Evidence map›Paper›PMID 25980753›Full record

Trial reportGastroenterology2015

Low-Cost High-Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia: An International Trial.

Marion-Anna Protano, Hong Xu, Guiqi Wang, Alexandros D Polydorides, Sanford M Dawsey, Junsheng Cui, Liyan Xue, Fan Zhang, Timothy Quang, Mark C Pierce and 13 more

Abstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Gastroenterology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing 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

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

  1. Pooled it
  2. Trial
  3. Diagnosing Cervical Neoplasia in Rural Brazil Using a Mobile Van Equipped withCancer prevention research (Philadelphia, Pa.) · 2018
    Trial
  4. Article
  5. Article
  6. 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
  7. Article
  8. Article
  9. Article
  10. Review
  11. Esophageal cancer: Epidemiology, risk factors and screening.Chinese journal of cancer research = Chung-kuo yen cheng yen chiu · 2021
    Article
  12. Review
  13. Article
  14. Article
  15. Review
  16. Article
  17. Review
  18. Review
  19. Review
  20. 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

23 authors.

Marion-Anna Protano *Division of Gastroenterology, The Mount Sinai Medical Center, New York, NY.
Hong Xu *Department of Endoscopy, The First Hospital of Jilin University, Changchun, Jilin, China.
Guiqi Wang *Department of Endoscopy, Cancer Institute and Hospital, The Chinese Academy of Medical Sciences, Beijing, China.
Alexandros D PolydoridesDepartment of Pathology, The Mount Sinai Medical Center, New York, NY.
Sanford M DawseyDivision of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD.
Junsheng CuiDepartment of Pathology, The First Hospital of Jilin University, Changchun, Jilin, China.
Liyan XueDepartment of Pathology, Cancer Institute and Hospital, The Chinese Academy of Medical Sciences, Beijing, China.
Fan ZhangDepartment of Endoscopy, The First Hospital of Jilin University, Changchun, Jilin, China.
Timothy QuangDepartment of Bioengineering, Rice University, Houston, TX.
Mark C PierceBiomedical Engineering, Rutgers University, Piscataway, NJ.
Dongsuk ShinDepartment of Bioengineering, Rice University, Houston, TX.
Richard A SchwarzDepartment of Bioengineering, Rice University, Houston, TX.
Manoop S BhutaniDepartment of Gastroenterology, Hepatology and Nutrition, The University of Texas MD Anderson Cancer Center, Houston, TX.
Michelle LeeDivision of Gastroenterology, The Mount Sinai Medical Center, New York, NY.
Neil ParikhDivision of Digestive Diseases, Yale University, New Haven, CT.
Chin HurGI Unit & Institute for Technology Assessment, Massachusetts General Hospital, Boston, MA.
Weiran XuDepartment of Endoscopy, The First Hospital of Jilin University, Changchun, Jilin, China.
Erin MoshierDepartment of Preventative Medicine, The Mount Sinai Medical Center, New York, NY.
James GodboldDepartment of Preventative Medicine, The Mount Sinai Medical Center, New York, NY.
Josephine MitchamDivision of Gastroenterology, The Mount Sinai Medical Center, New York, NY.
Courtney HudsonDivision of Gastroenterology, The Mount Sinai Medical Center, New York, NY.
Rebecca R Richards-Kortum *Department of Bioengineering, Rice University, Houston, TX.
Sharmila Anandasabapathy *Division of Gastroenterology, The Mount Sinai Medical Center, New York, NY.

Funding

Upper Gastrointestinal Cancer StudiesZIACP000185 · NCI · DIVISION OF CANCER EPIDEMIOLOGY AND GENETICS · PI ABNET, CHRISTIAN · 2009 to 2025
$25.6M
High Resolution Microendoscopy for the Management of Esophageal NeoplasiaR01CA181275 · NCI · BAYLOR COLLEGE OF MEDICINE · PI Sharmila Anandasabapathy, Amy L McGuire · 2014 to 2026
$6.3M
CLINICAL/IMMUNOLOGIC/GENETIC ANALYSES OF AUTOIMMUNE LYMPHOPROLIFERATIVE SYNDROMEZ01AI000732 · NIAID · NIAID EXTRAMURAL ACTIVITIES · PI RAO, VEMULKONDA · 1995 to 2008
$1.1M
High Resolution Microendoscopy for the Detection of Esophageal NeoplasiaR21CA156704 · NCI · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI ANANDASABAPATHY, SHARMILA, RICHARDS-KORTUM, REBECCA R. · 2011 to 2012
$697k
NCI NIH HHS R01 CA181275NCI NIH HHS R21 CA156704
6 · The paper itself

Abstract

BACKGROUND &

aimsEsophageal squamous cell neoplasia has a high mortality rate as a result of late detection. In high-risk regions such as China, screening is performed by Lugol's chromoendoscopy (LCE). LCE has low specificity, resulting in unnecessary tissue biopsy with a subsequent increase in procedure cost and risk. The purpose of this study was to evaluate the accuracy of a novel, low-cost, high-resolution microendoscope (HRME) as an adjunct to LCE.

methodsIn this prospective trial, 147 consecutive high-risk patients were enrolled from 2 US and 2 Chinese tertiary centers. Three expert and 4 novice endoscopists performed white-light endoscopy followed by LCE and HRME. All optical images were compared with the gold standard of histopathology.

resultsBy using a per-biopsy analysis, the sensitivity of LCE vs LCE + HRME was 96% vs 91% (P = .0832), specificity was 48% vs 88% (P < .001), positive predictive value was 22% vs 45% (P < .0001), negative predictive value was 98% vs 98% (P = .3551), and overall accuracy was 57% vs 90% (P < .001), respectively. By using a per-patient analysis, the sensitivity of LCE vs LCE + HRME was 100% vs 95% (P = .16), specificity was 29% vs 79% (P < .001), positive predictive value was 32% vs 60%, 100% vs 98%, and accuracy was 47% vs 83% (P < .001). With the use of HRME, 136 biopsies (60%; 95% confidence interval, 53%-66%) could have been spared, and 55 patients (48%; 95% confidence interval, 38%-57%) could have been spared any biopsy.

conclusionsIn this trial, HRME improved the accuracy of LCE for esophageal squamous cell neoplasia screening and surveillance. HRME may be a cost-effective optical biopsy adjunct to LCE, potentially reducing unnecessary biopsies and facilitating real-time decision making in globally underserved regions. ClinicalTrials.gov, NCT 01384708.

Indexed as

AdultAgedAged, 80 and overBiopsyChinaEarly Detection of CancerEsophageal NeoplasmsEsophagoscopyFemaleHumansIodidesMaleMiddle AgedNeoplasms, Squamous CellOptical ImagingPrecancerous ConditionsIodidesLugol's solutionEarly Detection of CancerEndoscopyEsophageal Neoplasm

Identifiers

PMID25980753
PMCPMC4547689

What OpenQuestion holds

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Registered trials

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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.