Evidence map›Paper›PMID 28130574›Full record

Trial reportAnnals of hematology2017

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

Novella Pugliese, M Di Perna, I Cozzolino, G Ciancia, G Pettinato, P Zeppa, V Varone, S Masone, C Cerchione, R Della Pepa and 6 more

Abstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of hematology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Novella PuglieseDepartment of Clinical Medicine and Surgery, Federico II University Medical School, Naples, Via S. Pansini 5, 80131, Naples, Italy. novypugliese@yahoo.it.
M Di PernaDepartment of Clinical Medicine and Surgery, Federico II University Medical School, Naples, Via S. Pansini 5, 80131, Naples, Italy.
I CozzolinoDepartment of Advanced Biomedical Sciences, Federico II University Medical School, Naples, Naples, Italy.
G CianciaDepartment of Advanced Biomedical Sciences, Federico II University Medical School, Naples, Naples, Italy.
G PettinatoDepartment of Advanced Biomedical Sciences, Federico II University Medical School, Naples, Naples, Italy.
P ZeppaDepartment of Medicine and Surgery, University Medical School, Salerno, Salerno, Italy.
V VaroneDepartment of Advanced Biomedical Sciences, Federico II University Medical School, Naples, Naples, Italy.
S MasoneDepartment of Clinical Medicine and Surgery, Federico II University Medical School, Naples, Via S. Pansini 5, 80131, Naples, Italy.
C CerchioneDepartment of Clinical Medicine and Surgery, Federico II University Medical School, Naples, Via S. Pansini 5, 80131, Naples, Italy.
R Della PepaDepartment of Clinical Medicine and Surgery, Federico II University Medical School, Naples, Via S. Pansini 5, 80131, Naples, Italy.
L SimeoneDepartment of Clinical Medicine and Surgery, Federico II University Medical School, Naples, Via S. Pansini 5, 80131, Naples, Italy.
C GiordanoDepartment of Clinical Medicine and Surgery, Federico II University Medical School, Naples, Via S. Pansini 5, 80131, Naples, Italy.
V MartinelliDepartment of Clinical Medicine and Surgery, Federico II University Medical School, Naples, Via S. Pansini 5, 80131, Naples, Italy.
C SalvatoreDepartment of Economics, University of Molise, Campobasso, Italy.
F PaneDepartment of Clinical Medicine and Surgery, Federico II University Medical School, Naples, Via S. Pansini 5, 80131, Naples, Italy.
M PicardiDepartment of Advanced Biomedical Sciences, Federico II University Medical School, Naples, Naples, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

AdolescentAdultAgedBiopsy, NeedleFemaleFollow-Up StudiesHumansLymphadenopathyLymphomaMaleMiddle AgedUltrasonography, DopplerYoung AdultCore-needle cutting biopsyLymphomaPower Doppler ultrasonography

Identifiers

PMID28130574
PMCPMC5334396

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.