Evidence map›Paper›PMID 32213013›Full record

Trial reportUnited European gastroenterology journal2020

Multicenter, randomized comparison of the diagnostic accuracy of 19-gauge stainless steel and nitinol-based needles for endoscopic ultrasound-guided fine-needle biopsy of solid pancreatic masses.

Alexander Hann, Sonja Epp, Lothar Veits, Ulrich Rosien, Julian Siegel, Oliver Möschler, Wolfram Bohle, Alexander Meining

Registry-linked trialOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in United European gastroenterology journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02909530 (Comparison Between the Olympus EZ Shot 3Plus 19G and EZ Shot 2 19G in Endoscopic Ultrasound-guided Fine Needle Biopsy of Solid Pancreatic Masses), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.1field-weighted citation impact, top 46% of its field
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.

NCT02909530 nacompletednot on this map

Comparison Between the Olympus EZ Shot 3Plus 19G and EZ Shot 2 19G in Endoscopic Ultrasound-guided Fine Needle Biopsy of Solid Pancreatic Masses

TypeinterventionalSponsorUniversity of UlmRan2016 to 2018Enrolled46ConditionsPancreatic NeoplasmsArmsEUS-FNB with EZ Shot 3Plus first, EUS-FNB with EZ Shot 2 19G first
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Article
  3. UEGWeek: The modern School of Athens.United European gastroenterology journal · 2021
    Article
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

8 authors at 5 institutions in 1 country.

Alexander HannInterventional and Experimental Endoscopy, Department of Internal Medicine I, Ulm University, Ulm, Germany.ORCID 0000-0001-8035-3559
Sonja EppInterventional and Experimental Endoscopy, Department of Internal Medicine I, Ulm University, Ulm, Germany.
Lothar VeitsInstitute of Pathology, Klinikum Bayreuth, Bayreuth, Germany.
Ulrich RosienDepartment of Internal Medicine, Israelitic Hospital, Hamburg, Germany.
Julian SiegelDepartment of Internal Medicine, Israelitic Hospital, Hamburg, Germany.
Oliver MöschlerDepartment of Gastroenterology, Marienhospital Osnabrück, Osnabrück, Germany.
Wolfram BohleDepartment of Gastroenterology, Katharinenhospital, Klinikum Stuttgart, Stuttgart, Germany.
Alexander MeiningInterventional and Experimental Endoscopy, Department of Internal Medicine I, Ulm University, Ulm, Germany.
Universität Ulm · DEIsraelitisches Krankenhaus · DEBayreuth Medical Center · DEKatharinenhospital · DEMarienhospital Osnabrück · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe use of 19-gauge (G) stainless steel needles for endoscopic ultrasound-guided fine-needle biopsy of a pancreatic mass often results in technical difficulties due to an inability to advance the relatively rigid needle out of the endoscope. More flexible nitinol-based needles might decrease such technical difficulties and thus increase diagnostic accuracy.

objectiveIn this prospective multicenter randomized single-blinded study we compared the diagnostic value of those two needle types in patients with a solid pancreatic lesion.

methodsPatients with a solid pancreatic mass were diagnosed with endoscopic ultrasound-guided fine-needle biopsy using one puncture with each needle in a randomized fashion. The primary endpoint was the diagnostic accuracy of each needle. Secondary endpoints included time for puncture, amount of tumour tissue obtained, and technical failure. Histological specimens were centrally reviewed by a pathologist blinded to the final needle type and final diagnosis (ClinicalTrials.gov Identifier: NCT02909530).

resultsOut of 46 prospectively recruited patients, central pathological examination was available for 41. Diagnostic accuracy for the two needles combined was 87.8%. Diagnostic accuracy was 66% and 68% using the stainless steel- and nitinol-based needle respectively. Time spent for puncturing was 137 ± 61 s (mean ± standard deviation) for the stainless steel and 111 ± 53 s for the nitinol-based needle (

conclusionsUsage of a nitinol-based 19-G needle failed to present a significant superior accuracy compared with a stainless steel needle in endoscopic ultrasound-guided fine-needle biopsy of solid pancreatic lesions.

Indexed as

NeedlesAdultAgedAged, 80 and overAlloysEndoscopic Ultrasound-Guided Fine Needle AspirationFemaleFollow-Up StudiesHumansMaleMiddle AgedPancreasPancreatic NeoplasmsProspective StudiesStainless SteelAlloysnitinolStainless SteelEndoscopic ultrasoundEUS-FNBnitinol-based needlepancreatic mass

Identifiers

PMID32213013
PMCPMC7184661
OpenAlexW2987635936

What OpenQuestion holds

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Registered trials

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.