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.)
Sponsor:
Information provided by (Responsible Party):
HSK Wiesbaden
ClinicalTrials.gov Identifier:
NCT00546065
First received: October 16, 2007
Last updated: November 25, 2011
Last verified: November 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on August 28, 2014