Hybrid APC Argon-Plasma-Coagulation Technique for the Therapy of Barrett's Esophagus With Low-grade and High-grade Neoplasia or After Primary Endoscopical Resection of Premature Neoplasia

Not Applicable

Completed

Conditions: K22.7
Barrett oesophagus

Registration Number: DRKS00006114

Lead Sponsor: Sanaklinikum Offenbach

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 164

Inclusion Criteria

•Patients with secondary neoplastic Barrett's esophagus after successful EMR of visual lesions/ carcinoma whose endotherapy shall be continued. Histologically maximum high grade intraepithelial neoplasia with Barrett's length of = 1 cm und = 10 cm (Prague classification) without visual neoplasia. Any Patient with EMR not longer ago than 6 month and no ablative theray may be included
•Patients without visual lesions, thoroughly endoscoped (HD-endoscopy, acetic acid staining) and by second look approved low grade intraepithelial neoplasia (LGIN), who are supposed to get Hybrid APC as primary therapy
•Patients without visual lesions, thoroughly endoscoped (HD-endoscopy, acetic acid staining) and by second look approved high grade intraepithelial neoplasia (HGIN), who are supposed to get Hybrid APC as primary therapy according to discretion of examiner
•signed Informed Consent

Exclusion Criteria

•proof of Adenocarcinoma with submucosal Infiltration in EMR supplement
•no total ablation of Barrett's mucosa planned
•Patients who are planned to have a total or more than 80% of the Barrett's extension EMR once or more often
•insufficient previous therapy outcome after 3 EMR procedures, e.g. insufficient ER with required re-EMR
•missing re-epithelisation after initial EMR as a sign of disrupted healing process
•status post any ablative therapy, e.g. APC, RFA
•Barrett's esophagus without proven neoplasia or dysplasia
•length of Barrett's esophagus >10 cm (Prague-classification, C-measurement)
•therapy-resistant stenosis (not passable with therapeutic endoscope) after EMR
•Any not curatively treated or not treatable secondary tumors
•Patients with severe general diseases (resisting American Society of Anesthesiologists Classification (ASA) III/IV, dialysis) who will prognostically not profit by the therapy, expectancy of life < 1 year
•Patients with known coagulopathy or anticoagulants other than acetylsalicylic acid
•esophageal varicosis
•pregnancy
•missing Informed Consent

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of complete eradication of Barrett's mucosa or neoplasia, proven by a negative follow-up endoscopy with bioptic controls

Secondary Outcome Measures

Name	Time	Method
-number of ablative sessions<br>-complications, postoperative initial and long-term<br>-success of therapy in relation to patient characteristics<br>-recurrence rates 12 and 24 months after treatment<br>-rate of neoplastic progression