Evidence map›Paper›PMID 17180281›Full record

Trial reportSurgical endoscopy2007

Endoscopic ablation of intestinal metaplasia containing high-grade dysplasia in esophagectomy patients using a balloon-based ablation system.

C D Smith, P A Bejarano, W S Melvin, M G Patti, R Muthusamy, B J Dunkin

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Surgical endoscopy, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 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

18 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Treatment for Barrett's oesophagus.The Cochrane database of systematic reviews · 2010
    Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Radiofrequency ablation devices.VideoGIE : an official video journal of the American Society for Gastrointestinal Endoscopy · 2017
    Article
  7. Heartburn, Barrett's oesophagus and cancer: implications for primary care.The British journal of general practice : the journal of the Royal College of General Practitioners · 2014
    Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Radiofrequency ablation of Barrett's esophagus.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2010
    Article
  13. Article
  14. Article
  15. Eradication of Barrett esophagus with early neoplasia by radiofrequency ablation, with or without endoscopic resection.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2008
    Article
  16. Management of high-grade dysplasia.Current gastroenterology reports · 2008
    Review
  17. Review
  18. Review
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

6 authors.

C D SmithDepartment of Surgery, Emory University School of Medicine, 1364 Clifton Road, NE, Suite H-122, Atlanta, GA 30322, USA.
P A Bejarano
W S Melvin
M G Patti
R Muthusamy
B J Dunkin

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study aimed to determine the optimal treatment parameters for the ablation of intestinal metaplasia (IM) containing high-grade dysplasia (HGD) using a balloon-based ablation system for patients undergoing esophagectomy.

methodsImmediately before esophagectomy, patients underwent ablation of circumferential segments of the esophagus containing IM-HGD using the HALO360 system. The treatment settings were randomized to 10, 12, or 14 J/cm2 for two, three, or four applications. After esophagectomy, multiple sections from ablation zones were microscopically evaluated. Histologic end points included maximum ablation depth (histologic layer) and complete ablation of all IM-HGD (yes/no).

resultsEight men with a mean age of 57 years (range, 45-71 years) were treated, and 10 treatment zones were created. There were no device-related adverse events. At resection, there was no evidence of a transmural thermal effect. Grossly, ablation zones were clearly demarcated sections of ablated epithelium. The maximum ablation depth was the lamina propria or muscularis mucosae. The highest energy (14 J/cm2, 4 applications) incurred edema in the superficial submucosa, but no submucosa ablation. Complete ablation of IM and HGD occurred in 9 of 10 ablation zones (90%), defined as complete removal of the epithelium with only small foci of "ghost cells" representing nonviable, ablated IM-HGD and demonstrating loss of nuclei and cytoarchitectural derangement. One focal area of viable IM-HGD remained at the margin of one ablation zone (12 J/cm2, 2 applications) because of incomplete overlap.

conclusionComplete ablation of IM-HGD without ablation of submucosa is possible using the HALO360 system. Ablation depth is dose related and limited to the muscularis mucosae. In one patient, small residual foci of IM-HGD at the edge of the ablation zone were attributable to incomplete overlap, which can be avoided. This study, together with nonesophagectomy IM-HGD trials currently underway, will identify the optimal treatment parameters for IM-HGD patients who would otherwise undergo esophagectomy or photodynamic therapy.

Indexed as

AgedBarrett EsophagusBiopsy, NeedleCatheter AblationCatheterizationEquipment DesignEquipment SafetyEsophageal NeoplasmsEsophagectomyFollow-Up StudiesHumansImmunohistochemistryMaleMetaplasiaMiddle AgedNeoplasm Invasiveness

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.