Diagnostic Value and Safety of Endobronchial Ultrasound-guided Transbronchial Mediastinal Cryobiopsy Versus Transbronchial Needle Aspiration in the Diagnosis of Lymphoma: a Randomized Controlled Trial

January 11, 2026 updated by: Gang Hou, China-Japan Friendship Hospital

The goal of this clinical trial is to learn which of two minimally invasive procedures is better at safely diagnosing lymphoma in the mediastinum (chest) in adults (aged 18 and older) who are suspected to have either a new or a returning (relapsed) lymphoma. The main questions it aims to answer are:

Which procedure, endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (EBUS-TBMC) or endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), has a higher success rate in obtaining a definitive diagnosis? Is one procedure safer than the other in terms of complications? Researchers will compare the EBUS-TBMC group to the EBUS-TBNA group to see if the cryobiopsy technique leads to better diagnostic results and has a similar or better safety profile.

Participants will:

Be randomly assigned to undergo one of the two diagnostic procedures (EBUS-TBMC or EBUS-TBNA) during a single bronchoscopy session.

Have their tissue samples analyzed by pathologists. Be followed clinically for at least 6 months to confirm the final diagnosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
470

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years.
  • Presence of mediastinal lymphadenopathy of unknown etiology.
  • Clinical suspicion of lymphoma, based on any of the following:

Previous history of lymphoma (suspected relapse). Presence of lymphoma at another site. Clinical and radiographic findings suggestive of new isolated mediastinal lymphoma (e.g., isolated idiopathic bulky mediastinal adenopathy with or without systemic symptoms), as assessed by the study bronchoscopists.

Exclusion Criteria:

  • A more probable alternative cause for lymphadenopathy is identified (e.g., lung cancer or other non-lymphoproliferative malignancies).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Endobronchial ultrasound-guided transbronchial needle aspiration
Procedure: Endobronchial ultrasound-guided transbronchial needle aspiration
After the target lymph nodes are determined and the safety of needle aspiration is ensured, a 19-G needle will be placed in the working channel of the EBUS scope. The tip of the sheath of the needle will be visible on the endobronchial view, and the needle will then be allowed to pierce the airway wall and enter the lymph node using the jabbing technique under direct ultrasound guidance. A 50-mL syringe will be used to collect 20 mL of aspirates, which will be maintained for 20 s. Each lymph node will be sampled five times to optimize the diagnostic yield. Five passes per node are planned. The samples will not be evaluated on site.
Experimental: Endobronchial ultasound-guided transbronchial mediastinal cryobiopsy
Procedure: Endobronchial ultrasound-guided tranbronchial mediastinal cryobiopsy
After the target lymph node is located (vascular structures will be excluded via the Doppler function), a tunnel will be made between the target lymph node and the airway wall using a 19-G needle. Subsequently, a 1.1-mm cryoprobe (Erbe 20 402-401, ERBE, Tübingen, Germany) will be inserted through the tunnel and positioned within the target lymph node under EBUS monitoring. The distance between the cryoprobe tip and the lymph node edge will be confirmed to be >5 mm in all four directions. Afterward, the probe will be cooled in liquid carbon dioxide for 5-9 s. A total of three passes will be performed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Diagnostic yield
Time Frame: 7 days after sampling
7 days after sampling

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Diagnostic sensitivity
Time Frame: 7 days after smpling
7 days after smpling
Incidence of complications
Time Frame: 7 days after sampling
7 days after sampling
Rate of specimen adequacy
Time Frame: 7 days after sampling
7 days after sampling

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China-Japan Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DETECTION-LYM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mediastinal and Hilar Lymphadenopathy

Clinical Trials on Endobronchial ultrasound-guided transbronchial needle aspiration

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings