NL-OMON33359
Completed
Not Applicable
Single step treatment using radiofrequency ablation and endoscopic resection for Barrett esophagus containing early neoplasia . - Radiofrequency ablation and endoscopic resection: one treatment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Barrett's esophagus
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 20
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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