Endoscopic Therapy vs Surveillance for Barrett's Esophagus

(SURVENT Trial)

Recruiting at 24 trial locations

Overseen By Sandra Boimbo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must be taking: Proton pump inhibitors

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Pregnancy, Prior eradication therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 3.5 years

680 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks the best treatment for Barrett's esophagus, a condition where the esophageal lining changes and can sometimes lead to cancer. Researchers are comparing two methods: endoscopic surveillance, which uses regular check-ups with a camera and light to monitor changes, and endoscopic eradication therapy (EET), which removes or destroys abnormal cells. The goal is to determine if one approach is safer and more effective. Candidates for the study include individuals with Barrett's esophagus who have had a biopsy confirming the condition in the past year and can manage medication. As an unphased trial, this study allows patients to contribute to important research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial requires participants to stop taking antiplatelet and anticoagulant medications before and after endoscopic procedures, based on standard guidelines. It does not specify other medications, so you may not need to stop taking them.

What prior data suggests that these endoscopic procedures are safe for managing Barrett's esophagus?

Research has shown that endoscopic eradication therapy is generally safe for treating Barrett's esophagus. While effective, it carries some risks. For instance, about 6.5% of patients may develop esophageal strictures, which narrow the esophagus and can make swallowing difficult. Other side effects, such as bleeding, can occur but are less common.

In many cases, the benefits of removing or destroying precancerous cells outweigh these risks. Doctors consider it a valuable option, especially if the condition could worsen. However, due to possible side effects, discussing the pros and cons with a healthcare provider is important.

Endoscopic surveillance, by contrast, involves regular check-ups to monitor the condition. It is less invasive and has fewer risks but does not actively remove precancerous cells. Choosing between these options depends on individual health needs and preferences. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares two different strategies for managing Barrett's Esophagus: endoscopic eradication therapy and endoscopic surveillance. Endoscopic eradication therapy is unique because it actively aims to eliminate the abnormal tissue using radiofrequency ablation, potentially reducing the risk of progression to cancer. Meanwhile, endoscopic surveillance involves regular monitoring and biopsies to catch any changes early, which is the current standard approach. By comparing these two methods, researchers hope to find out which strategy is more effective at preventing cancer and improving patient outcomes.

What evidence suggests that this trial's treatments could be effective for Barrett's esophagus?

This trial will compare Endoscopic Eradication Therapy (EET) with Endoscopic Surveillance for Barrett's esophagus. Research shows that EET can effectively treat Barrett's esophagus, a condition where the esophagus lining changes and may lead to cancer. Studies have found that this therapy lowers the risk of Barrett's esophagus returning and helps manage precancerous cells. EET involves procedures to remove or destroy abnormal cells, allowing healthy cells to regrow. While side effects can occur, the therapy is generally considered safe and can prevent the condition from worsening. Long-term evidence suggests it can lead to positive results for patients with dysplastic Barrett's esophagus. ^{1 2 6 7 8}

Who Is on the Research Team?

Sachin Wani, MD

Principal Investigator

University of Colorado, Denver

Nicholas J. Shaheen

Principal Investigator

University of North Carolina

Rhonda Souza, MD

Principal Investigator

Baylor University

Valerie Durkalski, MPH, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Barrett's esophagus and low-grade dysplasia, who can tolerate acid-reducing medication and stop blood thinners before endoscopic procedures. It excludes those with high-grade dysplasia or cancer, active severe esophagitis, short life expectancy, pregnancy, prior surgery or treatment on the esophagus, and certain esophageal conditions.

Inclusion Criteria

My tests show I have Barrett's esophagus with specific changes in my esophagus cells.

I have Barrett's esophagus with low grade dysplasia and agree to participate.

My biopsy from the last year shows Barrett's esophagus with low grade dysplasia.

Exclusion Criteria

Life expectancy of <2 years as judged by the site investigator

I have had surgery to remove part or all of my esophagus.

