C16.9 K22.7
Conditions
Interventions
Group 1: Prospective pilot study for ablation by EndoRotor, to be performed in 40 patients with Barrett´s esophagus that have an indication for ablation treatment. In some cases several sessions will
Sponsors
Sana Klinikum Offenbach
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: - Consentable - over 18 years - Patients undergoing endoscopic resection of malignant or premalignant neoplasia in the barrett's mucosa for ablation therapy of the remaining non-neoplastic barrett's mucosa
Exclusion criteria
Exclusion criteria: - missing of consent - Pregnancy - coagulation disorders (Quick 50s, thrombocytes <100,000 / nl) - therapeutic use of thrombocyte aggregation inhibitors <7 days - oral anticoagulation without the possibility of a pause
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of the EndoRotor in the ablation therapy of nonmalignant Barrett's mucosa. The complication as well as the side effects rate, such as hemorrhage (major / minor), stenosis development, perforation as well as postinterventional pain are recorded. An endoscopically check is carried out on the first post-intervention day. Furthermore, a Hb control is carried out on the following day. Pain is documented via visual analogue scale on the intervention day as well as on the following days. (Average inpatient stay during an ablation therapy 3-4days). For assessment of stenosis as well as for continuation of the therapy an OGD (Oesophagogastroduodenoscopy) control is performed after 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Influencing the complication rate by the type of barrette (size, length, pre-treatment), the necessary number of sessions until completion of the ablation. | — |
Countries
Germany
Contacts
Public ContactAndrea May
Sana Klinikum Offenbach
Outcome results
None listed