APE-Study: Ablation of Barrett's Mucosa vs. Surveillance Without Ablation in Patients Cured From Barrett's Cancer Combined With Randomization of Esomeprazole vs. Placebo for Symptomatic Reflux Control After Successful Barrett's Ablation

HSK Wiesbaden

Status

Terminated

Conditions

Barrett's Esophagus

Treatments

Drug: esomeprazole treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT00546065

D9612L00088

Details and patient eligibility

About

This is a prospective, randomized, controlled, double-blinded, multi-center trial in a parallel-group design. Aim of the study is the evaluation of tumor-free survival after ablation (by APC, argon plasma coagulation) of Barrett's mucosa plus esomeprazole versus surveillance without ablation in patients cured from Barrett's cancer combined with randomization of esomeprazole vs placebo for symptomatic reflux control after successful ablation of Barrett's mucosa .

There are two hypotheses: (1) Consecutive thermal ablation of metaplastic, non-neoplastic long segments of Barrett's esophagus (>2cm)plus esomeprazole after successful endoscopic therapy of mucosal cancer by means of ER will decrease the incidence of secondary cancer (local recurrence and metachronous cancer) by a minimum of 50% compared to acid suppression alone without ablation within a 5-years follow-up (primary endpoint). (2) After successful ablation of Barrett's esophagus patients need ongoing acid suppression therapy for medical control of their underlying reflux disease (secondary aim of the study).

Duration of the study:

Patient recruitment period: 3 years. Follow-up period: 5 years. Total duration: 8 years. The study is already in the recruitment period.

Enrollment

68 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Endoscopically and histologically complete remission of mucosal Barrett's cancer (endoscopic resection with or without thermal ablation of resection margins)
Initial length of Barrett's segment before cancer therapy > 3 cm (initially long-segment Barrett's esophagus)
Barrett's length after endoscopic therapy of Barrett's cancer > 2 cm
Informed consent of the patient

Exclusion criteria

Attempted ablation therapy before the trial
Treatment duration of early Barrett's cancer > 12 months
Duration between achievement of complete remission and attempted inclusion into the study > 24 months
The Barrett's cancer treated has already been a secondary lesion of earlier Barrett's cancer
Inadequate healing of endoscopic resection (ER) ulcers
No residual Barrett's mucosa observed after pretreatment with ER
No PPI compliance
Relevant comorbidity (e.g., malignancy)
Pregnancy
Age below 18 years
Patient not able to understand study characteristics
No written informed consent available
Allergy against esomeprazole or intolerance of medication ingredients