Endoscopic Resection or Ablation for Patients With Dysplasia or Intramucosal Cancer in Barrett's Esophagus
18 Years
N/A
Both
Barrett's Esophagus, Esophageal Neoplasms
Trial Information
Endoscopic Resection or Ablation for Patients With Dysplasia or Intramucosal Cancer in Barrett's Esophagus
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete histological eradication of Barrett's esophagus
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Prateek Sharma, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Kansas City VA Medical Center
Authority:
United States: Federal Government
Study ID:
PS0058
NCT ID:
NCT01572987
Start Date:
September 2011
Completion Date:
May 2013
Related Keywords:
- Barrett's Esophagus
- Esophageal Neoplasms
- Barrett's Esophagus
- Esophageal neoplasms
- Radiofrequency ablation
- Endoscopic mucosal resection
- Barrett Esophagus
- Neoplasms
- Esophageal Diseases
- Esophageal Neoplasms
Name | Location |
|---|---|
| Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
| Columbia University | New York, New York 10032-3784 |
| University of Chicago | Chicago, Illinois 60637 |
