Improving practicality of radiofrequency ablation for eradication of Barrett's mucosa: A randomized trial comparing two different treatment regimens for focal ablation using the HALO90 System.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24115

Enrollment

Registered

2010-09-03

Start date

2008-10-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Barrett's esophagus

Interventions

Focal endoscopic radiofrequency ablation using the HALO90-catheter of the HALO System: Standard or simplified regimen: Prior to ablation the exact location of islands were registered: Distance to bit

Eligibility

Inclusion criteria

Inclusion criteria: 1. Scheduled HALO90 ablation for BE (with or without neoplasia) after prior circumferential ablation using the HALO360 System for BE with flat low-grade dysplasia (LGD) or high-grade dysplasia (HGD) or for BE (with or without neoplasia) after prior endoscopic resection (ER) for lesions containing HGD or and early cancer; 2. One or more BE islands with a minimum size of 5-mm; 3. Written informed consent. BE islands selection/Inclusion criteria: Maximum size ≤4 adjacent HALO90 applications and <50% of the circumference.

Exclusion criteria

Exclusion criteria: 1. Patients with endoscopically active inflammation in the treatment zone; 2. Esophageal stenosis preventing advancement of the endoscope with the HALO90 catheter. BE islands selection/Exclusion criteria: 1. Prior treatment of the selected islands with HALO90 ablation; 2. Endoscopically visible abnormalities in one of the selected islands; 3. Patients unable to give informed consent.

Design outcomes

Primary

Measure	Time frame
Rate of complete removal of BE islets (completely remove yes/no), as scored by the endoscopist (blinded for the allocation of the islands but nor the location of the islands that were randomized and treated) after 2 months as scored during the endoscopy using a standard case record form.	—

Secondary

Measure	Time frame
1. Percentage of endoscopically visual surface regression of BE epithelium after 2 months as scored by the endoscopist blinded to the treatment regimen during the endoscopy using a standard case record form, by a study monitor; 2. Number of introductions of the ablation device and endoscope as scored during the endoscopy using a standard case record form by a study monitor; 3. Complications as assessed by a telephone interview one or two days after the procedure and by registration using a standard case record form.	—

Measure

Time frame

1. Percentage of endoscopically visual surface regression of BE epithelium after 2 months as scored by the endoscopist blinded to the treatment regimen during the endoscopy using a standard case record form, by a study monitor; 2. Number of introductions of the ablation device and endoscope as scored during the endoscopy using a standard case record form by a study monitor; 3. Complications as assessed by a telephone interview one or two days after the procedure and by registration using a standard case record form.

—

Contacts

Public ContactJ.J.G.H.M. Bergman

Academic Medical Center Bldg. C2-210, Meibergdreef

j.j.bergman@amc.uva.nl+31 (0)20 5669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)