Mediastinal EBUS Cryobiopsy Study In Sweden

NCT ID: NCT06347939

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2028-12-31

Brief 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.

Detailed Description

Endobronchial ultrasound bronchoscopy (EBUS) is an established method for sampling of mediastinal and hilar lymph nodes and masses. Cytology specimens can be obtained with transbronchial needle aspiration (EBUS TBNA), and this is a valuable tool in the diagnostic work up of lesions adjacent to central airways and in the staging of lung cancer. EBUS TBNA is a robust method that shows excellent results in diagnosing lung cancer cases with a reported diagnostic yield up to 90% from multiple studies. EBUS TBNA is a safe procedure with reported complications in 1,2 - 3,6% of cases.

In clinical situations where non-malignant diseases (e.g. sarcoidosis, tuberculosis) or malignancies other than lung cancer (e.g. lymphoma) affect the mediastinum is the efficacy of EBUS TBNA relatively limited and these cases often require histopathological evaluation rather than cytological assessment.

EBUS TBMCB (EndoBronchial UltraSound TransBronchial Mediastinal CryoBiopsy) is a novel method of obtaining cryobiopsies for histopathology from mediastinal lesions, which has previously not been possible with endobronchial procedures. This method is becoming more utilised internationally after the publication of the first studies examining its safety and efficacy. In the last couple of years has EBUS TBMCB been evaluated in two randomized studies from the same study group and a few observational studies where adding EBUS TBMCB to EBUS TBNA showed an increase in diagnostic yield without adding significant adverse events. The sensitivity of EBUS TBMCB were similar to that of EBUS TBNA in cases of lung cancer but there was found, in all studies, a significant increase of diagnostic yield in cases of non-malignant diseases and metastases from extra thoracic tumours.

There are however some aspects of this novel method yet not studied like the number of biopsies needed from a lesion to collect adequate material for histopathological evaluation. At the thoracic oncology diagnostics units at Skåne University Hospital and Umeå University hospital, EBUS TBMCB has been introduced in clinical practice, performed by experienced bronchoscopists. In recognition of the need for further clarification regarding several aspects of this novel method the investigators plan to collect data prospectively and systematically from EBUS TBMCB procedures.

Our study is a prospective observational non-randomized clinical trial where all the patients undergo the same procedure and every patient's own samples are compared to each other. The investigators conduct EBUS TBNA and EBUS TBMCB to all the study participants and the investigators are numbering the cryobiopsy samples 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 patient. 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.

Data will be collected in both sites from all EBUS TBMCB procedures eligible according to inclusion criteria, where patients agree to partake in the study, until 200 cases are reached.

Conditions

Mediastinal Lymphadenopathy; Lung Cancer; Sarcoidosis; Lymphoma; Tuberculosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Mediastinal lymph nodes cryobiopsies

Intervention Type: DIAGNOSTIC_TEST

EBUS Mediastinal lymph nodes cryobiopsies

Interventions

Mediastinal lymph nodes cryobiopsies

EBUS Mediastinal lymph nodes cryobiopsies

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Mediastinal lymph nodes fine needle aspiration

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Hamid Akbarshahi

Pulmonary medicine specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Respiratory medicine and allergy department, Skåne University Hospital

Lund, , Sweden

Site Status: RECRUITING

Norrlands universitetssjukhus

Umeå, , Sweden

Site Status: RECRUITING

Countries

Sweden

Facility Contacts

Hamid Akbarshahi, MD, PhD

Role: primary

hamid.akbarshahi@med.lu.se

004646171000

Annelie Behndig, MD, PhD

Role: primary

annelie.behndig@umu.se

0907850000

Other Identifiers

2023-06638-01

Identifier Type: -

Identifier Source: org_study_id