Oesophageal Disease
Conditions
Keywords
endoscopy, mini invasive
Brief summary
Esophageal diverticulum is a rare disease. Majority comes form the pharyngo-esophageal junction (70 % Zenker's Diverticulum), 10% are mediothoracic and 20% epiphrenic. Zenker's diverticulum is well treated with endoscopy (efficacy around 80%, complications around 5%) (1). For medio or epihrenic diverticulum, the classic treatment is surgery (diverticulectomy with or without anti-reflux surgery) but is associated with 33% morbidity and 9% mortality (2). Recently another technique involving magnet was described (3). Five patients were treated with success. Considering the surgical risk, other techniques need to be evaluated. Using the Endomina device, sutures can be apposed between the foot of the diverticulum and the esophageal lumen. If necessary the bridge between the diverticulum and the esophagus can be cut with needle knife as described in Zenker's diverticulum treatment.
Interventions
DEVICEEndomina
Suturing system then cutting the bridge between the diverticulum and the esophagus.
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 80 Years
Healthy volunteers
No
Inclusion criteria
1. Symptomatic medio or epiphrenic diverticulum. 2. Age between 18-80 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. 2. Severe esophagitis 3. Gastro-duodenal ulcer 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. 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 |
|---|---|---|
| Dysphagia | one year from procedure | Efficacy will be measured by the Dakkak and Bennett score of Dysphagia (Score 0 - no dysphagia to 4 - aphagia) |
Countries
Belgium
Outcome results
None listed