Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barrett's Esophagus (ERADICATE)

May 24, 2017 updated by: PRATEEK SHARMA, Midwest Biomedical Research Foundation

Endoscopic Resection or Ablation for Patients With Dysplasia or Intramucosal Cancer in Barrett's Esophagus

This clinical trial will evaluate a patient population with Barrett's esophagus(BE) containing high grade dysplasia or intramucosal cancer and compare the effects of endoscopically-guided radiofrequency ablation system(RFA) and endoscopically-guided stepwise endoscopic mucosal resection(S-EMR).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a multi-center prospective, randomized controlled trial conducted at 4 centers. The patients with high grade dysplasia(HGD) and/or esophageal cancer(EC) who meet the study criteria will be enrolled, undergo a baseline diagnostic EMR and then be randomized in a 1:1 ratio to undergo treatment by either S-EMR or radiofrequency ablation(RFA). The initial staging EMR will not extend more than 50% of the esophageal circumference or more than 2 cm in longitudinal extent. Patients in the S-EMR group will undergo step-wise eradication of the BE segment using the Duette multi-band mucosectomy kit (Cook Medical, FDA approved) whereas those in the RFA group will undergo BE ablation using the endoscopically-guided HALO radiofrequency ablation system (Barrx Medical, FDA approved).

Both treatment groups will undergo their respective treatment sessions every 2 months until either no Barrett's esophagus is seen or until a maximum of 4 treatment sessions. Once there is no visible Barrett's esophagus, patients will undergo surveillance biopsies (random 4 quadrant biopsies every 1 cm of the neo-squamous mucosa and random biopsies of the cardia) to evaluate for complete eradication of Barrett's esophagus. Regardless of whether there is visible Barrett's esophagus, all patients will undergo repeat endoscopy every 2 months for 1 year after enrollment. If no visible Barrett's esophagus is seen during the endoscopy, then surveillance biopsies to evaluate for dysplasia will be taken. Regardless of whether this is any visible Barrett's esophagus, all patients will undergo surveillance biopsies at 12 months after enrollment.

The objective of this study is to compare the proportion of patients with complete eradication of Barrett's esophagus using S-EMR versus RFA at 12 months.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Barnes-Jewish Hospital
    • New York
      • New York, New York, United States, 10032
        • Columbia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects shall be screened according to the following inclusion criteria. An answer of "no" to any inclusion criterion disqualifies a subject from participating in this study.

  • Patients age: > 18 years
  • Subject has documented diagnosis of Barrett's esophagus, maximum endoscopic length of no more than C2M5 (i.e. no more than 2cm of circumferential extent and no more than 5cm of tongues) containing HGD/EC as follows:
  • HGD or EC documented on biopsy within previous 6 months from enrollment
  • Histology slides reviewed at central pathology service for ERADICATE Trial confirm HGD/EC.
  • Endoscopically visible lesion/area/pattern in a patient with HGD/EC either by high definition white light endoscopy, narrow band imaging, confocal laser endomicroscopy, or another enhanced imaging tool.
  • Ability to take oral proton pump inhibitor
  • For female subjects of childbearing potential, a negative urine pregnancy test within 2 weeks of enrollment and any subsequent endoscopy encounter
  • Subject is eligible for treatment and follow-up endoscopy and biopsy as required by the investigational plan
  • Ability to discontinue aspirin/NSAIDs/Clopidogrel 7 days before and after all ablation procedures
  • Ability of provide written, informed consent and understands the responsibilities of trial participation NOTE: At the Kansas City Veterans Hospital, participants must be eligible for care at the VA in order to be enrolled. Other sites listed are able to enroll non-veterans.

Exclusion Criteria:

Subjects shall be screened according to the following exclusion criteria. An answer of "yes" to any exclusion criterion disqualifies a subject from participating in this study.

  • Extent of BE >C2M5
  • The subject is pregnant or planning a pregnancy during the study period (12 months after treatment)
  • Esophageal stricture preventing passage of endoscope or catheter
  • Active erosive esophagitis
  • History of malignancy of the esophagus, esophageal varices or coagulopathy
  • Prior radiation therapy to the esophagus, except head and neck region radiation therapy.
  • Any previous ablation therapy within the esophagus (photodynamic therapy, multipolar electrocoagulation, argon plasma coagulation, laser treatment, or other)
  • Any previous EMR in the esophagus
  • Any previous esophageal surgery, including fundoplication
  • Evidence of esophageal varices during treatment endoscopy
  • Subject has a life-expectancy of less than two years due to an underlying medical condition
  • Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines
  • Subject has an implantable pacing device (examples: Implantable cardiac defibrillator, neurostimulator, cardiac pacemaker) and has not received clearance for enrollment in this study by specialist responsible for the pacing device
  • The subject is currently enrolled in an investigational drug or device trial that clinically interferes with the ERADICATE trial.
  • Subject suffers from psychiatric or other illness deemed by the investigator as an inability to comply with protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: RFA arm
Under this arm, study patients will undergo radiofrequency ablation.
Device: Radiofrequency Ablation(RFA) by HALO device.
RFA or Surveillance every 2 months for 1 year.
Other Names:
  • HALO Ablation Technology(BÂRRX Medical, Inc).
Active Comparator: EMR arm
Under this arm, the individuals will undergo endoscopic mucosal resection.
Device: Endoscopic mucosal resection(EMR) by mucosectomy kit.
EMR or surveillance every 2 months.
Other Names:
  • Duette multi-band mucosectomy kit (Cook Medical).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete histological eradication of Barrett's esophagus
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Complete histological clearance of dysplasia
Time Frame: 12 months
12 months
Complication rates
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Midwest Biomedical Research Foundation

Collaborators

Washington University School of Medicine
University of Chicago
Columbia University
Cook Group Incorporated
American Society for Gastrointestinal Endoscopy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

April 4, 2012

First Submitted That Met QC Criteria

April 4, 2012

First Posted (Estimate)

April 6, 2012

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 24, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PS0058

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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