NCT02047305

Radiofrequency Ablation for Patients With Esophageal Squamous Cell Neoplasia

A Single-center Trial of Endoscopic Radiofrequency Ablation of Moderate and High-grade Intra-epithelial Squamous Neoplasia and Early Flat-type Squamous Cell Carcinoma Using the HALO Ablation System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Covidien, GI Solutions · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Patients with MGIN, HGIN or flat-type early SCCA of the esophagus will be treated on 3 month intervals with Radiofrequency Ablation (RFA) until complete eradication (CR: no MGIN or worse in the biopsies) will be achieved. All patients will undergo an endoscopy at 12 months after baseline, and the patients with CR will undergo annual endoscopy with biopsies for 5 years.

Detailed description

A patient population with a histopathological diagnosis of moderate-grade intra-epithelial neoplasia (MGIN), high-grade intra-epithelial neoplasia (HGIN) and/or early flat-type SCCA of the esophagus, in lesions measuring 3 to 12cm in length, will be treated with radiofrequency ablation (RFA) using the HALO ablation system. Additional RFA sessions will be performed on 3 month intervals until complete response (CR; no MGIN or worse in biopsies) will be achieved. All patients will then undergo an endoscopy at 12 months after baseline. Patients with CR at 12 months will be followed-up for 5 years with annual endoscopy and biopsies, and additional treatment if necessary. Patients with no CR at 12 months are considered failures.

Conditions

• ESOPHAGEAL SQUAMOUS CELL CARCINOMA

Interventions

Type	Name	Description
DEVICE	Radiofrequency Ablation	Patients with a histopathological diagnosis of moderate-grade intra-epithelial neoplasia (MGIN), high-grade intra-epithelial neoplasia (HGIN) and/or early flat-type SCCA of the esophagus, are treated with radiofrequency ablation, with repeat endoscopy and follow-up treatment at 3 month intervals.

Timeline

• Start date: 2009-01-01
• Primary completion: 2016-08-01
• Completion: 2016-11-01
• First posted: 2014-01-28
• Last updated: 2020-05-21
• Results posted: 2020-05-21

Locations

1 site across 1 country: China