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

NCT07352267 | Not Yet Recruiting DMC

• 1 other identifier: DETECTION-LYM
• Study Type: interventional
• Target: 470
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Mediastinal and Hilar Lymphadenopathy

Keywords

Endobronchial ultrasound; Transbronchial needle aspiration; Transbronchial mediastinal cryobiopsy; Lymphoma

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield

  7 days after sampling

Secondary Outcomes (3)

• Diagnostic sensitivity

  7 days after smpling

• Incidence of complications

  7 days after sampling

• Rate of specimen adequacy

  7 days after sampling

Study Arms (2)

Endobronchial ultrasound-guided transbronchial needle aspiration

EXPERIMENTAL

Procedure: Endobronchial ultrasound-guided transbronchial needle aspiration

Endobronchial ultasound-guided transbronchial mediastinal cryobiopsy

EXPERIMENTAL

Procedure: Endobronchial ultrasound-guided tranbronchial mediastinal cryobiopsy

Interventions

Endobronchial ultrasound-guided tranbronchial mediastinal cryobiopsy PROCEDURE

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.

Endobronchial ultasound-guided transbronchial mediastinal cryobiopsy

Endobronchial ultrasound-guided transbronchial needle aspiration PROCEDURE

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.

Endobronchial ultrasound-guided transbronchial needle aspiration

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: January 20, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: January 20, 2026

Record last verified: 2026-01