I have had treatment for Barrett's esophagus.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either endoscopic eradication therapy or endoscopic surveillance based on randomization

3.5 years

Every 2-3 months for eradication therapy; every 6 months for surveillance

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Semi-annual follow-up calls

Long-term Follow-up

Continued monitoring of participants for progression to high-grade dysplasia or cancer

Until study completion

What Are the Treatments Tested in This Trial?

Interventions

• Endoscopic Eradication Therapy

Trial Overview The study compares two methods for managing Barrett's esophagus: 'endoscopic surveillance' (monitoring through a camera-tube down the throat) versus 'endoscopic eradication therapy' (surgery to remove or destroy precancerous cells). Up to 530 participants will be randomly assigned to either method in various U.S. hospitals.

How Is the Trial Designed?

Group I: Endoscopic Eradication Therapy Experimental Treatment 1 Intervention

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.

Group II: Endoscopic Surveillance Active Control 1 Intervention

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.

Endoscopic Eradication Therapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Endoscopic Eradication Therapy for:

• Barrett's esophagus with dysplasia
• Early neoplasia

Approved in United States as Endoscopic Eradication Therapy for:

• Barrett's esophagus with dysplasia
• Early esophageal adenocarcinoma

Approved in Canada as Endoscopic Eradication Therapy for:

• Barrett's esophagus with dysplasia
• Early neoplasia

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Baylor University

Collaborator

Trials

65

Recruited

67,600+

University of North Carolina

Collaborator

Trials

174

Recruited

1,457,000+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

Published Research Related to This Trial

Endoscopic eradication therapy (EET) is an effective and safe treatment for managing Barrett's oesophagus related neoplasia, aiming for complete eradication of intestinal metaplasia and subsequent surveillance for recurrence.

EET is now considered the standard of care for high-grade dysplasia and intramucosal carcinoma, while for low-grade dysplasia, both surveillance and ablation are viable options depending on individual patient factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic eradication therapy for Barrett's oesophagus: state of the art. Kolb, JM., Wani, S.[2022]

Achieving complete remission of intestinal metaplasia (CRIM) after endoscopic eradication therapy (EET) significantly reduces the risk of dysplasia and advanced neoplasia recurrence compared to achieving only complete remission of dysplasia (CR-D), with a risk ratio of 2.8 for dysplasia recurrence after CR-D.

In a systematic review of 40 studies involving 4410 patients, the cumulative incidence of dysplasia recurrence was 5% after CRIM and 12% after CR-D, highlighting the importance of targeting CRIM as the primary goal of EET for dysplastic Barrett's esophagus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persistent intestinal metaplasia after endoscopic eradication therapy of neoplastic Barrett's esophagus increases the risk of dysplasia recurrence: meta-analysis. Sawas, T., Alsawas, M., Bazerbachi, F., et al.[2019]

In a study of 4114 Barrett's esophagus patients undergoing endoscopic eradication therapy (EET), the overall incidence of esophageal adenocarcinoma (EAC) was low at 6.01 per 1000 person-years, particularly among patients with high-grade dysplasia (HGD) where it was 12.9 per 1000 person-years.

The study also found that the all-cause mortality rate was 13.23 per 1000 person-years, with the highest rates in patients already diagnosed with EAC (25.1 per 1000 person-years), and the need for esophagectomy was less than 1% across all dysplasia grades, indicating a favorable safety profile for EET in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of Esophageal Adenocarcinoma, Mortality, and Esophagectomy in Barrett's Esophagus Patients Undergoing Endoscopic Eradication Therapy. Smith, ZL., Thorgerson, AM., Dawson, AZ., et al.[2023]

In a study of 623 patients with Barrett's esophagus undergoing endoscopic eradication therapy (EET), the average number of sessions required to achieve complete eradication of intestinal metaplasia (CE-IM) was found to be approximately 2.9, with 73% of patients achieving CE-IM after three sessions.

