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

Condition(s) targeted: Barrett's Esophagus

Intervention: ablation of Barrett's esophagus using argon plasma coagulation (APC) (Procedure); esomeprazole therapy (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: HSK Wiesbaden

Official(s) and/or principal investigator(s):
Christian Ell, MD PhD, Principal Investigator, Affiliation: HSK Wiesbaden

Overall contact:
Hendrik Manner, MD, Phone: 0049611432420

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.

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 design: Prevention, Randomized, Double-Blind, Parallel Assignment

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Hendrik Manner, MD, Phone: 0049611432420

HSK Wiesbaden, Wiesbaden, Hesse 65199, Germany; Recruiting
Hendrik Manner, MD, Phone: +49611432420

Starting date: August 2006
Ending date: August 2014
Last updated: October 17, 2007