Evidence map›Paper›PMID 20598302›Full record

Trial reportGastrointestinal endoscopy2010

Biopsy depth after radiofrequency ablation of dysplastic Barrett's esophagus.

Nicholas J Shaheen, Anne F Peery, Bergein F Overholt, Charles J Lightdale, Amitabh Chak, Kenneth K Wang, Robert H Hawes, David E Fleischer, John R Goldblum, AIM Dysplasia Investigators

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Gastrointestinal endoscopy, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00282672 (Ablation of Intestinal Metaplasia Containing Dysplasia), which is not on this map. Cited by 22 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 3 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.

NCT00282672 nacompletednot on this map

Ablation of Intestinal Metaplasia Containing Dysplasia (AIM Dysplasia Trial) A Multi-center, Randomized, Sham-Controlled Trial: Protocol Amendment to Extend Follow-up to 5 Years

TypeinterventionalSponsorMedtronic - MITGRan2006 to 2014Enrolled127ConditionsBarrett EsophagusArmsAblation System plus anti-secretory medication, Sham procedure plus anti-secretory medication
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. ACG Clinical Guideline: Diagnosis and Management of Barrett's Esophagus.The American journal of gastroenterology · 2016
    Guideline
  3. Pooled it
  4. Trial
  5. Article
  6. Article
  7. Natural History of the Post-ablation Esophagus.Digestive diseases and sciences · 2018
    Review
  8. Article
  9. Article
  10. Endoscopic Treatment of High-Grade Dysplasia and Intramucosal Esophageal Adenocarcinoma.Journal of laparoendoscopic & advanced surgical techniques. Part A · 2016
    Review
  11. Review
  12. Emerging Concepts for the Endoscopic Management of Superficial Esophageal Adenocarcinoma.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2016
    Review
  13. Article
  14. Review
  15. Diagnosis and management of Barrett's metaplasia: What's new.World journal of gastrointestinal endoscopy · 2012
    Article
  16. Article
  17. Article
  18. Review
  19. Barrett's esophagus: endoscopic treatments II.Annals of the New York Academy of Sciences · 2011
    Article
  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

10 authors.

Nicholas J ShaheenCenter for Esophageal Diseases and Swallowing, University of North Carolina School of Medicine, Chapel Hill, North Carolina 27599-7080, USA.
Anne F Peery
Bergein F Overholt
Charles J Lightdale
Amitabh Chak
Kenneth K Wang
Robert H Hawes
David E Fleischer
John R Goldblum
AIM Dysplasia Investigators

Funding

PILOT AND FEASIBILITY STUDIESP30DK034987 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI ROBERT S. SANDLER · 1985 to 2026
$30.5M
DIGESTIVE DISEASES EPIDEMIOLOGY TRAINING PROGRAMT32DK007634 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI ROBERT S. SANDLER · 1990 to 2026
$7.4M
NIDDK NIH HHS IH P30 DK034987NIDDK NIH HHS P30 DK034987NIDDK NIH HHS T32 DK007634NIDDK NIH HHS T32 DK 07634
6 · The paper itself

Abstract

backgroundAfter endoscopic radiofrequency ablation (RFA) of dysplastic Barrett's esophagus (BE), endoscopic biopsy samples are obtained to assess response to therapy. Whether these biopsies are of adequate depth to assess efficacy is unknown.

objectiveTo compare the depth of endoscopic biopsy samples after RFA with those of untreated controls and to determine the prevalence of subepithelial structures in endoscopic biopsy fragments.

designSecondary analysis of the AIM Dysplasia Trial, a multicenter, randomized, sham-controlled study.

settingNineteen treatment centers. PATIENTS: Subjects with dysplastic BE, either status post RFA or ablation naïve (sham). MAIN OUTCOME MEASUREMENTS: The proportion of biopsy samples demonstrating subepithelial structures, stratified by tissue type (columnar vs squamous) in sham- and RFA-treated subjects.

resultsA total of 5648 biopsy fragments were analyzed from 113 subjects (78 RFA, 35 sham; mean 50.0 fragments per subject). Most fragments (4653, 82.4%) contained subepithelium. Squamous biopsy samples from RFA and sham subjects demonstrated subepithelium at similar rates (78.4% vs 79.1%, respectively, P = not significant [NS]). Columnar biopsy samples from RFA and sham subjects also included subepithelium at similar rates (99.0% vs 98.8%, respectively, P = NS). Regardless of treatment assignment, more columnar than squamous biopsy samples demonstrated subepithelium (98.8% vs 78.5%, P < .001). LIMITATIONS: Biopsy samples were not individually mounted.

conclusionsIn both squamous and columnar tissue, endoscopic biopsy samples after RFA were as likely to demonstrate subepithelium as untreated controls. Almost 80% of all biopsy samples were adequate to evaluate for subsquamous intestinal metaplasia. The primary determinant of biopsy depth is the type of epithelium that underwent biopsy, with squamous less likely to yield subepithelium than columnar. Biopsy samples after RFA appear to be of adequate depth to assess response to therapy. (Clinical trial registration number NCT00282672.).

Indexed as

EsophagoscopyAdenocarcinomaAgedBarrett EsophagusBiopsyCatheter AblationDisease ProgressionEsophageal NeoplasmsEsophagusFemaleFollow-Up StudiesHumansMaleMetaplasiaMiddle AgedPostoperative Complications

Identifiers

PMID20598302
PMCPMC3093936

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.