NCT00546065

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

November 29, 2011

Status Verified

November 1, 2011

Enrollment Period

4.1 years

First QC Date

October 16, 2007

Last Update Submit

November 25, 2011

Conditions

Barrett's Esophagus

Keywords

Barrett's esophagusablationesomeprazoleBarrett's cancerAblation of Barrett's esophagusSurveillance of Barrett's esophagus after endoscopic resection of Barrett's cancerRecurrence of Barrett's cancer

Outcome Measures

Primary Outcomes (1)

  • recurrence-free survival

    recurrence-free survival during 3 years of follow-up

    3 years

Study Arms (2)

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

esomeprazole treatmentDRUG

concomitant esomeprazole treatment

ablation of Barretts with concomitant esomeprazole therapynon ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Attempted ablation therapy before the trial
  • Treatment duration of early Barrett's cancer \> 12 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HSK Wiesbaden

Wiesbaden, Hesse, 65199, Germany

Location

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Christian Ell, MD PhD

    HSK Wiesbaden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2007

First Posted

October 18, 2007

Study Start

August 1, 2006

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

November 29, 2011

Record last verified: 2011-11

Locations

DE(1)