Know Cancer

or
forgot password

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


N/A
18 Years
N/A
Not Enrolling
Both
Barrett's Esophagus

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

recurrence-free survival

Outcome Description:

recurrence-free survival during 3 years of follow-up

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Christian Ell, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

HSK Wiesbaden

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

D9612L00088

NCT ID:

NCT00546065

Start Date:

August 2006

Completion Date:

September 2010

Related Keywords:

  • Barrett's Esophagus
  • 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
  • Barrett Esophagus

Name

Location