Mediastinal EBUS Cryobiopsy Study In Sweden

NCT06347939 | Recruiting

• 1 other identifier: 2023-06638-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Mediastinal Lymphadenopathy; Lung Cancer; Sarcoidosis; Lymphoma; Tuberculosis

Keywords

Mediastinal lymphadenopathy; Lung cancer; Sarcoidosis; Tuberculosis; Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adequacy of mediastinal cryobiopsies for PDL1 analysis in lung cancer.

  2 years

Study Arms (1)

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

Interventions

Mediastinal lymph nodes cryobiopsies DIAGNOSTIC_TEST

EBUS Mediastinal lymph nodes cryobiopsies

Also known as: Mediastinal lymph nodes fine needle aspiration

All the patients undergo the same procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Skane: lead

Study Sites (2)

Respiratory medicine and allergy department, Skåne University Hospital

Lund, Sweden

RECRUITING

Norrlands universitetssjukhus

Umeå, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Lymph node biopsies

MeSH Terms

Conditions

Lung Neoplasms; Sarcoidosis; Lymphoma; Tuberculosis

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Neoplasms by Histologic Type; Immunoproliferative Disorders; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonary medicine specialist

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 17, 2025

Record last verified: 2025-06

Locations

SE (2)