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

Barrett's Esophagus Clinical Trial

— APE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00546065
• Other study ID #: D9612L00088
• Status: Terminated
• Phase: N/A
• First received: October 16, 2007
• Last updated: November 25, 2011
• Start date: August 2006
• Est. completion date: September 2010

Study information

• Verified date: November 2011
• Source: HSK Wiesbaden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 68
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus

Intervention

Drug:
• esomeprazole treatment
concomitant esomeprazole treatment

Locations

Country	Name	City	State
Germany	HSK Wiesbaden	Wiesbaden	Hesse

Sponsors (1)

Lead Sponsor	Collaborator
HSK Wiesbaden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence-free survival	recurrence-free survival during 3 years of follow-up	3 years	No