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
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.
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Conditions
Barrett's Esophagus
Intervention
ablation of Barrett's esophagus using argon plasma coagulation (APC), esomeprazole therapy
Location
HSK Wiesbaden
Wiesbaden
Hesse
Germany
65199
Status
Recruiting
Source
HSK Wiesbaden
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00546065
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Argon Plasma Coagulation
A method of tissue ablation and bleeding control that uses argon plasma (ionized argon gas) to deliver a current of thermocoagulating energy to the area of tissue to be coagulated.
Barrett Esophagus
A condition with damage to the lining of the lower ESOPHAGUS resulting from chronic acid reflux (ESOPHAGITIS, REFLUX). Through the process of metaplasia, the squamous cells are replaced by a columnar epithelium with cells resembling those of the INTESTINE or the salmon-pink mucosa of the STOMACH. Barrett's columnar epithelium is a marker for severe reflux and precursor to ADENOCARCINOMA of the esophagus.
Plasma Gases
Ionized gases, consisting of free electrons and ionized atoms or molecules which collectively behave differently than gas, solid, or liquid. Plasma gases are used in biomedical fields in surface modification; biological decontamination; dentistry (e.g., PLASMA ARC DENTAL CURING LIGHTS); and in other treatments (e.g., ARGON PLASMA COAGULATION).
Argon
Argon. A noble gas with the atomic symbol Ar, atomic number 18, and atomic weight 39.948. It is used in fluorescent tubes and wherever an inert atmosphere is desired and nitrogen cannot be used.
Kininogen, High-molecular-weight
A plasma protein, molecular weight of 110 kD, that normally exists in plasma in a 1:1 complex with PREKALLIKREIN. HMWK is split by plasma kallikrein to produce BRADYKININ. The complex is a cofactor in the activation of coagulation factor XII. The product of this reaction, XIIa, in turn activates prekallikrein to KALLIKREINS. (From Stedman, 26th ed)
Clinical Trials
An Open Label pH Comparison of Esomeprazole and Lansoprazole in Barrett's Esophagus Patients
The purpose of the study is to compare the treatment of esomeprazole 40 mg once daily and lansoprazole 30 mg once daily in controlling intragastric pH in Barrett's Esophagus patients
Barrett's Esophagus - 315 - 3 Way Cross-Over
This study looks the intragastric and intraesophageal pH in patients with documented Barrett's esophagus whilst taking esomeprazole 40mg twice daily, esomeprazole 40mg three times daily, e...
Biomarkers in Phototherapy of Barrett's Esophagus
This study is being done to find out if Photodynamic Therapy (treatment with a red light and a drug called photofrin) or Radiofrequency ablation works the same for patients who have biomar...
Acid Reflux and Stromal Fibroblasts in Barrett's Esophagus
Patients with Barrett's Esophagus are known to have excessive distal esophageal acid exposure comparable to patients with erosive esophagitis. A significant proportion of patients with BE...
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of esomeprazole with or without aspirin may prevent esophageal cancer in patients with Barrett e...
PubMed Articles
Endoscopic management of Barrett esophagus.
Endoscopy has a vital role in the diagnosis, screening, surveillance and treatment of Barrett esophagus. Over the past few decades, tremendous advances have been made in endoscopic technology, and the...
BACKGROUND: Endoscopic endoluminal radiofrequency ablation is achieving increasing acceptance as a mode of eliminating Barrett's metaplasia and, thus, reducing the risk of developing esophageal adenoc...
Role of Th-2 cytokines in the development of Barrett's esophagus in rats.
BACKGROUND: Barrett's esophagus is characterized by a distinct Th-2-predominant cytokine profile, unlike the pro-inflammatory nature of reflux esophagitis. The aim of this study was to examine the rol...
Relationship between Kyphosis and Barrett's Esophagus in Japanese Patients.
Background Kyphosis is a risk factor for the presence of hiatal hernia, which is a strong predictor of Barrett's esophagus. However, the association between kyphosis and Barrett's esophagus has not ye...
Adenocarcinoma in Barrett's Esophagus.
To the Editor: In their population-based cohort study, Hvid-Jensen et al. (Oct. 13 issue)(1) report an annual risk of esophageal adenocarcinoma of 0.12% among patients with Barrett's esophagus. This a...
