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

This study has been terminated.

( Intermediate results have shown a significant difference in the outcome of ablation and non-ablation patients. Therefore, the study was stopped. )

First Received on October 16, 2007. Last Updated on November 25, 2011 History of Changes

Sponsor:	HSK Wiesbaden
Information provided by (Responsible Party):	HSK Wiesbaden
ClinicalTrials.gov Identifier:	NCT00546065

Purpose

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.

Condition	Intervention
Barrett's Esophagus	Drug: esomeprazole treatment

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Official Title:	APE-Study: Tumor-free Survival After Ablation of Barrett's Mucosa Plus Esomeprazole vs. 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer GERD

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by HSK Wiesbaden:

Primary Outcome Measures:

recurrence-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
recurrence-free survival during 3 years of follow-up

Enrollment:	68
Study Start Date:	August 2006
Study Completion Date:	September 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ablation of Barretts with concomitant esomeprazole therapy comparison of recurrence-free survival	Drug: esomeprazole treatment concomitant esomeprazole treatment
No Intervention: non ablation non ablation only surveillance	Drug: esomeprazole treatment concomitant esomeprazole treatment

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546065

Locations

Germany
HSK Wiesbaden
Wiesbaden, Hesse, Germany, 65199

Sponsors and Collaborators

HSK Wiesbaden

Investigators

Principal Investigator:

Christian Ell, MD PhD

HSK Wiesbaden

More Information

No publications provided

Responsible Party:	HSK Wiesbaden
ClinicalTrials.gov Identifier:	NCT00546065 History of Changes
Other Study ID Numbers:	D9612L00088
Study First Received:	October 16, 2007
Last Updated:	November 25, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by HSK Wiesbaden:

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

Additional relevant MeSH terms:

Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Omeprazole

Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012