Complete ablation of esophageal epithelium with a balloon-based bipolar electrode: a phased evaluation in the porcine and in the human esophagus.
BACKGROUND
The aim of this study was to evaluate the endoscopic and the histologic effects of a balloon-based bipolar radiofrequency electrode for ablation of porcine and human esophageal epithelium.


METHODS
All procedures were performed with a balloon-based, bipolar radiofrequency system that creates a circumferential, thin-layer epithelial ablation zone within the esophagus. In Phase I, multiple ablations were created in 10 farm swine, followed by acute euthanasia and histologic assessment for completeness of epithelial removal and ablation depth. In Phase II, multiple ablations were created in 19 farm swine, with varying power and energy density, followed by endoscopy at 2 and 4 weeks to assess stricture formation. In Phase III, 3 ablations were created in 12 farm swine, with varying energy density (5, 8, 10, 12, 15, or 20 J/cm 2 ) at 350 W. Animals were euthanized at 48 hours. Histologic examination determined the percentage of epithelium removed and the ablation depth. In Phase IV, 3 patients underwent esophageal epithelial ablation before esophagectomy, creating separate lesions proximal to the tumor. Completeness of epithelial ablation and ablation depth was quantified histologically.


RESULTS
In Phase I, complete removal of esophageal epithelium was achieved at energy density settings of 9.7 to 29.5 J/cm 2 . In Phase II, 9.7 and 10.6 J/cm 2 produced no stricture, whereas more than 20 J/cm 2 produced a stricture in every case. In Phase III, 8-20 J/cm 2 resulted in 100% epithelial ablation. Five and 8 J/cm 2 spared the muscularis mucosae, whereas 10 J/cm 2 caused injury to the muscularis mucosae but preserved the submucosa. In Phase IV, histologic examination demonstrated full-thickness epithelial removal in areas of electrode contact. Ablation extended only to the muscularis mucosae, without injury to submucosa.


CONCLUSIONS
In the porcine and the human esophagus, circumferential, full-thickness ablation of epithelium without direct injury to the submucosa is possible and was well tolerated. In all cases, depth of ablation was linearly related to energy density of treatment.
Ganz
Robert A
RA
Gastroenterology, Abbott-Northwestern Hospital, Chicago Avenue and 26th Street, Minneapolis, MN 55407, USA.
Utley
David S
DS
Stern
Roger A
RA
Jackson
Jerome
J
Batts
Kenneth P
KP
Termin
Paul
P
D000230:Adenocarcinoma / Q000473:pathology / Q000601:surgery*; D000368:Aged; D000818:Animals; D001471:Barrett Esophagus / Q000473:pathology / Q000601:surgery*; D017115:Catheter Ablation / Q000295:instrumentation*; D002404:Catheterization / Q000295:instrumentation*; D016292:Procedural Sedation; D004566:Electrodes; D004867:Equipment Design; D004938:Esophageal Neoplasms / Q000473:pathology / Q000601:surgery*; D016629:Esophagectomy; D020701:Esophagoscopes; D004947:Esophagus / Q000473:pathology; D005240:Feasibility Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011230:Precancerous Conditions / Q000473:pathology / Q000601:surgery*; D012086:Reoperation; D013552:Swine; D013673:Technology Assessment, Biomedical