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Clinical Trials/NL-OMON33359
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

Academisch Medisch Centrum0 sites20 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

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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