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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

NCT ID: NCT00546065

Last Updated: 2011-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2010-09-30

Brief Summary

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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

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Conditions

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Barrett's Esophagus

Keywords

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Barrett's esophagus ablation esomeprazole Barrett's cancer Ablation of Barrett's esophagus Surveillance of Barrett's esophagus after endoscopic resection of Barrett's cancer Recurrence of Barrett's cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ablation of Barretts with concomitant esomeprazole therapy

comparison of recurrence-free survival

Group Type OTHER

esomeprazole treatment

Intervention Type DRUG

concomitant esomeprazole treatment

non ablation

non ablation only surveillance

Group Type NO_INTERVENTION

esomeprazole treatment

Intervention Type DRUG

concomitant esomeprazole treatment

Interventions

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esomeprazole treatment

concomitant esomeprazole treatment

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HSK Wiesbaden

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian Ell, MD PhD

Role: PRINCIPAL_INVESTIGATOR

HSK Wiesbaden

Locations

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HSK Wiesbaden

Wiesbaden, Hesse, Germany

Site Status

Countries

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Germany

Other Identifiers

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D9612L00088

Identifier Type: -

Identifier Source: org_study_id