A randomized trial comparing the ER-cap technique and the multiband mucosectomy technique for piecemeal endoscopic resection of early Barrett neoplasia.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25855

Enrollment

Registered

2008-09-05

Start date

2005-04-01

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 esophagus

Interventions

Patients are randomized to undergo endoscopic resection using either the standard ER-cap technique, or the newer multiband mucosectomy technique.

Eligibility

Inclusion criteria

Inclusion criteria: 1. BE with biopsy proven high-grade dysplasia (HGD) and/or early cancer (EC); 2. In case of visible lesions: type 0-IIa, 0-IIb, 0-IIc, or combinations of these types; 3. No suspicion of submucosal invasion on endoscopy or endosonography; 4. No signs of lymph node and/or distant metastases on endosonography and CT-scanning of thorax and abdomen; 5. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Lesion with suspicion on submucosal invasion; 2. Unable to give informed consent.

Design outcomes

Primary

Measure	Time frame
- Rate of radically resected lesions; - Number and severity of complications.	—

Secondary

Measure	Time frame
- Time per procedure; - Number of resected pieces per procedure, - Costs of disposables per procedure; - Maximum diameter of resected specimens; - Maximum thickness of submucosa in resected specimens.	—

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)