Nitrous Oxide For Endoscopic Ablation of Refractory Barrett's Esophagus (NO FEAR-BE) (NO FEAR-BE)
Barrett Esophagus, Intestinal Metaplasia, Esophageal Dysplasia
About this trial
This is an interventional treatment trial for Barrett Esophagus
Eligibility Criteria
Inclusion Criteria:
- History of BE with LGD or HGD confirmed with biopsy, or resected intramucosal cancer (IMC) with low risk of recurrence defined as EMR/ESD pathology results negative for: positive margin, >T1a stage, poorly differentiated carcinoma, and lymphovascular invasion.
Prior treatment with RFA who meet either of the following criteria at the enrolling EGD:
2.1. History of at least 3 RFA treatments, with one or more of the following:
- 2.1.1. Residual BE Prague >=C1
- 2.1.2. Residual BE >=M1
- 2.1.3. One or more islands of residual BE >1 cm in diameter
- 2.1.4. Any residual dysplasia in tubular esophagus 2.2. History of at least 2 RFA treatments and < 50% eradication of BE, as judged by estimation of the treating physician.
- 18 or older years of age at time of consent.
- Provides written informed consent.
- Willing to undergo an alternative approved standard of care treatment for their condition.
- Willing and able to comply with study requirements for follow-up.
- No prior history of balloon or spray cryotherapy esophageal treatment. Prior APC is allowable.
Exclusion Criteria:
- Residual BE Prague length measuring >C3 or >M8 after RFA treatment.
- Dysplasia or IM confined only to the gastric cardia (BE Prague C0M0).
- Pre-existing esophageal stenosis/stricture preventing advancement of a therapeutic endoscope during screening/baseline EGD. Subjects are eligible if the stenosis/stricture is dilated to at least 15mm, but baseline treatment may need to be delayed per protocol.
- Symptomatic, untreated esophageal strictures.
Any endoscopically-visualized abnormalities such as ulcers, masses or nodules during screening/baseline EGD. Subjects with nodular dysplasia or IMC identified during screening/baseline EGD may be treated with EMR or ESD and return for baseline treatment in this study at least 6 weeks later given that:
5.1. Follow-up endoscopy must be negative for nodular dysplasia (visually clear of nodular dysplasia).
5.2. Patients with IMC must be at low risk for recurrence, confirmed by EMR/ESD pathology results negative for: positive margin, >T1a stage, poorly differentiated carcinoma, and lymphovascular invasion.
- EMR or ESD < 6 weeks prior to baseline treatment.
- Untreated invasive esophageal malignancy, including margin-positive EMR/ESD.
- Active reflux esophagitis grade B or higher assessed during screening/baseline EGD.
- Severe medical comorbidities precluding endoscopy or limiting life expectancy to less than 2 years in the judgment of the endoscopist.
- Uncontrolled coagulopathy.
- Inability to hold use of anti-coagulation medications or non-aspirin anti-platelet agents (APAs) for the duration recommended per ASGE guidelines for a high-risk endoscopy procedure.
- Active fungal esophagitis.
- Known portal hypertension, visible esophageal varices, or history of esophageal varices.
- General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation.
- Pregnant or planning to become pregnant during period of study participation.
- Patient refuses or is unable to provide written informed consent.
- Prior esophageal surgery with the exception of uncomplicated nissen fundoplication.
Sites / Locations
- University of Alabama at BirminghamRecruiting
- Georgetown UniversityRecruiting
- Johns Hopkins UniversityRecruiting
- Mayo Clinic RochesterRecruiting
- Northwell HealthRecruiting
- Icahn School of Medicine at Mount Sinai
- Columbia UniversityRecruiting
- UNC Chapel HillRecruiting
- University Hospitals Cleveland Medical CenterRecruiting
- Geisinger ClinicRecruiting
- Medical University of South CarolinaRecruiting
- UTHealth Science Center/Herman MemorialRecruiting
Arms of the Study
Arm 1
Experimental
Cryoballoon Focal Ablation System (CbFAS) Treatment
Subjects undergoing CbFAS treatment as part of their clinical care for their condition.