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Improving practicality of radiofrequency ablation for eradication of Barrett's mucosa: A randomized trial comparing three different treatment regimens for circumferential ablation using the HALO360 System.

Improving practicality of radiofrequency ablation for eradication of Barrett's mucosa: A randomized trial comparing three different treatment regimens for circumferential ablation using the HALO360 System.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21516
Enrollment
60
Registered
2010-09-03
Start date
2008-12-01
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

Circumferential balloon-based endoscopic radiofrequency ablation using the HALO system for Barrett's early neoplasia. These treatment sessions take approximally 30-60 minutes. Treatment protocol: HAL

Sponsors

AMC Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Scheduled HALO360 ablation 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. Review of histopathology specimens by a local expert pathologist; 3. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. In case of prior ER: A specimen showing carcinoma with positive vertical resection margins, deep submucosal invasion (≥ T1sm2), poorly or undifferentiated cancer (G3 or G4), or lymphatic/vascular invasion; 2. Patients unable to give informed consent.

Design outcomes

Primary

MeasureTime frame
Percentage of endoscopically visual surface regression of BE epithelium at 3 months as scored by two endoscopists blinded to the treatment regimen by using endoscopic images of the Barrett's esophagus prior to and 3 months after the the first treatment session (e.g. 80% of the Barrett's epithelium in regression). And, by using standardized case record forms on which the size and aspect of the Barrett's esophagis prior to and after the first treatment session are registered.—

Secondary

MeasureTime frame
1. Duration of the procedure (registered on the case record form); 2. Amount and type of sedative medication necessary (registered on the case record form); 3. Number of introductions of the ablation device and endoscope (registered on the case record form); 4. Complications (prospectively registered in the 3months interval after treatment using case record forms); 5. Patient's discomfort after HALO360 treatment (using a standardized questionnaire).—

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)