Age and the length of Barrett's esophagus were identified as significant predictors of incomplete response to EET, suggesting that alternative therapies may be necessary for patients who do not respond adequately after three sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Threshold evaluation for optimal number of endoscopic treatment sessions to achieve complete eradication of Barrett's metaplasia. Mittal, C., Muthusamy, VR., Simon, VC., et al.[2022]

Endoscopic eradication therapy is effective for treating Barrett's esophagus (BE) related neoplasia, but patients still need regular surveillance due to the risk of recurrence, with emerging evidence suggesting less frequent exams in the first year after successful treatment.

Future management may benefit from targeted biopsies and new technologies, such as biomarkers and personalized surveillance intervals, to improve efficiency and patient outcomes in monitoring for BE recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Post Ablative Barrett's Esophagus: a Review of Current Practices and Look at Emerging Technologies. Davis, C., Kolb, JM.[2023]

Endoscopic eradication therapy, particularly radiofrequency ablation (RFA), has shown excellent effectiveness in eradicating dysplasia in Barrett's esophagus, but there is a risk of recurrence, especially at the gastroesophageal junction, influenced by factors like the length of Barrett's segments and ongoing gastroesophageal reflux.

Recent advancements include combining RFA with endoscopic mucosal resection and new cost-effectiveness data indicating that RFA is economically viable for treating high-grade and low-grade dysplasia, but not for nondysplastic Barrett's esophagus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic eradication therapy for mucosal neoplasia in Barrett's esophagus. Dunbar, KB.[2018]

Endoscopic eradication therapy (EET) is a cost-effective treatment for patients with low and high grade dysplasia in Barrett's oesophagus, with an incremental cost-effectiveness ratio of £3006 per quality adjusted life year (QALY) gained.

The analysis indicates that EET becomes increasingly cost-effective over time, with a projected financial impact of £7.1 million on the UK National Health Service over five years, supporting its implementation based on updated guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cost-effectiveness analysis of endoscopic eradication therapy for management of dysplasia arising in patients with Barrett's oesophagus in the United Kingdom. Pollit, V., Graham, D., Leonard, C., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9275014/

Endoscopic eradication therapy for Barrett's oesophagus Several studies have demonstrated the efficacy and safety of endoscopic eradication therapy (EET) for the management of Barrett's oesophagus related neoplasia.

2. gastrojournal.org gastrojournal.org/article/S0016-5085(24)00302-0/fulltext

AGA Clinical Practice Guideline on Endoscopic Eradication ... Recurrence of Barrett's esophagus is rare following endoscopic eradication therapy coupled with effective reflux control. Am J Gastroenterol. 2017; 112:556 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0016510725000501?via%3Dihub

Long-term outcomes after endoscopic eradication therapy ... Long-term outcomes after endoscopic eradication therapy for dysplastic and T1a adenocarcinoma–related Barrett's esophagus: higher rate of late dysplastic ...

4. giejournal.org giejournal.org/article/S0016-5107(22)00121-3/fulltext

Endoscopic eradication therapy for Barrett's esophagus– ... EMR before RFA increased the likelihood of rescue EMR from 17.2% to 41.7% but did not affect the rate of CR-D, whereas rescue EMR after RFA ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29269998/

Endoscopic Eradication Therapy in Barrett's Esophagus Case volume at both the endoscopist and center level has been shown to impact clinical outcomes based on limited data. As a result, some ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0016510723003097

Real-world evidence of safety and effectiveness of Barrett's ... Endoscopic therapy is associated with a significantly lower 3-year mortality; however, it leads to esophageal strictures in 6.5% of treated patients. Graphical ...

7. tigejournal.org tigejournal.org/article/S1096-2883(17)30052-9/abstract

Endoscopic eradication therapy in Barrett's esophagus Efficacy and safety outcomes of multimodal endoscopic eradication therapy in Barrett's esophagus-related neoplasia: a systematic review and pooled-analysis.

8. giejournal.org giejournal.org/article/S0016-5107(16)30591-0/abstract

Efficacy and safety outcomes of multimodal endoscopic ... Patients undergoing s-EMR also showed high BE eradication rates (CE-N, 94.9%; CE-IM, 79.6%) but a higher rate of adverse events (strictures in 33.5%, bleeding ...