Submucosal Tumor of Intestine
Conditions
Brief summary
The concept of natural orifice transluminal endoscopic surgery (NOTES) (1) has evolved to endoscopic full thickness resection (EFTR). It represents innovation in technique that allows endoscopists to advance further into the endoscopic surgical space. EFTR has transformed the ability to tackle subepithelial tumors (SETs) and early mucosal neoplasm that are not amenable to classic ESD technique, enhance the staging accuracies for marginal lesions, and even increase the diagnostic capabilities for infiltrative disorders. Thus far, multiple methods have been described to perform EFTR, including nonexposed and exposed techniques, with the closure occuring before resection or after resection, respectively (2). Early comparative studies show no difference between the two methods (3). However, the procedures themselves are limited by the current tools available and by described techniques to achieve resection. Investigators are described here a novel non-exposed technique, with closure before resection, using the Endomina device.
Interventions
DEVICEEndomina
Suturing system with sutures apposition then bulging then cutting
Sponsors
Erasme University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Lesion untreatable with standard technique. 2. Age between 18-65 years; 3. Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study specific procedures such as: clinical assessment, endoscopy, radiography, as well as laboratory investigations; 4. Must be able to understand and be willing to provide written informed consent; 5. Must live within 75 km of the treatment site;
Exclusion criteria
1. Achalasia and any other esophageal motility disorders (for upper GI lesion) 2. Severe esophagitis (for upper GI lesion) 3. Gastro-duodenal ulcer (for upper GI lesion) 4. Severe renal, hepatic, pulmonary disease or cancer; 5. GI stenosis or obstruction; 6. Pregnancy, breastfeeding or willing to become pregnant in the coming 18 months; 7. Anticoagulant therapy; 8. Impending gastric surgery 60 days post intervention (Upper GI); 9. Currently participating in other study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of all Adverse Device Effects | one year from procedure | Safety will be characterized by the incidence of all Adverse Device Effects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| R0 resection | 1 month after resection | R0 resection at histology |
Countries
Belgium
Outcome results
None listed