Surveillance vs. Endoscopic Therapy for Barrett's Esophagus With Low-grade Dysplasia

Conditions

• Barrett Esophagus
• Barretts Esophagus With Dysplasia
• Esophageal Adenocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 89 Years

Healthy Volunteers

Not accepted

Interventions

• Endoscopic Eradication Therapy — PROCEDURE
  Endoscopic eradication therapy is a procedure performed to destroy the precancerous cells at the bottom of your esophagus, so that healthy cells can grow in their place. It involves procedures to either remove precancerous tissue or burn it. These procedures are performed through the endoscope.

Study Details

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 either remove precancerous tissue or burn it. These procedures can have side effects, so it is not certain whether risking those side effects is worth the benefit people get from the treatments. While both of these procedures are widely accepted approaches to managing the condition, there is not enough research to show if one is better than the other. Barrett's esophagus and low-grade dysplasia does not always worsen to high-grade dysplasia and/or cancer. In fact, it usually does not. So, if a patient's dysplasia is not worsening, doctors would rather not put patients at risk unnecessarily. On the other hand, endoscopic eradication therapy could possibly prevent the worsening of low-grade dysplasia into high-grade dysplasia or cancer (esophageal adenocarcinoma) in some patients. Researchers believe that the results of this study will help doctors choose the safest and most effective procedure for their patients with Barrett's esophagus and low-grade dysplasia. This is a multicenter study involving several academic, community and private hospitals around the United States. Up to 530 participants will be randomized. This study will also include a prospective observational cohort study of up to 150 Barrett's esophagus and low grade dysplasia patients who decline randomization in the randomized control trial but undergo endoscopic surveillance (Cohort 1) or endoscopic eradication therapy (Cohort 2), and are willing to provide longitudinal observational data.

Key Dates

Start date

Jan 24, 2023

Status verified

Nov 2025

Primary completion

Apr 30, 2029

Completion

Apr 30, 2029

Study Design

Enrollment

680 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: Endoscopic Surveillance
  Subjects in the randomized control trial and observational cohort study, undergoing surveillance endoscopy will undergo surveillance biopsies in a 4-quadrant fashion every 1 cm throughout the extent of the Barrett's esophagus using the Seattle biopsy protocol, along with targeted biopsies from any visible lesions. For incident low grade dysplasia (newly diagnosed low grade dysplasia - within 12 months of enrollment), surveillance endoscopies will be performed every 6 months for the first year and then annually until the end of the study period. For prevalent low grade dysplasia (diagnosed \>1 year prior to enrollment), surveillance endoscopies will be performed annually until the end of the study period. The number of evaluations will depend on a subject's enrollment time.
• Experimental: Endoscopic Eradication Therapy
  Subjects undergoing endoscopic eradication therapy will undergo radiofrequency ablation every 2-3 months until complete eradication of intestinal metaplasia (CE-IM) is achieved or 5 treatments have been delivered, whichever is first. After achieving CE-IM, surveillance endoscopy will performed every 6 months for the first year and annually thereafter until the end of the study period. Surveillance biopsies will be obtained using a standardized protocol.

Primary Outcome Measure

Neoplastic Progression [ Time Frame: Baseline, through study completion ]

Central Contacts

• Jillian Welker
  2489127809
  [email protected]
• Sandra Boimbo
  303-724-8892
  [email protected]

Locations (23)

Find similar trials in Los Angeles, CA

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