Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barrett's Esophagus
Conditions
Barrett's Esophagus - Esophageal Neoplasms
Conditions: official terms
Barrett Esophagus - Esophageal Neoplasms
Conditions: Keywords
Barrett's Esophagus, Esophageal neoplasms, Radiofrequency ablation, Endoscopic mucosal resection
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Radiofrequency Ablation(RFA) by HALO device. Type: Device
Name: Endoscopic mucosal resection(EMR) by mucosectomy kit. Type: Device
Overall Status
Recruiting
Summary
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).
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
University Of Chicago
Chicago, Illinois, United States
Status: Recruiting
Contact: Ann Koons - 773-702-1456 - akoons@medicine.bsd.uchicago.edu
Barnes-Jewish Hospital
St.Louis, Missouri, United States
Status: Recruiting
Contact: Thomas Hollander, MD - 314-747-1973 - tholland@dom.wustl.edu
Columbia University
New York, New York, United States
Status: Recruiting
Contact: Adriana Rodriguez - 212-304-5606 - ar2059@columbia.edu
Start Date
September 2011
Completion Date
June 2018
Sponsors
Midwest Biomedical Research Foundation
Source
Midwest Biomedical Research Foundation
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page