Single step treatment using radiofrequency ablation and endoscopic resection for Barrett esophagus containing early neoplasia .

Completed

Conditions: Barrett's esophagus
early cancer
10017990

Registration Number: NL-OMON33359

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

- Age 18-85 years;
- Minimum circumferential extent of Barrett's of 2cm prior to treatment
- Endoscopic visible abnormality of type 0-I,0-IIa, 0-IIc or a combination therof.
- Biopsy proven High grade dysplasia (HGD) or Early cancer (EC) on two seperate endoscopic sampling procedures.
- Written informed consent

Exclusion Criteria

1. Barrett's extent of >12cm
2. Any prior endoscopic treatment for esophageal adenocarcinoma of BE associated neoplasia.
3. Signs of local or distant metastasis on EUS (EUS is obligatory).
4. Signs of distant metastasis on CT-scan of thorax and/or abdomen (optional for mucosal lesions).
5. Any of the following findings in any of the ER specimens: G3 or G4 tumor differentiation; lymphatic invasion; infiltration into the submucosa >500µm, a positive deeper resection margin.
6. Endoscopic signs of esophageal varices.
7. Esophageal stenosis not allowing passage of a therapeutic endoscope with an ER-cap.
8. Prior esophageal surgery (except fundoplication).
9. Use of any anticoagulant therapy that can not be discontinued between one week before and 1 week after every treatment session.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. The rate of complete remission of HGD and EC in all biopsies obtained at 12<br /><br>months follow-up.<br /><br>2. The rate of complete remission of BE, defined as the endoscopic absence of<br /><br>columnar lined epithelium upon inspection with NBI and the absence of<br /><br>intestinal metaplasia in all biopsy specimens obtained at 12 months follow-up.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>3. The rate of acute (i.e. < 3 days) complications after therapeutic procedures.<br /><br>4. The rate of late (such as esophageal stenosis) complications occurring<br /><br>during the treatment phase or during follow-up.<br /><br>5. The number of endoscopic therapeutic procedures.<br /><br>6. The frequency, severity, and duration of patient*s symptoms after the first<br /><br>therapeutic session as assessed with standardised questionnaires and patient<br /><br>diaries.</p><br>