Clinical trial · Observational
Mediastinal EBUS Cryobiopsy Study In Sweden
Mediastinal Endobronchial Ultrasound Bronchoscopy Cryobiopsy Study In Sweden
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Mediastinal Lymphadenopathy | — | UNRESOLVED | — |
| Sarcoidosis | — | UNRESOLVED | — |
| Tuberculosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mediastinal lymph nodes cryobiopsies | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- All the patients undergo the same procedure
- description
- All the patients undergo the same procedure and every patient's own samples are compared to each other.
- interventionNames
- Diagnostic Test: Mediastinal lymph nodes cryobiopsies
Primary outcomes (1)
- measure
- Number of mediastinal cryobiopsies needed per patient to lead to a definite diagnosis.
- timeFrame
- 2 years
- description
- 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.
Secondary outcomes (1)
- measure
- Adequacy of mediastinal cryobiopsies for PDL1 analysis in lung cancer.
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available