Effectiveness, feasibility and safety in the ablation of Barrett`s esophagus by EndoRotor.

Not Applicable

Conditions: C16.9
K22.7
Stomach, unspecified
Barrett oesophagus

Registration Number: DRKS00012925

Lead Sponsor: Sana Klinikum Offenbach

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 40

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

- missing of consent
- Pregnancy
- coagulation disorders (Quick <60%, PTT> 50s, thrombocytes <100,000 / nl)
- therapeutic use of thrombocyte aggregation inhibitors <7 days
- oral anticoagulation without the possibility of a pause

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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 Outcome Measures

Name	Time	Method
Influencing the complication rate by the type of barrette (size, length, pre-treatment), <br>the necessary number of sessions until completion of the ablation.