Core needle biopsy as a front line diagnostic approach for lymphoma patients

Pruneri, Giancarlo; Gigli, Federica; Raviele, Paola Rafaniello; Gardellini, Angelo; Raimondi, Sara; Fiori, Elvio De; Preda, Lorenzo; Viale, Giuseppe; Martinelli, Giovanni; Laszlò, Daniele

doi:10.1002/hon.2150

Cited by 14 publications

(22 citation statements)

References 6 publications

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“…Based on previous studies, we estimated a sensitivity rate at standard biopsy of 78% [5] and at PDUS-guided CNCB of 96.5% [14, 18]; hence, a certain number of patients could be underdiagnosed with OSB approach. To detect more than 10% sensitivity improvement (for the superiority test), 332 patients were needed, when using a two-sided type I error of 5% and 99% statistical power.…”

Section: Methodsmentioning

confidence: 99%

“…The result is a high-resolution quality examination that allows better detection of both superficial and deep-seated malignant lymphadenopathies compared with results obtained with gray-scale US [13]. Regarding biopsy needle devices, the latest Menghini needles have ultrathin sharpened cannula with trocar stylet and automatic aspiration with tiny battery-powered vacuum [14]. These characteristics make particularly effective the needle devices with large gauge [15].…”

Section: Introductionmentioning

confidence: 99%

“…These characteristics make particularly effective the needle devices with large gauge [15]. Under PDUS guidance, the tip of cutting needle can be careful positioning into the most significant target, obtaining histological suction of the core of nodal lesion [14–16]. Nevertheless, few clear indications for performing such procedure are available.…”

Section: Introductionmentioning

confidence: 99%

“…The Lugano classification for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma recommend core-needle biopsy when surgical intervention is not possible and to document relapse [2]. However, the existing guidelines are not evidence based, a uniform program for optimal imaging guidance is lacking, and the characteristics of biopsy needle, i.e., gauge, length, tip configurations, and sampling mechanisms, are still a matter of opinion among experts [1, 14, 16]. Thus, this approach requires validation with randomized studies.…”

Section: Introductionmentioning

confidence: 99%

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Randomized comparison of power Doppler ultrasonography-guided core-needle biopsy with open surgical biopsy for the characterization of lymphadenopathies in patients with suspected lymphoma

et al. 2017

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The sensitivity of lymph node core-needle biopsy under imaging guidance requires validation. We employed power Doppler ultrasonography (PDUS) to select the lymph node most suspected of malignancy and to histologically characterize it through the use of large cutting needle. Institutional review board approval and informed consent were obtained for this randomized clinical trial. In a single center between 1 January 2009 and 31 December 2015, patients with lymph node enlargement suspected for lymphoma were randomly assigned (1:1) to biopsy with either standard surgery or PDUS-guided 16-gauge modified Menghini needle. The primary endpoint was the superiority of sensitivity for the diagnosis of malignancy for core-needle cutting biopsy (CNCB). Secondary endpoints were times to biopsy, complications, and costs. A total of 376 patients were randomized into the two arms and received allocated biopsy. However, four patients undergoing CNCB were excluded for inadequate samples; thus, 372 patients were analyzed. Sensitivity for the detection of malignancy was significantly better for PDUS-guided CNCB [98.8%; 95% confidence interval (CI), 95.9–99.9] than standard biopsy (88.7%; 95% CI, 82.9–93; P < 0.001). For all secondary endpoints, the comparison was significantly disadvantageous for conventional approach. In particular, estimated cost per biopsy performed with standard surgery was 24-fold higher compared with that performed with CNCB. The presence of satellite enlarged reactive and/or necrotic lymph nodes may impair the success of an open surgical biopsy (OSB). PDUS and CNCB with adequate gauge are diagnostic tools that enable effective, safe, fast, and low-cost routine biopsy for patients with suspected lymphoma, avoiding psychological and physical pain of an unnecessary surgical intervention.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Randomized comparison of power Doppler ultrasonography-guided core-needle biopsy with open surgical biopsy for the characterization of lymphadenopathies in patients with suspected lymphoma

et al. 2017

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“…These characteristics make particularly effective the needle devices with large gauge [15]. Under PDUS guidance, the tip of cutting needle can be careful positioning into the most significant target, obtaining histological suction of the core of nodal lesion [14][15][16]. Nevertheless, few clear indications for performing such procedure are available.…”

Section: Introductionmentioning

confidence: 99%

Randomized Comparison of Power Doppler Ultrasonography-Guided Core-Needle Biopsy with Open Surgical Biopsy for the Characterization of Lymphadenopathies in Patients with Suspected Lymphoma

