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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00013026

Enrollment

314

Registered

2017-11-28

Start date

2017-11-30

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C15.9

Interventions

Group 1: Hybrid Argon-Plasma-Coaguation with a maximum of 5 sessions per patient Group 2: Radiofrequencyablation with a maximum of 5 sessions per patient

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
• Number of ablation sessions needed. • 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). • Barrett´s recurrence after 1 and 2 years after complete eradication and after long term 5 years follow-up. • Operating time • Evaluation for Risk for neoplasia in the neo-Barrett by systematic biopsies during all follow-up endoscopies. • Prospective evaluation of wound healing.	—

Measure

Time frame

• Number of ablation sessions needed. • 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). • Barrett´s recurrence after 1 and 2 years after complete eradication and after long term 5 years follow-up. • Operating time • Evaluation for Risk for neoplasia in the neo-Barrett by systematic biopsies during all follow-up endoscopies. • Prospective evaluation of wound healing.

—

Countries

Germany

Contacts

Public ContactMate Knabe

Sana Klinikum Offenbach

mate.knabe@sana.de06984053971

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026