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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

470

Phase

  • 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

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
Intervention / Treatment
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

Outcome Measure
Time Frame
Diagnostic yield
Time Frame: 7 days after sampling
7 days after sampling

Secondary Outcome Measures

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

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)

March 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

January 11, 2026

First Submitted That Met QC Criteria

January 11, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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