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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Midwest Biomedical Research Foundation
Sponsor:
Collaborators:
American Society for Gastrointestinal Endoscopy
Cook
Washington University School of Medicine
Columbia University
University of Chicago
Information provided by (Responsible Party):
PRATEEK SHARMA, Kansas City Veteran Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01572987
First received: April 4, 2012
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention Phase
Barrett's Esophagus
Esophageal Neoplasms
Device: Radiofrequency Ablation(RFA) by HALO device.
Device: Endoscopic mucosal resection(EMR) by mucosectomy kit.
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Resection or Ablation for Patients With Dysplasia or Intramucosal Cancer in Barrett's Esophagus

Resource links provided by NLM:


Further study details as provided by Midwest Biomedical Research Foundation:

Primary Outcome Measures:
  • Complete histological eradication of Barrett's esophagus [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete histological clearance of dysplasia [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Complication rates [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 82
Study Start Date: September 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Duette multi-band mucosectomy kit (Cook Medical).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572987

Contacts
Contact: April Higbee, RN,BSN 816-861-4700 ext 57456 april.higbee@va.gov

Locations
United States, Illinois
University Of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Ann Koons    773-702-1456    akoons@medicine.bsd.uchicago.edu   
Principal Investigator: Iriving Waxman, MD         
United States, Missouri
Barnes-Jewish Hospital Recruiting
St.Louis, Missouri, United States, 63141
Contact: Thomas Hollander, MD    314-747-1973    tholland@dom.wustl.edu   
Principal Investigator: Steven Edmundowicz, MD         
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Adriana Rodriguez    212-304-5606    ar2059@columbia.edu   
Principal Investigator: Julian Abrams, M.D.         
Sponsors and Collaborators
Midwest Biomedical Research Foundation
American Society for Gastrointestinal Endoscopy
Cook
Washington University School of Medicine
Columbia University
University of Chicago
Investigators
Principal Investigator: Prateek Sharma, MD Kansas City VA Medical Center
  More Information

Publications:

Responsible Party: PRATEEK SHARMA, Principal Investigator, Kansas City Veteran Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01572987     History of Changes
Other Study ID Numbers: PS0058
Study First Received: April 4, 2012
Last Updated: January 21, 2014
Health Authority: United States: Federal Government

Keywords provided by Midwest Biomedical Research Foundation:
Barrett's Esophagus
Esophageal neoplasms
Radiofrequency ablation
Endoscopic mucosal resection

Additional relevant MeSH terms:
Barrett Esophagus
Neoplasms
Esophageal Neoplasms
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on July 20, 2014