# A Multicenter Randomized Controlled Trial of Surveillance versus. Endoscopic Therapy for Barretts Esophagus with Low-grade Dysplasia: The SURVENT Trial

> **NIH NIH U34** · UNIVERSITY OF COLORADO DENVER · 2020 · $384,138

## Abstract

Project Summary/Abstract
Barrett's esophagus (BE), a metaplastic change of the esophageal lining associated with chronic
gastroesophageal reflux disease, is the only known precursor to esophageal adenocarcinoma (EAC). EAC is
one of the most rapidly increasing cancers in the United States, frequently presenting at an advanced stage
and associated with a dismal 5-year survival rate. Endoscopic eradication therapy (EET) is the standard of
care for patients with BE and high-grade dysplasia (HGD) or mucosal EAC. However, a central unresolved
issue is whether BE patients with low-grade dysplasia (LGD) benefit from EET. The diagnosis of LGD is far
more common than HGD and is associated with a lower risk of EAC, so it is unclear whether the costs and
complications of EET are justified in this group of patients. The presence of clinical equipoise and the
importance of this question indicates that a trial of endoscopic surveillance versus EET in this patient
population is an urgent, unmet gap in our current knowledge regarding treatment of this common condition.
We aim to address this knowledge gap in a two-step process. Step 1 is a one year U34 planning grant during
which we aim to develop the necessary study infrastructure, research protocols and documents in close
collaboration with the NIDDK. Step 2 is a five year U01 multicenter randomized controlled trial to compare EET
and endoscopic surveillance for the management of LGD. Specific Aim #1 will compare the two approaches
using the primary endpoint of neoplastic progression rate (progression to HGD or mucosal or invasive EAC).
Specific Aim #2 will compare defined patient-centered outcomes such as health-related quality of life between
the two treatment groups. Specific Aim #3 will compare the performance of molecular (TissueCypher and p53
immunohistochemistry) and imaging (wide-area transepithelial sampling – WATS) biomarkers to conventional
histologic assessment of dysplasia via forceps biopsy to improve risk-stratification in BE with LGD patients.
Biological samples will also be obtained at study enrollment and during follow-up from all enrolled subjects to
establish a biorepository for future translational research initiatives.
The relevance of this work to the public health is high. BE is a common condition affecting 2-3% of adult US
population and LGD is seen in up to 40% of BE patients. This is a precursor for EAC, a cancer that has
increased in incidence over the past four decades. Millions of dollars are spent yearly on the management of
patients with BE and EAC. The impact of our innovative study will include identifying the best patient-centered
treatment approach for BE patients with LGD, which will inform the care of thousands of patients annually.

## Key facts

- **NIH application ID:** 9938225
- **Project number:** 1U34DK124174-01
- **Recipient organization:** UNIVERSITY OF COLORADO DENVER
- **Principal Investigator:** VALERIE L DURKALSKI
- **Activity code:** U34 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $384,138
- **Award type:** 1
- **Project period:** 2020-04-17 → 2022-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9938225

## Citation

> US National Institutes of Health, RePORTER application 9938225, A Multicenter Randomized Controlled Trial of Surveillance versus. Endoscopic Therapy for Barretts Esophagus with Low-grade Dysplasia: The SURVENT Trial (1U34DK124174-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/9938225. Licensed CC0.

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