EndoRotor ablation of Barrett's esophagus: Safety and Feasibility study

Completed

• Conditions: Dysplasia in Barrett's esophagus; precancerous esophageal mucosa; 10017990

• Registration Number: NL-OMON42962
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1. Written informed consent.
2. Age equal to or above 18 years (adult).
3. Minimum (residual) Barrett*s length of 2 cm and a maximum length of 5 cm (C0-5M2-5 according to the Prague classification)
4. Scheduled Barrett*s ablation for:
a. Histologically proven intestinal metaplasia with either high- or low-grade dysplasia in the absence of any visible lesion,
b. Residual Barrett*s mucosa after complete endoscopic resection (for visible lesions containing HGD or EAC.) (EMR <50% of the circumference)
5. Favorable anatomy (e.g. straight esophagus, no previous anti-reflux procedure) that allows performing endoscopic treatment with the EndoRotor®.

Exclusion Criteria

1. Inability to give informed consent.
2. Age less than 18 years of age.
3. Presence of a visible lesion suspicious of early esophageal cancer or has a high chance of harboring cancer, or biopsy proven cancer.
4. In case of previous EMR: EMR specimen showing deep submucosal invasion (> 500µm), poorly to undifferentiated cancer (G3 or G4), lymphovascular invasion, or positive vertical margins.
5. In case of previous EMR: > 50% circumference.
6. Any prior endoscopic ablation treatment or dilation for esophageal stenosis.
7. Significant esophageal stenosis, preventing the passage of the therapeutic endoscope.
8. Evidence of portal hypertension, esophageal varices, etc.
9. An interval < 6 weeks between EMR and EndoRotor treatment.
10. An interval of > 6 months after the last high resolution endoscopy with biopsies containing low or high grade dysplasia.
11. Unable to undergo endoscopic procedure using sedation analgesics.
12. Anti-coagulant therapy (apart from monotherapy aspirin) that cannot be discontinued prior to the procedure, OR uncorrectable hemostatic disorders.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. To evaluate the safety of EndoRotor® ablation with regard to bleeding,<br /><br>perforation, and post-resection stenosis.<br /><br>2. To evaluate the feasibility of EndoRotor® for the ablation of Barrett*s<br /><br>mucosa: The percentage of endoscopically visible surface regression of<br /><br>Barrett*s epithelium after 3 months post EndoRotor® treatment. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. To evaluate patient discomfort (recorded using the Numeric Rating Scale *<br /><br>grade 1-10), dysphagia-score (recorded using the Ogilvie score), and a variety<br /><br>of other symptoms (recorded using a 7 point Likert scale in a short 30 *day<br /><br>diary post procedure).<br /><br>2. To assess the total time to resect tissue.<br /><br>3. To evaluate the ease of performing the EndoRotor® procedure.</p><br>