Evidence map›Paper›PMID 40689505›Full record

Observational studyHepatology communications2025

The incidence and predictors of false-negative pancreatobiliary fluorescence in situ hybridization (PB-FISH) in biliary strictures: A prospective study.

Manik Aggarwal, Gregory J Gores, Eric J Vargas, Andrew C Storm, Ryan J Law, Barham K Abu Dayyeh, John A Martin, Bret T Petersen, John E Eaton, Sumera I Ilyas and 2 more

Registry-linked trialAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Hepatology communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04572711 (Prospective Evaluation of Biliary Tissue Sampling With ERCP), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

NCT04572711 completednot on this map

Prospective Evaluation of Biliary Tissue Sampling With ERCP

TypeobservationalSponsorMayo ClinicRan2020 to 2025Enrolled327ConditionsCholangiopancreatography, Endoscopic Retrograde, Biliary Stricture, Biliary Tract Diseases, Cholangiocarcinoma
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

12 authors.

Manik AggarwalDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.ORCID 0000-0002-6087-1700
Gregory J GoresDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.ORCID 0000-0003-3151-009
Eric J VargasDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.ORCID 0000-0002-8886-0376
Andrew C StormDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.ORCID 0000-0003-0619-5235
Ryan J LawDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Barham K Abu DayyehDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
John A MartinDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Bret T PetersenDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
John E EatonDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Sumera I IlyasDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Lewis R RobertsDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.ORCID 0000-0001-7885-8574
Vinay ChandrasekharaDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.ORCID 0000-0001-6209-9905

Funding

Project 4: ImmunovirotherapyP50CA210964 · NCI · MAYO CLINIC ROCHESTER · PI Zongming Eric Chen · 2018 to 2026
$20.5M
NCI NIH HHS P50 CA210964
6 · The paper itself

Abstract

backgroundFluorescence in situ hybridization (FISH) is recommended as part of multimodality sampling in the evaluation of biliary strictures, but can be false negative in 40%-50% cases. The aim of this study was to comprehensively assess predictors of false-negative FISH in patients with biliary strictures.

methodsPatients undergoing tissue sampling for biliary strictures from October 20 to February 22 were prospectively enrolled (NCT04572711). Procedural factors such as sampling techniques, order, and utilization of combination sampling were recorded. Results of an optimized pancreatobiliary FISH panel with locus-specific probes for 1q21, 7p12, 8q24, and 9p21 were reported per guidelines. Statistical analyses were performed using BlueSky Statistics v.10.3.1, R package v8.81.

resultsOf 327 patients, 93 (28.5%) were diagnosed with malignancy. A false-negative pancreatobiliary fluorescence in situ hybridization (PB-FISH) was reported in 40 (43.1%) patients. A history of primary sclerosing cholangitis was associated with lower odds of having a false-negative PB-FISH (aOR=0.38, 95% CI=0.16-0.82, p=0.02), whereas a hilar stricture was associated with a significantly higher false-negative PB-FISH in those with cholangiocarcinoma (aOR=3.2 [1.4-7.9], p=0.009). Dilation of biliary strictures prior to brushing was not associated with a lower rate of false-negative PB-FISH.

conclusionsIn this prospective study, hilar strictures were more likely to have false-negative PB-FISH. Dilation of strictures did not affect PB-FISH performance. These results can help guide PB-FISH interpretation.

Indexed as

Bile Duct NeoplasmsIn Situ Hybridization, FluorescenceAdultAgedAged, 80 and overConstriction, PathologicFalse Negative ReactionsFemaleHumansIncidenceMaleMiddle AgedProspective Studiesbiliarycancercholangiocarcinomastricture

Identifiers

PMID40689505
PMCPMC12262981

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.