Endoscopic mucosal Resection versus Endoscopic subMucosal dissection fOr removal of Visible lesions in Barrett*s Esophagus with early neoplasia: a randomized controlled trial

Recruiting

Conditions: Barrett esophagus
esophageal neoplasia
10017991

Registration Number: NL-OMON51866

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 84

Inclusion Criteria

- Patients age: >= 18 years
- Willingness to undergo both EMR or ESD
- Ability to provide written, informed consent (approved by IRB) and understand
the responsibilities of trial participation
- BE with a single visible lesion with absence of signs of submucosal invasion
on endoscopy, after evaluation by the adjudication committee.
- Minimum diameter of the lesion >=15mm (in either direction)

Exclusion Criteria

- Patients with visible lesions with suspicion of submucosal invasion bases on
assessment of the adjudication committee
- History of esophageal surgery other than fundoplication
- History of esophageal ablation therapy or endoscopic resection
- Multiple visible lesions in the BE segment at baseline
- Uncontrolled coagulopathy with INR >2.0, thrombocytopenia with platelet
counts < 50,000
- Subject has a known history of unresolved drug or alcohol dependency that
would limit ability to comprehend or follow instructions related to informed
consent, post-treatment in-structions, or follow-up guidelines
- Life expectancy <2 years

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is the proportion of patients with no evidence of residual or<br /><br>local recurrent neoplasia during 12 months follow-up after baseline.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Incidence of perforation<br /><br>- Incidence of post-procedural bleeding<br /><br>- Incidence of esophageal stenosis<br /><br>- Procedure times<br /><br>- Proportion of patients with endoscopically radical resection<br /><br>- Cost-effectiveness<br /><br>- Total number of ER endoscopies per patient<br /><br>- Proportion of patients with (progression to) high-risk EAC<br /><br>- Proportion of patients in whom additional non-endoscopic therapy is required </p><br>