Pugliese¹,

Perna²,

Cozzolino

et al. 2016

Blood

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Background In case of clinical suspicion of lymphoma, the histological examination of lymphadenopathy is essential for defining a correct diagnosis and for developing a proper treatment plan. An open surgical biopsy (OSB) is still the "gold standard", owing to the large amount of tissue obtained. The sensitivity of lymph node core-needle biopsy under imaging guidance requires validation. Aims This randomized study compared the ultrasound-guided core-needle cutting biopsy (CNCB) approach with OSB approach. Patient and methods Institutional review board approval and informed consent were obtained. In a single center between 1 January 2009 and 31 December 2015, patients with lymph node enlargement suspected for lymphoma were randomly assigned (1:1) to biopsy with either OSB (standard group) or ultrasound-guided 16 gauge modified Menghini needle (core-needle group). In the core-needle group, the lymph node to undergone biopsy was determined by power Doppler US, in particular, the main criterion to select the node to be biopsied was the hypervascularization. The primary endpoint was to test the superiority of sensitivity for diagnosis of malignancy for ultrasound-guided CNCB compared with OSB. Secondary endpoints were negative predictive values, likelihood ratio of negative test, biopsy related complications, costs and times to biopsy. Results A total of 372 patients were randomized either to standard group (N= 187) or core-needle group (N= 185). Sensitivity for detection of malignancy was significantly better for US-guided CNCB [98.8%; 95% confidence interval (CI), 95.9-99.9] than standard biopsy [88.7%; 95% CI, 82.9-93] (P<0.001). Therefore, the study objective to show superiority of US-guided CNCB versus OSB was achieved, being the sensitivity rate of experimental approach significantly higher than standard approach. For all secondary endpoints, the comparison was significantly disadvantageous for standard approach. The negative predictive value was 50% (19 of 38; 95% CI, 33.4-66.6) for OSB and 84.6% (11 of 13; 95% CI, 54.5-98.1) for US-guided CNCB (P= 0.014). The negative likelihood ratio was 0.11 (95% CI: 0.07-0.17) for OSB and 0.01 (95% CI: 0.00-0.05) for US-guided CNCB, confirming the value of the US-guided CNCB for detecting malignancy. Patients who received standard biopsy had significantly more procedure-related complications (P<0.001). Furthermore, estimated cost per biopsy performed with standard surgery was 24-fold higher compared with that performed with US-guided CNCB (P<0.0001). The median waiting time for performance of biopsy (from procedure indication to perform itself), was 4 days with a range of 1 to 10 days in the core-needle group. By contrast, it was 16 days, with a range of 5 to 34 days in the standard group (P<0.0001). Conclusions This study is the first to compare in a randomized fashion the sensitivity of US-guided CNCB and OSB in detecting lymphoma. Power Doppler US and CNCB are diagnostic tools that enable effective, safe, fast and low-cost routine biopsy for patients with suspected lymphoma, avoiding psychological and physical pain of an unnecessary surgical intervention. We suggest this approach as first-line mini-invasive procedure for patients with a suspected lymphoma and not merely when surgical intervention is not possible, or to document relapse. Disclosures No relevant conflicts of interest to declare.

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Ultrasonography‐guided core‐needle biopsy of lymphadenopathies suspected of lymphoma: Analysis on diagnostic efficacy and safety of 1000 front‐line biopsies in a multicenter Italian study

Picardi

Giordano

Vigliar

et al. 2023

Hematological Oncology

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The reliability and safety of front‐line ultrasonography guided core needle biopsy (UG‐CNB) performed with specific uniform approach have never been evaluated in a large series of patients with lymphadenopathies suspected of lymphoma. The aim of this study was to assess the overall accuracy of UG‐CNB in the lymph node histological diagnosis, using a standard reference based on pathologist consensus, molecular biology, and/or surgery. We retrospectively checked the findings concerning the application of lymph node UG‐CNB from four Italian clinical units that routinely utilized 16‐gauge diameter modified Menghini needle under power‐Doppler ultrasonographic guidance. A data schedule was sent to all centers to investigate the information regarding techniques, results, and complications of lymph node UG‐CNB in untreated patients over a 12‐year period. Overall, 1000 (superficial target, n = 750; deep‐seated target, n = 250) biopsies have been evaluated in 1000 patients; other 48 biopsies (4.5%), screened in the same period, were excluded because inadequate for a confident histological diagnosis. Most patients were suffering from lymphomas (aggressive B‐cell non‐Hodgkin lymphoma [aBc‐NHL], 309 cases; indolent B‐cell [iBc]‐NHL, 279 cases; Hodgkin lymphoma [HL], 212 cases; and nodal peripheral T‐cell [NPTC]‐NHL, 30 cases) and 100 cases from metastatic carcinoma; 70 patients had non‐malignant disorders. The majority of CNB results met at least one criterion of the composite reference standard. The overall accuracy of the micro‐histological sampling was 97% (95% confidence interval: 95%–98%) for the series. The sensitivity of UG‐CNB for the detection of aBc‐NHL was 100%, for iBc‐NHL 95%, for HL 93%, and for NPTC‐NHL 90%, with an overall false negative rate of 3.3%. The complication rate was low (6% for all complications); no patient suffered from biopsy‐related complications of grade >2 according to the Common Terminology Criteria for Adverse Events. Lymph node UG‐CNB as mini‐invasive diagnostic procedure is effective with minimal risk for the patient.

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Core needle biopsy as a front line diagnostic approach for lymphoma patients

Cited by 14 publications

References 6 publications

Randomized comparison of power Doppler ultrasonography-guided core-needle biopsy with open surgical biopsy for the characterization of lymphadenopathies in patients with suspected lymphoma

Randomized comparison of power Doppler ultrasonography-guided core-needle biopsy with open surgical biopsy for the characterization of lymphadenopathies in patients with suspected lymphoma

Randomized Comparison of Power Doppler Ultrasonography-Guided Core-Needle Biopsy with Open Surgical Biopsy for the Characterization of Lymphadenopathies in Patients with Suspected Lymphoma

Ultrasonography‐guided core‐needle biopsy of lymphadenopathies suspected of lymphoma: Analysis on diagnostic efficacy and safety of 1000 front‐line biopsies in a multicenter Italian study

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