early cancer of the esophagus early esophageal neoplasia
Conditions
Interventions
LumenR-assisted endoscopic removal using the ESD-technique
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age from 18 to 90 years. 2. An early esophageal neoplastic lesion with a biopsy-based histological diagnosis of either early Barrett*s neoplasia (i.e. high-grade dysplasia or early adenocarcinoma) or early esophageal squamous neoplasia (i.e. high-grade dysplasia or early squamous carcinoma). 3. The lesion of interest should appear endoscopically resectable according to the discretion of two experienced interventional endoscopists with specific interest in the field of early upper GI neoplasia treatment. 4. The lesion of interest should have a maximum longitudinal extent of 80-mm. 5. The lesion of interest should have a maximum circumferential extent of less than 75%. 6. Patients with early Barrett*s neoplasia should have at least one of the following endoscopic features, which may compromise the radicality of the deeper resection margin and/or the histological assessment of the cancer when using cap-based endoscopic piecemeal resection: a) a bulky intraluminal component; b) lesions with an area suspicious for invasive cancer >20-mm; or c) lesions suspicious for submucosal invasion. 7. Subject is able to understand the risks and benefits of participating in the study and must be willing to sign and date the Informed Consent Form for this study approved by the Institutional Review Board (IRB.)
Exclusion criteria
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. 3. Patients with esophageal narrowing restricting passage of a 20-mm Savary bougie prior to the procedure. 4. Patients with uncorrectable bleeding disorders (INR more than 1.5, platelet count less than 50,000). 5. Patients with esophageal varices 6. Subjects has allergy to materials from which the device is constructed: PVC, Nitinol, Watershed, Polycarbonate, and PTFE. 7. Subjects who received any experimental drug or device within the previous three months. 8. Patients who are not able to sign informed consent, or do not understand the content of the IC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of patients with complete en bloc endoscopic resection using LumenR-assisted ESD. 2. Number of patients with a histological R0-resection. 3. Duration of time required to resect the lesion of interest. 4. Rate of acute complications (occurring during the procedure). 5. Rate of early complications (occurring 48 hours and | — |
Countries
Netherlands
Outcome results
None listed