Barrett's Esophagus With DysplasiaNCT07756710
Ursodeoxycholic Acid in Barrett's Endotherapy
An observational study of Barrett's Esophagus With Dysplasia, run by Columbia University at 1 site in United States.
Trial summary
Barrett's esophagus (BE) is a condition in which the normal lining of the esophagus is replaced by abnormal tissue that can increase the risk of esophageal cancer. Endoscopic eradication therapy (EET) removes this abnormal tissue, but most patients need several treatment sessions, leading to higher costs… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett's Esophagus With Dysplasia
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Barrett's esophagus (BE) and low-grade dysplasia (LGD), high-grade dysplasia (HGD), or intramucosal adenocarcinoma undergoing endoscopic eradication therapy who are taking ursodeoxycholic acid (UDCA).
Who may be able to join
- Barrett's esophagus, defined as endoscopic evidence of BE with esophageal biopsies showing intestinal metaplasia.
- Pre-treatment histology of low- or high-grade dysplasia or intramucosal adenocarcinoma.
- BE length ≥2 cm (Prague classification: any C, M≥2). The decision was made to exclude patients with BE segments shorter than 2 cm, as assessment of % neosquamous regrowth in shorter segments is likely neither reliable nor highly reproducible.
- Prior endoscopic resection of focal lesions is permitted. Endoscopic resection of nodular lesions must be performed prior to initiating ablation therapy.
- Taking UDCA 13-15 mg/kg divided into twice daily dosing.
- Either one of the following:
- No prior endoscopic ablation therapy, OR
- Single prior ablation treatment and <50% response (i.e. <50% neosquamous replacement of original BE segment) and ≥2 cm of residual BE
Who cannot join
- Allergy, hypersensitivity, or intolerance to UDCA.
- Age ≤18 years.
- Pregnant or planning to get pregnant during the study period.
- Unable to give informed consent.
- Known acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula (contraindications to UDCA use).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
Katharine Godfrey, 6463170740, kb3217@cumc.columbia.edu
Julian Abrams, MD
About this study
Official title: Cohort Study of Patients With Barrett's Esophagus-Associated Neoplasia Receiving Ursodeoxycholic Acid in the Setting of Endoscopic Ablation
Barrett's esophagus (BE) is a condition in which the normal lining of the esophagus is replaced by abnormal tissue that can increase the risk of esophageal cancer. Endoscopic eradication therapy (EET) removes this abnormal tissue, but most patients need several treatment sessions, leading to higher costs, inconvenience, and cumulative risk. Research suggests that bile reflux, especially a bile acid called deoxycholic acid (DCA), may interfere with healing after treatment by promoting regrowth of Barrett's tissue. Ursodeoxycholic acid (UDCA), an FDA-approved medication used for certain liver and gallbladder conditions, lowers harmful bile acids and may help the normal esophageal lining grow back more effectively. In this pilot study, patients undergoing endoscopic treatment and taking UDCA will be followed to see whether UDCA treatment improves healing and reduces the number of procedures needed. If successful, this approach could lower costs, decrease risks, and make treatment more accessible for patients at risk of esophageal cancer.
- Conditions
- Barrett's Esophagus With Dysplasia
- Keywords
- ursodeoxycholic acid, Barrett's Esophagus
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Barrett's esophagus-associated neoplasia | Patients with Barrett's esophagus-associated neoplasia who are being treated with UDCA and are undergoing endoscopic eradication therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Neosquamous Regrowth (PNR) after a single treatment session
At each endoscopy, photos will be taken starting at the GE junction and every 1 cm along the original length of BE. Three independent reviewers (the PI and two collaborators) will score the percent neosquamous regrowth based on the photo images comparing the baseline and follow-up endoscopy, with each reviewer blinded to the other reviewers' scores. PNR estimates will be made in increments of 5% (5%, 10%, 15%, etc.). The mean of the three reviewer's assessments will serve as the final PNR for each subject. We will then calculate the mean PNR with associated 95% CI for the study population.
Measured: Baseline endoscopy to first follow-up endoscopy at approx. 2 months +/- 4 weeks
Secondary outcomes (1)
Effects of UDCA on refluxate bile acid composition
Within-individual change in total deoxycholic acids (DCAs) will be assessed and reported as median and interquartile range. Total DCAs will be calculated as the sum of the unconjugated and conjugated forms of DCA (DCA, glyco-DCA, tauro-DCA).
