Clinical trial NCT00546065: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Barrett's Esophagus
Keywords: 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
Lead sponsor: HSK Wiesbaden
Sponsor class: OTHER
First posted: 2007-10-18
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: recurrence-free survival
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wiesbaden
country: Germany
facility: HSK Wiesbaden
state: Hesse
Study officials:
affiliation: HSK Wiesbaden
name: Christian Ell, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: