Clinical trial NCT01572987: Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barrett's Esophagus
Official title: Endoscopic Resection or Ablation for Patients With Dysplasia or Intramucosal Cancer in Barrett's Esophagus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Barrett's Esophagus
Esophageal Neoplasms
Keywords: Barrett's Esophagus
Esophageal neoplasms
Radiofrequency ablation
Endoscopic mucosal resection
Lead sponsor: Midwest Veterans' Biomedical Research Foundation
Sponsor class: OTHER
Collaborators: name: American Society for Gastrointestinal Endoscopy
name: Cook Group Incorporated
name: Washington University School of Medicine
name: Columbia University
name: University of Chicago
First posted: 2012-04-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Complete histological eradication of Barrett's esophagus
timeFrame: 12 months
Secondary outcomes:
measure: Complete histological clearance of dysplasia
timeFrame: 12 months
measure: Complication rates
timeFrame: 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University Of Chicago
state: Illinois
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Kansas City VA Medical Center
name: Prateek Sharma, MD
role: PRINCIPAL_INVESTIGATOR
References:
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