Neoplasms

Blood and Lymph Conditions

Immune System Diseases

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Lymphoma

Lymphadenopathy

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FNA followed by cryobiopsy through a introducer sheath

Use of 1.1mm ERBE 2 disposable cryoprobe for tissue sampling

Cryobiopsy

Core Needle Biopsy

Steven Stoffel, DO

Michal Sobieszczyk, MD

Stephen Goertzen, DO

Steven Stofffel, DO

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

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.

Cryobiopsy for Suspected Malignant Peripheral Lymphadenopathy

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Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Cryobiopsy for Suspected Malignant Peripheral Lymphadenopathy	NCT06120829	Cryobiopsy of P...	Cryobiopsy Cryobiopsy Core Needle Bio...	18 Years - 89 Years	San Antonio Uniformed Services Health Education Consortium
Cryobiopsy for Suspected Malignant Peripheral Lymphadenopathy	NCT06120829	Cryobiopsy of P...	Cryobiopsy Cryobiopsy Core Needle Bio...	18 Years - 89 Years	San Antonio Uniformed Services Health Education Consortium

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