Nitrous Oxide For Endoscopic Ablation of Refractory Barrett's Esophagus (NO FEAR-BE)

Ki vehet részt

• 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

Ki nem vehet részt

• 5. Any endoscopically visualized abnormalities such as ulcers, masses, or nodules found in the BE 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
• Prior esophageal surgery with the exception of uncomplicated nissen fundoplication
• Untreated invasive esophageal malignancy, including margin-positive EMR/ESD
• Known portal hypertension, visible esophageal varices, or history of esophageal varices
• 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
• Residual BE Prague length measuring >C3 or >M8 after RFA treatment
• Dysplasia or IM confined only to the gastric cardia
• 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
• Active reflux esophagitis grade B or higher in the BE 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
• Active fungal esophagitis
• 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