title: Randomized comparison of power Doppler ultrasonography-guided core-needle biopsy with open surgical biopsy for the characterization of lymphadenopathies in patients with suspected lymphoma.
abstract: 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.
authors.affiliation: Department of Clinical Medicine and Surgery, Federico II University Medical School, Naples, Via S. Pansini 5, 80131, Naples, Italy. novypugliese@yahoo.it.
authors.forename: Novella
authors.initials: N
authors.lastname: Pugliese
authors.affiliation: Department of Clinical Medicine and Surgery, Federico II University Medical School, Naples, Via S. Pansini 5, 80131, Naples, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Di Perna
authors.affiliation: Department of Advanced Biomedical Sciences, Federico II University Medical School, Naples, Naples, Italy.
authors.forename: I
authors.initials: I
authors.lastname: Cozzolino
authors.affiliation: Department of Advanced Biomedical Sciences, Federico II University Medical School, Naples, Naples, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Ciancia
authors.affiliation: Department of Advanced Biomedical Sciences, Federico II University Medical School, Naples, Naples, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Pettinato
authors.affiliation: Department of Medicine and Surgery, University Medical School, Salerno, Salerno, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Zeppa
authors.affiliation: Department of Advanced Biomedical Sciences, Federico II University Medical School, Naples, Naples, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Varone
authors.affiliation: Department of Clinical Medicine and Surgery, Federico II University Medical School, Naples, Via S. Pansini 5, 80131, Naples, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Masone
authors.affiliation: Department of Clinical Medicine and Surgery, Federico II University Medical School, Naples, Via S. Pansini 5, 80131, Naples, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Cerchione
authors.affiliation: Department of Clinical Medicine and Surgery, Federico II University Medical School, Naples, Via S. Pansini 5, 80131, Naples, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Della Pepa
authors.affiliation: Department of Clinical Medicine and Surgery, Federico II University Medical School, Naples, Via S. Pansini 5, 80131, Naples, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Simeone
authors.affiliation: Department of Clinical Medicine and Surgery, Federico II University Medical School, Naples, Via S. Pansini 5, 80131, Naples, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Giordano
authors.affiliation: Department of Clinical Medicine and Surgery, Federico II University Medical School, Naples, Via S. Pansini 5, 80131, Naples, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Martinelli
authors.affiliation: Department of Economics, University of Molise, Campobasso, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Salvatore
authors.affiliation: Department of Clinical Medicine and Surgery, Federico II University Medical School, Naples, Via S. Pansini 5, 80131, Naples, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Pane
authors.affiliation: Department of Advanced Biomedical Sciences, Federico II University Medical School, Naples, Naples, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Picardi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001707:Biopsy, Needle / Q000379:methods / Q000592:standards*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000072281:Lymphadenopathy / Q000000981:diagnostic imaging* / Q000473:pathology*; D008223:Lymphoma / Q000000981:diagnostic imaging* / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D018608:Ultrasonography, Doppler / Q000379:methods / Q000592:standards*; D055815:Young Adult
keywords: Core-needle cutting biopsy; Lymphoma; Power Doppler ultrasonography