Cryobiopsy for Suspected Malignant Peripheral Lymphadenopathy

NCT ID: NCT06120829

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 490 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-31
• Study Completion Date: 2025-12-31

Brief Summary

Cryobiopsy of peripheral lymph nodes with suspected malignant potential with comparison to standard core needle biopsy.

Detailed Description

Peripheral lymph node biopsy has long been accomplished to establish malignant and non-malignant diagnoses of lymphadenopathy. For several decades patients have undergone fine needle aspiration (FNA) and core needle biopsy (CNB) with patient's proceeding to excisional biopsy if initial less invasive procedures are inadequate. The diagnostic yield of FNA followed by CNB has remained stagnant since the 1990's with a yield range of 66-93.6% depending on multiple factors such as patient factors and malignancy type. In one study they found that between 25-30% of patients undergoing FNA followed by CNB ultimately proceed to excisional biopsy which carries a higher rate of morbidity than FNA or CNB with complications including: Seroma 6.4%, Hematoma 3.2%, Dehiscence 1.8% and prolonged pain 1.4%, vs. CNB which has a less than 1% overall complication rate. In several malignancy types, but especially in lymphoproliferative disorders there is a gap in the ability to diagnose via CNB.

After the introduction of cryobiopsy for bronchoscopic lymph node biopsy there was a significant increase in yields with the most prominent increase seen among the lymphoproliferative disorders with an increase from 69% to 95%. Cryobiopsy samples had a significant increase in architecture which is critical in proper diagnosis of lymphoproliferative disorders and genetic sequencing. Bronchoscopic cryobiopsies of mediastinal lymph nodes did not demonstrate higher complication rates compared to fine needle aspiration despite the higher yields.

Thus far in the literature the use of cryobiopsy for the diagnosis of superficial peripheral lymph nodes of suspected malignant potential has not yet been described. The use of the ERBE 2 platform for tissue biopsy has been demonstrated to improve the diagnostic yield in some situations, such as mediastinal lymphadenopathy, without statistically significant increase in complications. This study seeks to evaluate the safety, feasibility, and effectiveness of the use of the 1.1mm cryoprobe of this platform to increase diagnostic yield of peripherally obtainable lymph nodes of malignant potential without the need for additional procedures such as excisional biopsy that carry a significantly increased risk compared to current initial biopsy methods such as FNA and CNB.

Conditions

Cryobiopsy of Peripheral Lymph Nodes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Control Arm

FNA followed by Core Needle biopsy

Group Type: ACTIVE_COMPARATOR

Core Needle Biopsy

Intervention Type: PROCEDURE

Core Needle Biopsy

Experimental Arm

FNA followed by cryobiopsy through a introducer sheath

Group Type: EXPERIMENTAL

Cryobiopsy

Intervention Type: PROCEDURE

Use of 1.1mm ERBE 2 disposable cryoprobe for tissue sampling

Cryobiopsy

Intervention Type: DEVICE

Use of 1.1mm ERBE 2 disposable cryoprobe for tissue sampling

Interventions

Cryobiopsy

Use of 1.1mm ERBE 2 disposable cryoprobe for tissue sampling

Intervention Type: PROCEDURE

Cryobiopsy

Use of 1.1mm ERBE 2 disposable cryoprobe for tissue sampling

Intervention Type: DEVICE

Core Needle Biopsy

Core Needle Biopsy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age 18-89
• Suspected or confirmed malignancy with suspected involvement of peripheral lymph nodes based on CT, PET-CT or ultrasound imaging with a clinical need for additional tissue or staging by tissue sampling

Exclusion Criteria

• Age <18 or >89
• Patient preference
• Severe allergy to lidocaine precluding use
• Severe allergy to chlorhexidine precluding use
• Overlying Infection
• Active anticoagulation or anti-platelet therapy, with the exception of aspirin mono-therapy, that cannot be safely held as determined by the performing or prescribing physician.
• Major organs, vasculature or tissue that would preclude the safety of the procedure as determined by the performing physician.
• Inability to reach the lymph node through a core needle introducer sheath as determined by the performing physician.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

San Antonio Uniformed Services Health Education Consortium

FED

Sponsor Role: lead

Responsible Party

Stephen Goertzen

Pulmonary Critical Care Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Countries

United States

Facility Contacts

Steven Stoffel, DO

Role: primary

steven.t.stoffel.mil@health.mil

210-916-2153

Other Identifiers

C.20231002

Identifier Type: -

Identifier Source: org_study_id