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โ† Trials
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Surveillance vs. Endoscopic Therapy for Barrett's Esophagus With Low-grade Dysplasia

RecruitingNAAges 18 Years - 89 YearsAllUniversity of Colorado, Denver
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to learn the best approach to treating patients with known or suspected Barrett's esophagus by comparing endoscopic surveillance to endoscopic eradication therapy. To diagnose and manage Barrett's esophagus and low-grade dysplasia, doctors commonly use procedures called endoscopic surveillance and endoscopic eradication therapy. Endoscopic surveillance is a type of procedure where a physician will run a tube with a light and a camera on the end of it down the patients throat and remove a small piece of tissue. The piece of tissue, called a biopsy, is about the size of the tip of a ball-point pen and is checked for abnormal cells and cancer cells. Endoscopic eradication therapy is a kind of surgery which is performed to destroy the precancerous cells at the bottom of the esophagus, so that healthy cells can grow in their place. It involves procedures to eith

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Any patient with Barrett's esophagus and low grade dysplasia who provides informed consent AND: Meets all the following criteria will be eligible for enrollment: 1. Male or female, age โ‰ฅ18 years; 2. Subject has endoscopic evidence of Barrett's esophagus characterized by the presence of salmon-colored mucosa in the tubular esophagus of at least 1 cm in length as well as endoscopic biopsies from the involved areas demonstrating columnar metaplasia with goblet cells. This inclusion criterion will exclude patients with intestinal metaplasia with dysplasia of the gastric cardia; 3. Biopsies within the previous 12 months demonstrating Barrett's esophagus and indeterminate for dysplasia or low grade dysplasia; 4. Confirmation of low grade dysplasia by expert central pathology panel from biopsies obtained within the previous 12 months; 5. Demonstrated ability to tolerate proton pump inhibitor (PPI) or potassium-competitive acid blocker (PCAB) therapy based on patient self-report; and, 6. Ability to discontinue antiplatelet and anticoagulant therapy based on standard guideline recommendations prior to and after endoscopic procedures. Exclusion Criteria: 1. Pregnancy; 2. Prior endoscopic eradication therapy for Barrett's esophagus; 3. History of high grade dysplasia or esophageal adenocarcinoma; 4. History of esophageal resection/esophagectomy 5. Active erosive esophagitis (Los Angeles Grade B or higher) - patients are eligible upon resolution of erosive esophagitis; 6. Esophageal strictures precluding passage of the endoscope or treatment catheters - patients are eligible upon resolution of esophageal stricture due to endoscopic dilation or resolution with medical therapy; 7. Esophageal varices or known portal hypertension; and 8. Life expectancy of \<2 years as judged by the site investigator. \* Patients are eligible for enrollment and randomization if they meet the above eligibility criteria. It should be noted that the presence of a visible lesion (nodularity) at the index endoscopy is not an exclusion criterion. Those with visible lesions will undergo endoscopic mucosal resection (EMR) to determine pathology. If HGD or EAC pathology is determined, then the subject will exit from the study after a 30-day safety follow up
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What it tests

  • Endoscopic Eradication Therapy
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Where

30 sites
University of Alabama at Birmingham
Birmingham, United States
Mayo Clinic
Scottsdale, United States
University of California, Los Angeles
Los Angeles, United States
Kaiser Permanente Oakland Medical Center
Oakland, United States
Kaiser Permanente
San Jose, United States
University of Colorado
Aurora, United States
Mayo Clinic
Jacksonville, United States
Florida Digestive Health Specialists
Sarasota, United States

โ€ฆand 22 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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