Evidence map›Paper›PMID 20857372›Full record

Trial reportEndoscopy2010

Endoscopic radiofrequency ablation for Barrett's esophagus: 5-year outcomes from a prospective multicenter trial.

D E Fleischer, B F Overholt, V K Sharma, A Reymunde, M B Kimmey, R Chuttani, K J Chang, R Muthasamy, C J Lightdale, N Santiago and 3 more

3 registry-linked trialsAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Endoscopy, 2010. 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 72 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
72citing papers in PubMed, 2 pooled it
26.7field-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.

NCT00489268 nacompletednot on this map

Micro-Layer Ablation of Barrett's Metaplasia- A Two-Phase, Multi-Center Trial - Extension of Follow-up to 5 Years

TypeinterventionalSponsorCovidien, GI SolutionsRan2003 to 2009Enrolled102ConditionsBarrett EsophagusArmsHALO Ablation System
NCT02793479 unknown statusnot on this mapstarted 2017, after this paper: background citation

National Registry for Radiofrequency Ablation in Patients With Barrett's Esophagus

Typeobservational_patient_registrySponsorMatthias PairederRan2017 to 2021Enrolled500ConditionsBarrett's Esophagus, Radiofrequency Ablation, Gastroesophageal Reflux Disease
NCT03417843 naunknown statusnot on this mapstarted 2018, after this paper: background citation

A Prospective, Open Label Study: Safety and Efficacy of a New Ablation Catheter RFA (Radiofrequency Under EUS) Developed by TAEWOONG Company for the Treatment of Pancreatic Premalignant and Early Malignant Cyctic Lesions.

TypeinterventionalSponsorHaEmek Medical Center, IsraelRan2018 to 2021Enrolled20ConditionsPancreatic Cancer, Pancreatic Neuroendocrine Tumor, Pancreatic Cyst, Pancreatic Cancer StageArmsEUSRA RF electrode
3 · Its place in the literature

Who cites it

72 citing papers in PubMed, 2 syntheses or guidelines pooled it, 212 citations in OpenAlex.

  1. Efficacy and durability of radiofrequency ablation for Barrett's Esophagus: systematic review and meta-analysis.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2013
    Pooled it
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  16. Endoscopic surveillance or ablation for Barrett's esophagus?Translational gastroenterology and hepatology · 2018
    Review
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  18. Review
  19. Article
  20. Quality Indicators in Endoscopic Ablation for Barrett's Esophagus.Current treatment options in gastroenterology · 2017
    Review

12 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 6 institutions in 1 country.

D E FleischerMayo Clinic, 13400 East Shea Boulevard, Scottsdale, AZ 85259, USA. Fleischer.David@mayo.edu
B F Overholt
V K Sharma
A Reymunde
M B Kimmey
R Chuttani
K J Chang
R Muthasamy
C J Lightdale
N Santiago
D K Pleskow
P J Dean
K K Wang
Beth Israel Deaconess Medical Center · USMayo Clinic in Arizona · USUniversity of California, Irvine · USMayo Clinic · USMolecular Design International (United States) · USNewYork–Presbyterian Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND STUDY

aimsThe AIM-II Trial included patients with nondysplastic Barrett's esophagus (NDBE) treated with radiofrequency ablation (RFA). Complete eradication of NDBE (complete response-intestinal metaplasia [CR-IM]) was achieved in 98.4 % of patients at 2.5 years. We report the proportion of patients demonstrating CR-IM at 5-year follow-up. PATIENTS AND

methodsProspective, multicenter US trial (NCT00489268). After endoscopic RFA of NDBE up to 6 cm, patients with CR-IM at 2.5 years were eligible for longer-term follow-up. At 5 years, we obtained four-quadrant biopsies from every 1 cm of the original extent of Barrett's esophagus. All specimens were reviewed by one expert gastrointestinal pathologist, followed by focal RFA and repeat biopsy if NDBE was identified. Primary outcomes were (i) proportion of patients demonstrating CR-IM at 5-year biopsy, and (ii) proportion of patients demonstrating CR-IM at 5-year biopsy or after the single-session focal RFA.

resultsOf 60 eligible patients, 50 consented to participate. Of 1473 esophageal specimens obtained at 5 years 85 % contained lamina propria or deeper tissue (per patient, mean 30 , standard deviation [SD] 13). CR-IM was demonstrated in 92 % (46 / 50) of patients, while 8 % (4 / 50) had focal NDBE; focal RFA converted all these to CR-IM. There were no buried glands, dysplasia, strictures, or serious adverse events. Kaplan-Meier CR-IM survival analysis showed probability of maintaining CR-IM for at least 4 years after first durable CR-IM was 0.91 (95 % confidence interval [CI] 0.77 - 0.97) and mean duration of CR-IM was 4.22 years (standard error [SE] 0.12).

conclusionsIn patients with NDBE treated with RFA, CR-IM was demonstrated in the majority of patients (92 %) at 5-year follow-up, biopsy depth was adequate to detect recurrence, and all failures (4 / 4, 100 %) were converted to CR-IM with single-session focal RFA.

Indexed as

Catheter AblationAdultAgedBarrett EsophagusBiopsyCohort StudiesEsophagusFemaleFollow-Up StudiesHumansKaplan-Meier EstimateMaleMetaplasiaMiddle AgedProspective StudiesRecurrence

Identifiers

PMID20857372
OpenAlexW2316590095

What OpenQuestion holds

Textmetadata
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.