Measured: Baseline endoscopy until complete eradication of BE or after 4 treatments (approximately 8-10 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett's Esophagus With DysplasiaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy
- Responsible party
- Principal investigator, Julian A Abrams, MD, Columbia University
- Investigators
- Julian Abrams, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756710
- Sponsor's protocol ID
- ACYY0832
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Patients With Barrett's Esophagus-Associated Neoplasia Receiving Ursodeoxycholic Acid in the Setting of Endoscopic Ablation
- ClinicalTrials.gov ID
- NCT07756710
- Acronym / sponsor ID
- ACYY0832
- Conditions
- Barrett's Esophagus With Dysplasia
- Keywords
- ursodeoxycholic acid, Barrett's Esophagus
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Barrett's esophagus (BE) is a condition in which the normal lining of the esophagus is replaced by abnormal tissue that can increase the risk of esophageal cancer. Endoscopic eradication therapy (EET) removes this abnormal tissue, but most patients need several treatment sessions, leading to higher costs, inconvenience, and cumulative risk. Research suggests that bile reflux, especially a bile acid called deoxycholic acid (DCA), may interfere with healing after treatment by promoting regrowth of Barrett's tissue. Ursodeoxycholic acid (UDCA), an FDA-approved medication used for certain liver and gallbladder conditions, lowers harmful bile acids and may help the normal esophageal lining grow back more effectively. In this pilot study, patients undergoing endoscopic treatment and taking UDCA will be followed to see whether UDCA treatment improves healing and reduces the number of procedures needed. If successful, this approach could lower costs, decrease risks, and make treatment more accessible for patients at risk of esophageal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Barrett's esophagus-associated neoplasia | – | –Patients with Barrett's esophagus-associated neoplasia who are being treated with UDCA and are undergoing endoscopic eradication therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Barrett's esophagus (BE) and low-grade dysplasia (LGD), high-grade dysplasia (HGD), or intramucosal adenocarcinoma undergoing endoscopic eradication therapy who are taking ursodeoxycholic acid (UDCA).
Key inclusion criteria (8 listed)
- Barrett's esophagus, defined as endoscopic evidence of BE with esophageal biopsies showing intestinal metaplasia.
- Pre-treatment histology of low- or high-grade dysplasia or intramucosal adenocarcinoma.
- BE length ≥2 cm (Prague classification: any C, M≥2). The decision was made to exclude patients with BE segments shorter than 2 cm, as assessment of % neosquamous regrowth in shorter segments is likely neither reliable nor highly reproducible.
- Prior endoscopic resection of focal lesions is permitted. Endoscopic resection of nodular lesions must be performed prior to initiating ablation therapy.
- Taking UDCA 13-15 mg/kg divided into twice daily dosing.
Key exclusion criteria (5 listed)
- Allergy, hypersensitivity, or intolerance to UDCA.
- Age ≤18 years.
- Pregnant or planning to get pregnant during the study period.
- Unable to give informed consent.
- Known acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula (contraindications to UDCA use).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent Neosquamous Regrowth (PNR) after a single treatment session
Time frame: Baseline endoscopy to first follow-up endoscopy at approx. 2 months +/- 4 weeks
At each endoscopy, photos will be taken starting at the GE junction and every 1 cm along the original length of BE. Three independent reviewers (the PI and two collaborators) will score the percent neosquamous regrowth based on the photo images comparing the baseline and follow-up endoscopy, with each reviewer blinded to the other reviewers' scores. PNR estimates will be made in increments of 5% (5%, 10%, 15%, etc.). The mean of the three reviewer's assessments will serve as the final PNR for each subject. We will then calculate the mean PNR with associated 95% CI for the study population.
1 secondary outcome
Effects of UDCA on refluxate bile acid composition
Time frame: Baseline endoscopy until complete eradication of BE or after 4 treatments (approximately 8-10 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julian Abrams, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett's Esophagus With Dysplasia, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katharine Godfrey (6463170740, kb3217@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Neosquamous Regrowth (PNR) after a single treatment session (time frame: Baseline endoscopy to first follow-up endoscopy at approx. 2 months +/- 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.