Enrollment

200 participants

Start Date

Apr 1, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria8

  • 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

Interventions

DIAGNOSTIC_TESTMediastinal lymph nodes cryobiopsies

EBUS Mediastinal lymph nodes cryobiopsies


Locations(2)

Respiratory medicine and allergy department, Skåne University Hospital

Lund, Sweden

Norrlands universitetssjukhus

Umeå, Sweden

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NCT06347939


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