Mediastinal EBUS Cryobiopsy Study In Sweden (MECRIS)

Mediastinal Endobronchial Ultrasound Bronchoscopy Cryobiopsy Study In Sweden

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.

Study Overview

• Status: Recruiting
• Conditions: Lymphoma; Lung Cancer; Tuberculosis; Sarcoidosis; Mediastinal Lymphadenopathy
• Intervention / Treatment: Diagnostic test: Mediastinal lymph nodes cryobiopsies

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden
    • Recruiting
    • Respiratory medicine and allergy department, Skåne University Hospital
    • Contact: Hamid Akbarshahi, MD, PhD; Phone Number: 004646171000; Email: hamid.akbarshahi@med.lu.se
  • Umeå, Sweden
    • Recruiting
    • Norrlands Universitetssjukhus
    • Contact: Annelie Behndig, MD, PhD; Phone Number: 0907850000; Email: annelie.behndig@umu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients older than 18 years with mediastinal lymphadenopathy with a diameter greater than 1 cm who have indication to undergo sampling of lymph nodes for assessment according to clinical praxis.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Mediastinal lymph nodes cryobiopsies; EBUS Mediastinal lymph nodes cryobiopsies; Other Names: Mediastinal lymph nodes fine needle aspiration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of mediastinal cryobiopsies needed per patient to lead to a definite diagnosis.	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequacy of mediastinal cryobiopsies for PDL1 analysis in lung cancer.	Material leading to a definite answer is considered adequate.	2 years

Collaborators and Investigators

• Sponsor: Region Skane

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 29, 2024
• First Submitted That Met QC Criteria: March 29, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Lymphoma; Lung cancer; Tuberculosis; Sarcoidosis; Mediastinal lymphadenopathy
• Additional Relevant MeSH Terms: Infections; Immune System Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Hypersensitivity; Mycobacterium Infections; Hypersensitivity, Delayed; Tuberculosis; Lymphadenopathy; Sarcoidosis
• Other Study ID Numbers: 2023-06638-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No