Evidence map›Paper›PMID 21741642›Full record

Trial reportGastrointestinal endoscopy2011

Real-time increased detection of neoplastic tissue in Barrett's esophagus with probe-based confocal laser endomicroscopy: final results of an international multicenter, prospective, randomized, controlled trial.

Prateek Sharma, Alexander R Meining, Emmanuel Coron, Charles J Lightdale, Herbert C Wolfsen, Ajay Bansal, Monther Bajbouj, Jean-Paul Galmiche, Julian A Abrams, Amit Rastogi and 4 more

3 registry-linked trialsOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Gastrointestinal endoscopy, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 113 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
113citing papers in PubMed, 3 pooled it
25.9field-weighted citation impact, top 1% 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.

NCT00795184 nacompletednot on this map

Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy

TypeinterventionalSponsorMauna Kea TechnologiesRan2008 to 2010Enrolled122ConditionsBarrett Syndrome, Barrett's Syndrome, Barrett's Esophagus, Barrett EsophagusArmsImaging procedures (NBI), HDWLE, pCLE
NCT01793246 completednot on this mapstarted 2013, after this paper: background citation

Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy: Discrete Pulmonary Lesions and Acute Rejection in Transplanted Lungs

TypeobservationalSponsorMauna Kea TechnologiesRan2013 to 2016Enrolled99ConditionsLung Neoplasms, Disorder Related to Lung TransplantationArmsprobe based laser endomicroscopy (pCLE)
NCT02922049 nacompletednot on this mapstarted 2016, after this paper: background citation

Probe-based Confocal Laser Endomicroscopy in Accurate Histopathologic Diagnosis of Neoplastic Gastrointestinal Lesion

TypeinterventionalSponsorInstitute for Clinical and Experimental MedicineRan2016 to 2020Enrolled67ConditionsBarrett's EsophagusArmsBiopsies with histopathology
3 · Its place in the literature

Who cites it

113 citing papers in PubMed, 3 syntheses or guidelines pooled it, 280 citations in OpenAlex.

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  12. Improving esophageal cancer screening across the globe: Translating knowledge into action.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2024
    Review
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53 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 10 institutions in 3 countries.

Prateek SharmaVeterans Affairs Medical Center and University of Kansas School of Medicine, Kansas City, Missouri, USA. psharma@kumc.edu
Alexander R Meining
Emmanuel Coron
Charles J Lightdale
Herbert C Wolfsen
Ajay Bansal
Monther Bajbouj
Jean-Paul Galmiche
Julian A Abrams
Amit Rastogi
Neil Gupta
Joel E Michalek
Gregory Y Lauwers
Michael B Wallace
University of Kansas · USCentre Hospitalier Universitaire de Nantes · FRKlinikum rechts der Isar · DEColumbia University · USColumbia University Irving Medical Center · USHarvard University Press · USKansas City VA Medical Center · USMayo Clinic · USMayo Clinic in Florida · USThe University of Texas Health Science Center at San Antonio · US

Funding

Risk factors for site-specific metastasis in esophageal cancerK07CA132892 · NCI · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI ABRAMS, JULIAN · 2008 to 2012
$777k
NCI NIH HHS K07 CA132892
6 · The paper itself

Abstract

backgroundProbe-based confocal laser endomicroscopy (pCLE) allows real-time detection of neoplastic Barrett's esophagus (BE) tissue. However, the accuracy of pCLE in real time has not yet been extensively evaluated.

objectiveTo compare the sensitivity and specificity of pCLE in addition to high-definition white-light endoscopy (HD-WLE) with HD-WLE alone for the detection of high-grade dysplasia (HGD) and early carcinoma (EC) in BE.

designInternational, prospective, multicenter, randomized, controlled trial.

settingFive tertiary referral centers. PATIENTS: A total of 101 consecutive BE patients presenting for surveillance or endoscopic treatment of HGD/EC.

interventionsAll patients were examined by HD-WLE, narrow-band imaging (NBI), and pCLE, and the findings were recorded before biopsy samples were obtained. The order of HD-WLE and NBI was randomized and performed by 2 independent, blinded endoscopists. All suspicious lesions on HD-WLE or NBI and 4-quadrant random locations were documented. These locations were examined by pCLE, and a presumptive diagnosis of benign or neoplastic (HGD/EC) tissue was made in real time. Finally, biopsies were taken from all locations and were reviewed by a central pathologist, blinded to endoscopic and pCLE data. MAIN OUTCOME MEASUREMENTS: Diagnostic characteristics of pCLE.

resultsThe sensitivity and specificity for HD-WLE were 34.2% and 92.7%, respectively, compared with 68.3% and 87.8%, respectively, for HD-WLE or pCLE (P = .002 and P < .001, respectively). The sensitivity and specificity for HD-WLE or NBI were 45.0% and 88.2%, respectively, compared with 75.8% and 84.2%, respectively, for HD-WLE, NBI, or pCLE (P = .01 and P = .02, respectively). Use of pCLE in conjunction with HD-WLE and NBI enabled the identification of 2 and 1 additional HGD/EC patients compared with HD-WLE and HD-WLE or NBI, respectively, resulting in detection of all HGD/EC patients, although not statistically significant. LIMITATIONS: Academic centers with enriched population.

conclusionspCLE combined with HD-WLE significantly improved the ability to detect neoplasia in BE patients compared with HD-WLE. This may allow better informed decisions to be made for the management and subsequent treatment of BE patients. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT00795184.).

Indexed as

Microscopy, ConfocalAdultAgedAged, 80 and overBarrett EsophagusCarcinomaEsophageal NeoplasmsEsophagoscopyFemaleHumansImage EnhancementLightMaleMiddle AgedPrecancerous ConditionsSensitivity and Specificity

Identifiers

PMID21741642
PMCPMC3629729
OpenAlexW2144805075

What OpenQuestion holds

Textmetadata
LicenceTDM
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.