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

Not Applicable

Terminated

• Conditions: Barrett's Esophagus
• Interventions: Drug: esomeprazole treatment

• Registration Number: NCT00546065
• Lead Sponsor: HSK Wiesbaden

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2007-10-16
• Study First Submitted QC: 2007-10-17
• Study First Posted: 2007-10-18
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-25
• Last Update Posted: 2011-11-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ablation of Barretts with concomitant esomeprazole therapy	esomeprazole treatment	comparison of recurrence-free survival
non ablation	esomeprazole treatment	non ablation only surveillance

Primary Outcome Measures

Name	Time	Method
recurrence-free survival	3 years	recurrence-free survival during 3 years of follow-up

Trial Locations

Locations (1)

HSK Wiesbaden; 🇩🇪 Wiesbaden, Hesse, Germany