APE-Study: Ablation of Barrett's Mucosa vs. Surveillance... | NCT00546065

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Intermediate results have shown a significant difference in the outcome of ablation and non-ablation patients. Therefore, the study was stopped.

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Oct 16, 2007

First Submission Date that Met QC Criteria

Oct 17, 2007

First Posted Date

Oct 18, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2011

Last Update Posted Date

Nov 29, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

68Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ablation of Barretts with concomitant esomeprazole therapy	Other	comparison of recurrence-free survival	Drug: esomeprazole treatment
non ablation	No Intervention	non ablation only surveillance	Drug: esomeprazole treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
esomeprazole treatment	Drug	concomitant esomeprazole treatment	ablation of Barretts with concomitant esomeprazole therapy non ablation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
recurrence-free survival	recurrence-free survival during 3 years of follow-up	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D011230	Precancerous Conditions
D009369	Neoplasms
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases