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

Stopped early · Not applicable

Conditions studied: Barrett's Esophagus, Esophageal Neoplasms

In brief

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).

Key facts

Study ID

NCT01572987

Run by

Midwest Biomedical Research

People needed

12

Starts

2011-09-01

Expected to finish

2017-05-01

Last updated by the study team

2017-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University Of Chicago — Chicago, Illinois, United States
• Barnes-Jewish Hospital — St Louis, Missouri, United States
• Columbia University — New York, New York, United States

Full record on ClinicalTrials.gov

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