Endoscopically treated Barrett-adenocarcinoma with complete remission MedDRA version: 8.1 Level: PT Classification code 10004137 Term: Barrett's oesophagus
Conditions
Interventions
Product Name: Esomeprazol gastro-resistant tablets 40 mg
Product Code: Esomeprazol
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ESOMEPRAZOLE
CAS Number: 119141887
Concentration unit: m
Sponsors
HSK, Dr. Horst Schmidt Kliniken GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Endoscopically (lateral extent) and histologically (basal extent) proven complete remission after endoscopic therapy of a mucosal Barrett-adenocarcinoma (endoscopic resection +/- thermal treatment of resection margins) (complete remission) - Initial length of Barrett-segment prior to therapy of Barrett-carcinoma >3 cm (tongues and circumferential part together) (initial LSBE) - Histologically proven presence of non-neoplastic Barrett-mucosa of at least 2 cm extent (longitudinal or radial extent (no high grade intraepithelial neoplasia or adenocarcinoma in at least 4 biopsies per 2 cm Barrett-segment) (present Barrett-segment >2 cm) - Adult patient and informed consent to repeated endoscopic examinations (diagnostic and therapeutic) as well as to continuous drug therapy with proton pump inhibitors (PPI, esomeprazole) (informed consent) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Previous attempt of ablation of non-neoplastic Barrett-mucosa (irrespective of time and method; not valid with regard to previous administration of ablative methods for the treatment of neoplastic Barrett-mucosa; previous ablation) - Time interval to achieve complete remission of Barrett-carcinoma >12 months (from first to last endoscopic therapy; prolonged therapy phase) - Time interval between achievement of complete remission and enrollment to this trial of more than 24 months (delay between therapy and secondary prophylaxis) - Barrett-carcinoma that is the cause for checking participation in the present trial is a recurrence of a previously known and pre-treated carcinoma (Barrett-carcinoma-recurrence) - History of repeatedly poor or lacking healing of therapeutically induced ulcerations (chronic EMR-ulcer) - No detectable Barrett-mucosa after completion of primary therapy or when complete remission was achieved (no Barrett-mucosa) - Being unwilling or unable to take proton pump inhibitors (PPI, esomeprazole) regularly and for a long time (no PPI-compliance) - Co-morbidity of malignant diseases or life expectancy <1 year - Pregnancy and lactation period (women of childbearing potential must use reliable contraceptive measures during the trial: e.g., hormonal contraceptives, intrauterine device, condoms, abstinence) - Age below 18 years - Inability or doubts with regard to ability of the patient to understand nature, significance, implications and risks of the clinical trial and to take appropriate decisions - Missing signed declaration of consent after appropriate information - Known intolerance to esomeprazole, substituted benzimidazoles or one of the other ingredients of trial medication - Known fructose-intolerance, glucose-galactose-malabsorption or saccharase-isomaltase-deficiency - Increased bleeding risk during therapeutic endoscopic procedures (thrombocytopenia, plasmatic coagulation disorders, history of bleeding tendency, esophageal varices, liver cirrhosis Child-Pugh B/C), renal insufficiency requiring dialysis or other clinically relevant risks according to the investigator’s opinion - Participation in another clinical trial within one month prior to or during the present trial - Previous participation in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that thermal ablation of residual long segments of metaplastic, non-neoplastic Barrett-mucosa (> 2 cm) after successful endoscopic therapy with EMR under concomitant acid suppression with esomeprazole reduces the incidence of secondary neoplasias (local recurrence and metachronic neoplasia) during 5-year follow-up in comparison to acid suppression with esomeprazole alone without thermal ablation (study objective secondary prevention; primary study end point: secondary neoplasia during 5-year follow-up; secondary study end points: completion of 5-year follow-up or premature termination of the study).;Secondary Objective: To demonstrate that patients after successful thermal ablation require continuation of acid suppressive therapy with proton pump inhibitors for symptomatic control of the underlying reflux disease (study objective: control of reflux symptoms; primary study end point: occurrence of reflux symptoms under double-blind medication of esomeprazole vs. placebo; secondary study end points: completion of 5-year follow-up or premature termination of the study).;Primary end point(s): (1) primary end point of main study objective secondary prevention: incidence of secondary neoplasias (Barrett-adenocarcinoma and high-grade neoplasia) during follow-up and time of occurrence (secondary end points: individual completion of 5-year follow-up without secondary neoplasia, premature termination of the study, death) (2) primary end point of the secondary study objective Barrett-ablation: feasibility, completeness and safety of Barrett-ablation with APC (secondary end points: failure of APC-ablation >90 % of Barrett-segment, recurrence of non-neoplastic Barrett-esophagus, individual completion of 5-year follow-up without secondary neoplasia, premature termination of the study, death) (3) primary end point of the secondary study objective reflux control: symptomatic or endoscopic recurrence of reflux disease after successful thermal ablatio | — |
Countries
Germany
Outcome results
None listed