Evidence map›Paper›PMID 36849566›Full record

Trial reportSurgical endoscopy2023

Comparison of two intraductal brush cytology devices for suspected malignant biliary strictures: randomized controlled trial.

Myrte Gorris, Nadine C M van Huijgevoort, Paul Fockens, Sybren L Meijer, Joanne Verheij, Rogier P Voermans, Roy L J van Wanrooij, Selma J Lekkerkerker, Jeanin E van Hooft

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Surgical endoscopy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.6field-weighted citation impact, top 15% 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.

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

3 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Review
  3. Diagnostic Approach to Biliary Strictures.Diagnostics (Basel, Switzerland) · 2025
    Review
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

9 authors at 3 institutions in 1 country.

Myrte Gorris *Gastroenterology and Hepatology, Amsterdam UMC Location University of Amsterdam, Amsterdam, The Netherlands.ORCID 0000-0001-6459-1434
Nadine C M van Huijgevoort *Gastroenterology and Hepatology, Amsterdam UMC Location University of Amsterdam, Amsterdam, The Netherlands.
Paul FockensGastroenterology and Hepatology, Amsterdam UMC Location University of Amsterdam, Amsterdam, The Netherlands.
Sybren L MeijerDepartment of Pathology, Amsterdam UMC Location University of Amsterdam, Amsterdam, The Netherlands.
Joanne VerheijDepartment of Pathology, Amsterdam UMC Location University of Amsterdam, Amsterdam, The Netherlands.
Rogier P VoermansGastroenterology and Hepatology, Amsterdam UMC Location University of Amsterdam, Amsterdam, The Netherlands.
Roy L J van WanrooijAmsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands.
Selma J LekkerkerkerGastroenterology and Hepatology, Amsterdam UMC Location University of Amsterdam, Amsterdam, The Netherlands.
Jeanin E van HooftDepartment of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands. j.e.van_Hooft@lumc.nl.
Amsterdam University Medical Centers · NLCancer Center Amsterdam · NLLeiden University Medical Center · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEndoscopic retrograde cholangiopancreatography (ERCP) with biliary brush cytology is commonly used to diagnose malignant pancreatobiliary strictures. This trial compared the sensitivity of two intraductal brush cytology devices.

methodsA randomized controlled trial in which consecutive patients with suspected malignant, extrahepatic biliary strictures were randomized (1:1) to a dense or conventional brush cytology device. Primary endpoint was sensitivity. Interim analysis was conducted after 50% of the patients completed follow-up. Results were interpreted by a data safety monitoring board.

resultsBetween June 2016 and June 2021, 64 patients were randomized to the dense (27 patients, 42%) or conventional brush (37 patients, 58%). Malignancy was diagnosed in 60 patients (94%) and benign disease in 4 patients (6%). Diagnoses were confirmed by histopathology in 34 patients (53%), cytopathology in 24 patients (38%), and clinical or radiological follow up in 6 patients (9%). Sensitivity of the dense brush was 50%, compared to 44% for the conventional brush (p = 0·785). DISCUSSION: The results of this randomized controlled trial showed that the sensitivity of a dense brush is not superior to a conventional brush for diagnosing malignant extrahepatic pancreatobiliary strictures. This trial was prematurely ended for reasons of futility.

trial registrationNetherlands Trial Register number; NTR5458.

Indexed as

Bile Duct NeoplasmsBiliary TractCholestasisPancreatic NeoplasmsCholangiopancreatography, Endoscopic RetrogradeConstriction, PathologicHumansSensitivity and SpecificityBiliary tract neoplasmsClinical pathologyEndoscopic retrograde cholangiopancreatographyPancreatic neoplasmsSensitivitySpecificity

Identifiers

PMID36849566
PMCPMC10234858
OpenAlexW4322421608

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.