Comparing two methods for sampling Barrett's esophagus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of the standard Seattle biopsy protocol against the wide-area transepithelial sampling (WATS3D) method in patients with Barrett's esophagus. Participants will undergo upper endoscopy with high-definition imaging, followed by randomization to receive one of the two sampling techniques. Both methods will be evaluated for their ability to detect dysplasia and potential early signs of esophageal adenocarcinoma. The study seeks to determine which sampling approach provides better diagnostic accuracy and patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Surveillance Population

* Undergoing surveillance endoscopy for a diagnosis of non-dysplastic Barrett's esophagus (NDBE, based on last endoscopic procedure; patients with prior history of low-grade dysplasia/indefinite for dysplasia with NDBE at last endoscopy can be included)
* Barrett's esophagus (BE) length of at least M1
* English and Spanish speaking
* Able to comprehend and complete the consent form
* Age18-89 years
* Life-expectancy of at least 2 years

Screening Population

* Undergoing endoscopy for screening of BE
* BE length of at least M1
* English and Spanish speaking
* Able to comprehend and complete the consent form
* Age 18-89 years
* Expected life-expectancy of at least 2 years

Physicians

-All participating sites will include physicians who are trained in the use of WATS3D and certified by the site PI. All endoscopists will need to complete a minimum of three cases to be eligible to participate in the study.

Exclusion Criteria:

Surveillance Population

* BE patients undergoing surveillance or evaluation for endoscopic eradication therapy (EET) for prior diagnosis of BE related dysplasia or esophageal adenocarcinoma (EAC)
* Active erosive esophagitis with LA Grade B or higher
* Esophageal varices
* Prior history of EET
* Prior history of esophageal or gastric surgery, except for uncomplicated fundoplication
* Pregnancy

Screening Population

* BE patients undergoing surveillance or evaluation for EET for prior diagnosis for BE-related dysplasia or EAC
* Active erosive esophagitis with LA Grade B or higher
* Esophageal varices
* Prior history of esophageal or gastric surgery, except for uncomplicated fundoplication
* Pregnancy

Where it's running

• Arizona Centers of Digestive Health
  Gilbert, Arizona, United States Recruiting
• UCLA / Jonsson Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• Kaiser Permanente
  Oakland, California, United States Recruiting
• University of Colorado Anschutz Medical Campus
  Aurora, Colorado, United States Recruiting
• Connecticut Clinical Research Institute
  Bristol, Connecticut, United States Recruiting
• Suncoast Endoscopy of Sarasota
  Sarasota, Florida, United States Recruiting

Study contacts

• Principal investigator: Sachin Wani, MD — University of Colorado, Denver
• Study coordinator: Alexa R DeBord, MS
• Email: alexa.debord@cuanschutz.edu
• Phone: 303-724-0432

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using a swallowable sponge to collect esophageal samples for Barrett's esophagus detection

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• Registry for patients undergoing esophageal cancer screening

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• Comparing surveillance and therapy for Barrett's esophagus with low-grade dysplasia

  This study is testing whether regular check-ups or a treatment to remove precancerous cells is better for people with Barrett's esophagus and low-grade dysplasia.

  Recruiting at 28 sites University of Colorado, Denver · Birmingham, Alabama and 29 other locations · NCT05753748

• Itraconazole with endoscopic ablation to prevent esophageal cancer in high‑risk Barrett's esophagus

  This study tests if adding itraconazole to the standard endoscopic ablation can better prevent esophageal cancer in people with high-risk Barrett's esophagus.

  Recruiting at 4 sites Phase 2 National Cancer Institute (NCI) · Kansas City, Kansas and 5 other locations · NCT06732388

• Detecting Barrett's Esophagus in Patients Without GERD Symptoms

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  Recruiting at 5 sites Case Comprehensive Cancer Center · Aurora, Colorado and 4 other locations · NCT06687603

• Assessing Barrett's Esophagus in Patients with Anorexia Nervosa and Purging Behaviors

  This study is trying to see if people with anorexia nervosa who purge have Barrett's esophagus, using non-invasive tests to check for this condition in patients aged 18-65.

  Recruiting at 3 sites Denver Health and Hospital Authority · Denver, Colorado and 2 other locations · NCT06532734

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.