Randomized Controlled Trial to Compare Hybrid-Argon-Plasma-Coagulation (Hybrid-APC) and Radiofrequencyablation in Treatment of Barrett´s esophagus with Low-Grade Intraepithelial Neoplasia and High-Grade Intraepithelial Neoplasia or After Primary Endoscopic Resection of Early Cancer in the Esophagus.

Not Applicable

Recruiting

Conditions: C15.9
Oesophagus, unspecified

Registration Number: DRKS00013026

Lead Sponsor: Sana Klinikum Offenbach

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 314

Inclusion Criteria

Patients with Barrett´s mucosa after endoscopic resection of all visible lesions. Barrett´s length = 1 cm with maximum of high-grade intraepithelial neoplasia.
Patients without visible lesions after carefully inspection by second endscopy (High -definition endoscopes and chromoendoscopy) and confirmed intraepithelial neoplasia by a second pathologist.

Exclusion Criteria

• Age under 18 years and over 85 years
• Patients unable to give consent
• Pregnancy
• Insufficiant endoscopic therapy after more than 3 endoscopic interventions.
• Patients after radiofrequency ablation, Argon-plasma-coagulation or any other ablativ therapy
• Patient with non-dysplastic Barrett´s esophagus
• Barrett length < 1cm
• Patients with severe esophageal stenosis after endoscopic resection.
• Patients with diagnosis of non currative severe carcinoma
• Patients with coagulation disorder
• Missing written consent

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary target is the complete eradication rate of all neoplasia and Barrett´s epithelium, measured by a neagative follow-up endoscopy with biopsy (histologic and macroscopic response). Follow-up endoscopy is planned after 3-6-12 and 24 months. All patients will recieve invitation for a long-term follow-up after 5 years.

Secondary Outcome Measures

Name	Time	Method
• Number of ablation sessions needed. <br>• Initial (30 days) and late post interventional complications ( Pain, dysphagia, fever, bleeding, stenosis, mortality) and their therapy, particularly stenosis and specialized therapy (Number of dilatations needed). <br>• Barrett´s recurrence after 1 and 2 years after complete eradication and after long term 5 years follow-up.<br>• Operating time<br>• Evaluation for Risk for neoplasia in the neo-Barrett by systematic biopsies during all follow-up endoscopies.<br>• Prospective evaluation of wound healing.