Endoscopic radiofrequency ablation for early esophageal squamous cell neoplasia: report of safety and effectiveness from a large prospective trial

Abstract

Background and study aims: Endoscopic radiofrequency ablation (RFA) is an established therapy for Barrett's esophagus. Preliminary reports, limited by low patient numbers, also suggest a possible role for RFA in early esophageal squamous cell neoplasia (ESCN). The aim of this study was to evaluate the safety and effectiveness of RFA for early ESCN (moderate/high grade intraepithelial neoplasia [MGIN/HGIN] and early flat-type esophageal squamous cell carcinoma [ESCC]).

Patients and methods: This prospective cohort study included patients with at least one flat (type 0-IIb) unstained lesion (USL) on Lugol's chromoendoscopy and a consensus diagnosis of MGIN, HGIN, or early ESCC. RFA was used at baseline to treat all USLs, and then biopsy (and focal RFA if USL persisted) was performed every 3 months until all biopsies were negative for MGIN, HGIN, and ESCC. The main outcome measurements were complete response at 3 and 12 months (absence of MGIN, HGIN, and ESCC), neoplastic progression, and adverse events.

Results: A total of 96 patients participated (MGIN 45, HGIN 42, early ESCC 9). At 3 and 12 months, 73 % (70/96) and 84 % (81/96), respectively, showed a complete response. Two patients (2 %) progressed (MGIN to HGIN; HGIN to T1m2 ESCC); both were treated endoscopically and achieved complete response. Stricture occurred in 20 patients (21 %), all after circumferential RFA. Lugol's + RFA 12 J/cm(2) (single application, no cleaning) was the favored baseline circumferential RFA technique (82 % 12-month complete response [14/17], 6 % stricture [6/17]).

Conclusion: In patients with early ESCN, RFA was associated with a high complete response rate and an acceptable safety profile.

© Georg Thieme Verlag KG Stuttgart · New York.

Figures

Figure 1

Representative endoscopic images of the four stain codes used to categorize tissue appearance after application of 1.25% Lugol’s iodine stain. Designation of stain codes 1, 2 or 3 qualified a lesion as unstained. A. Unstained area (stain code 1) B. Mosaic staining-intermixed stained and unstained areas (stain code 2) C. Lightly stained area (stain code 3) D. Completely stained (stain code 4)

Figure 2

Circumferential and focal radiofrequency ablation of a 3-cm long flat-type early squamous cell neoplasia with high-grade intraepithelial neoplasia, treated with Lugol’s-10J/cm2-10J/cm2-no cleaning between ablation passes (circumferential technique Group D). The patient achieved a complete response (absence of moderate-grade intraepithelial neoplasia, high-grade intraepithelial neoplasia, and esophageal squamous cell carcinoma in the treatment area) at the 12-month primary outcome. A. Photomicrograph of a pre-treatment esophageal biopsy specimen demonstrating HGIN (hematoxylin and eosin [H&E]; original magnification × 200). B. Pretreatment white-light endoscopy image showing a reddish colored area from 4 o’clock to 7 o’clock. C. Corresponding image with Lugol’s chromoendoscopy demonstrating a flat-type unstained lesion; biopsy samples showed HGIN. D. Circumferential ablation catheter placed in the esophagus before the first ablation pass. E. Appearance of the mucosa after the first circumferential ablation pass. F. 3-month visit. White-light endoscopy image showing the treatment area. G. Corresponding image with Lugol’s chromoendoscopy demonstrating an unstained lesion at 8 o’clock. H. 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. I–J.12-month primary endpoint visit. White-light endoscopy and Lugol’s high-resolution chromoendoscopy images demonstrate no evidence of residual squamous neoplasia. Biopsies confirmed complete response.

Figure 2

Circumferential and focal radiofrequency ablation of a 3-cm long flat-type early squamous cell neoplasia with high-grade intraepithelial neoplasia, treated with Lugol’s-10J/cm2-10J/cm2-no cleaning between ablation passes (circumferential technique Group D). The patient achieved a complete response (absence of moderate-grade intraepithelial neoplasia, high-grade intraepithelial neoplasia, and esophageal squamous cell carcinoma in the treatment area) at the 12-month primary outcome. A. Photomicrograph of a pre-treatment esophageal biopsy specimen demonstrating HGIN (hematoxylin and eosin [H&E]; original magnification × 200). B. Pretreatment white-light endoscopy image showing a reddish colored area from 4 o’clock to 7 o’clock. C. Corresponding image with Lugol’s chromoendoscopy demonstrating a flat-type unstained lesion; biopsy samples showed HGIN. D. Circumferential ablation catheter placed in the esophagus before the first ablation pass. E. Appearance of the mucosa after the first circumferential ablation pass. F. 3-month visit. White-light endoscopy image showing the treatment area. G. Corresponding image with Lugol’s chromoendoscopy demonstrating an unstained lesion at 8 o’clock. H. 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. I–J.12-month primary endpoint visit. White-light endoscopy and Lugol’s high-resolution chromoendoscopy images demonstrate no evidence of residual squamous neoplasia. Biopsies confirmed complete response.

Figure 2

Circumferential and focal radiofrequency ablation of a 3-cm long flat-type early squamous cell neoplasia with high-grade intraepithelial neoplasia, treated with Lugol’s-10J/cm2-10J/cm2-no cleaning between ablation passes (circumferential technique Group D). The patient achieved a complete response (absence of moderate-grade intraepithelial neoplasia, high-grade intraepithelial neoplasia, and esophageal squamous cell carcinoma in the treatment area) at the 12-month primary outcome. A. Photomicrograph of a pre-treatment esophageal biopsy specimen demonstrating HGIN (hematoxylin and eosin [H&E]; original magnification × 200). B. Pretreatment white-light endoscopy image showing a reddish colored area from 4 o’clock to 7 o’clock. C. Corresponding image with Lugol’s chromoendoscopy demonstrating a flat-type unstained lesion; biopsy samples showed HGIN. D. Circumferential ablation catheter placed in the esophagus before the first ablation pass. E. Appearance of the mucosa after the first circumferential ablation pass. F. 3-month visit. White-light endoscopy image showing the treatment area. G. Corresponding image with Lugol’s chromoendoscopy demonstrating an unstained lesion at 8 o’clock. H. 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. I–J.12-month primary endpoint visit. White-light endoscopy and Lugol’s high-resolution chromoendoscopy images demonstrate no evidence of residual squamous neoplasia. Biopsies confirmed complete response.