A Feasibility Trial to Evaluate Endoscopic Removal of early esophageal neoplasia using Endoscopic Submucosal Dissection with LumenR Esophageal RetractorTM (LER), a Modified Esophageal Overtube
- Conditions
- early esophageal neoplasiavroege slokdarmkanker
- Registration Number
- NL-OMON25650
- Lead Sponsor
- AMC Amsterdam
- Brief Summary
none
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
To be enrolled in this study, subjects must meet the following entry criteria.
1.Age from 18 to 90 years.
Exclusion Criteria
1.Clear presence of invasion into the proper muscle layer of the esophagus on endoscopic ultrasound.
2.Local lymph node metastasis on EUS with positive fine needle aspiration.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Experienced technical ease/difficulty of the LumenR retractor assisted ESD relative to the anticipated ease/difficulty (by two endoscopist) of removing the lesion with standard ESD. This will be measured using a -5 to +5 visual analogue scale with zero denoting an equal ease/difficulty of the LumenR retractor assisted ESD and standard ESD. <br /><br>2.Difference in duration of time of the estimated time (by two endoscopists experienced in performing ESD) required for standard ESD and the actual time required for resection by LumenR retractor assisted ESD. <br>
- Secondary Outcome Measures
Name Time Method 1.Number of patients with complete en bloc endoscopic resection using LumenR-assisted ESD.<br /><br>2.Number of patients with a histological R0-resection.<br /><br>3.Duration of time required to resect the lesion of interest.<br /><br>4.Rate of acute complications (occurring during the procedure).<br /><br>5.Rate of early complications (occurring <48 hours of the procedure).<br /><br>6.Rate of late complications (occurring >48 hours and <30 days after the procedure).<br /><br>7. Amount of solution used for submucosal injection to lift the target tissue. <br>