Outcomes from a prospective trial of endoscopic radiofrequency ablation of early squamous cell neoplasia of the esophagus

Abstract

Background: Radiofrequency ablation (RFA) is safe and effective for eradicating neoplasia in Barrett's esophagus.

Objective: To evaluate RFA for eradicating early esophageal squamous cell neoplasia (ESCN) defined as moderate-grade squamous intraepithelial neoplasia (MGIN) and high-grade squamous intraepithelial neoplasia (HGIN) and early flat-type esophageal squamous cell carcinoma (ESCC).

Design: Prospective cohort study.

Setting: Tertiary referral center.

Patients: Esophageal unstained lesions (USLs) were identified using Lugol's chromoendoscopy. Inclusion criteria were at least 1 flat (type 0-IIb) USL 3 cm or larger, USL-bearing esophagus 12 cm or less, and a consensus diagnosis of MGIN, HGIN, or ESCC by 2 expert GI pathologists. Exclusion criteria were previous endoscopic resection or ablation, stricture, or any nonflat mucosa.

Interventions: Circumferential RFA creating a continuous treatment area (TA) including all USLs. At 3-month intervals thereafter, chromoendoscopy with biopsies followed by focal RFA of USLs, if present.

Main outcome measurements: Complete response (CR) at 12 months defined as absence of MGIN, HGIN, or ESCC in the TA, CR after 1 RFA session, neoplastic progression from baseline, and adverse events.

Results: Twenty-nine patients (14 male, mean age 60.3 years) with MGIN (n = 18), HGIN (n = 10), or ESCC (n = 1) participated. Mean USL length was 6.2 cm (TA 8.2 cm). At 3 months after 1 RFA session, 86% of patients (25/29) had a CR. At 12 months, 97% of patients (28/29) had a CR. There was no neoplastic progression. There were 4 strictures, all dilated to resolution.

Limitations: Single-center study with limited number of patients.

Conclusions: In patients with early ESCN (MGIN, HGIN, flat-type ESCC), RFA was associated with a high rate of histological complete response (97% of patients), no neoplastic progression, and an acceptable adverse event profile.

Conflict of interest statement

Competing interests

Grant support: BÂRRX Medical, Sunnyvale, CA, USA.

Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Figures

Figure 1

After enrollment, patients underwent primary circumferential radiofrequency ablation (RFA) of the treatment area (TA). Patients returned at 3-month intervals for endoscopy with Lugol’s to identify residual USLs. Flow diagram depicts decision tree at each visit based upon endoscopic findings and subsequent histology results. Once a patient demonstrated a histological complete response (CR) defined as absence of MGIN, HGIN and ESCC in all biopsies obtained at a follow-up visit, they were released to the 12-month primary endpoint endoscopy visit.

Figure 2

Circumferential and focal radiofrequency ablation (RFA) of a 5-cm long flat-type early squamous cell neoplasia with high-grade intraepithelial neoplasia (HGIN). Patient achieved complete response (absence of MGIN, HGIN and ESCC in the treatment area) at 12-month primary outcome. A. Pre-treatment white light endoscopy image showing a more reddish colored area at the lower half of the image; B. Corresponding image with narrow band imaging; C. Corresponding image with Lugol’s chromoendoscopy demonstrating a flat type unstained lesion, biopsies showed HGIN; D. Circumferential ablation catheter placed in the esophagus prior to the first ablation pass; E. Appearance of the mucosa after first circumferential ablation pass and after cleaning the ablation zone; F. Circumferential ablation catheter placed in the esophagus prior to the second ablation pass; G. 3-month visit. White light endoscopy image showing the treatment area; H. Corresponding image with Lugol’s chromoendoscopy demonstrating an unstained lesion at 5:00; I. Appearance of the mucosa immediately after focal ablation of the unstained lesion, the ablation catheter can be seen at the top of the endoscopic image; J, K, L. 12-month primary endpoint visit. White light endoscopy and Lugol’s HR chromoendoscopy images demonstrate no evidence of residual squamous neoplasia. Biopsies confirmed complete response.

Figure 3

(a–b). Patient-reported 14-day diary scores after: a) circumferential RFA, and b) focal RFA. Visual analog scale (0–100) with “0” representing no symptoms and “100” representing severe symptoms.

Figure 3

(a–b). Patient-reported 14-day diary scores after: a) circumferential RFA, and b) focal RFA. Visual analog scale (0–100) with “0” representing no symptoms and “100” representing severe symptoms.