A Pilot Trial of Endoscopic Radiofrequency Ablation for the Eradication of Esophageal Squamous Intraepithelial Neoplasia and Early Squamous Cell Carcinoma Limited to the Mucosa
Frederike G. Van Vilsteren*1, Lorenza Alvarez Herrero2,1, Roos E. Pouw1, Carine Sondermeijer1, Fiebo J. Ten Kate3, Mark I. Van Berge Henegouwen4, Bas L. Weusten2,1, Jacques Bergman1
1Gastroenterology and Hepatology, Amsterdam Medical Center, Amsterdam, Netherlands; 2Gastroenterology and Hepatology, Sint Antonius Hospital, Nieuwegein, Netherlands; 3Pathology, Amsterdam Medical Center, Amsterdam, Netherlands; 4Surgery, Amsterdam Medical Center, Amsterdam, Netherlands
BACKGROUND: Esophagectomy is indicated for esophageal squamous cell cancer (ESCC) involving the muscularis mucosae (T1m3) or deeper, due the elevated risk for lymphatic invasion associated with this and later stages. For the earlier lesions of high-grade intraepithelial neoplasia (HGIN) and ESCC (T1m2), however, endoscopic therapy may be a preferred approach due to a lower morbidity and mortality risk compared to surgery. Endoscopic resection (ER) and radiofrequency ablation (RFA) are safe and highly effective for dysplasia and early cancer in Barrett’s esophagus, but less is known about their utility in squamous HGIN and early ESCC. AIMS: Evaluate the feasibility of ER and RFA for esophageal squamous HGIN and early ESCC (T1m2). METHODS: Patients were enrolled in this prospective, ethics committee approved trial and all signed informed consent. High-resolution chromoendoscopy (Lugol’s) of the esophagus demonstrated ≥1 unstained lesion (USL) with HGIN or ESCC (T1m2) on biopsy or ER. Tattoos were placed 1 cm proximal and distal to the USL-bearing portion of the esophagus, defined as the treatment area (TA). Focal ER was used to remove visible lesions (type 0-IIa or 0-IIc) for staging and to render the mucosa flat prior to RFA. EUS/CT ruled out metastatic disease. Primary circumferential RFA was applied if TA ≥4 cm, while focal RFA was applied if TA <4 cm. Chromoendoscopy was repeated every 3 months with biopsy and focal RFA of residual USLs until all biopsies were negative for squamous neoplasia (CR-Neo). After CR-Neo, chromoendoscopy was repeated at 2 and 6 months and then annually with biopsy of TA (2 specimens/2 cm). RESULTS: Twelve patients (6 male, median age 67 (IQR 58-73), 9 HGIN/3 ESCC) were enrolled. Nine patients had prior ER. Median length of TA was 5 cm (IQR 4-6), median extent of USLs was 50% of circumference (IQR 25-75%). All 12 patients achieved CR-Neo after median 1 RFA (IQR 1-2). During RFA, there were 2 mucosal lacerations (1 at ER scar) and 1 intramural hematoma, none requiring therapy. One patient developed stenosis after ER/RFA, dilation of which resulted in perforation managed with a covered stent. Median follow-up is now 19 months (IQR 13-24) and all patients remain CR-Neo. CONCLUSIONS: In this single center, pilot trial of ER and RFA for esophageal squamous HGIN and ESCC (T1m2), we achieved a CR-Neo in all patients after 1 or 2 ablations. No recurrences have occurred 19 months after achieving CR-Neo. While these results are encouraging, larger studies in homogeneous patient populations are needed to address the role of endoscopic therapy for HGIN and early ESCC.
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