Endoscopic Stenting for Benign Esophageal Strictures

(RBES Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Pregnancy, Radiation therapy, Esophagitis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks for stent placement followed by variable duration of dilations

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two treatments for benign esophageal strictures, which are non-cancerous narrowings of the esophagus that make swallowing difficult. One group will receive frequent esophageal dilations (widening) and a stent (a tube to keep the esophagus open) if needed, while the other group will start with a stent and then receive dilations. The goal is to determine which method better helps patients manage their symptoms. Suitable candidates are those with a confirmed non-cancerous esophageal stricture who have difficulty swallowing food. As an unphased trial, this study allows patients to contribute to research that could enhance treatment options for esophageal strictures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that esophageal stenting is safe for managing benign esophageal strictures?

Research has shown that esophageal stents are generally safe for patients, though mild side effects can occur. Most side effects are minor and manageable with proper care. For instance, one study found that while most patients experienced some side effects, they were usually minor and could be handled with the right support and guidance.

The success rate of placing these stents is high, at about 96.4%, meaning doctors can successfully place the stents in nearly all cases. The treatment's effectiveness over time is also promising. After four weeks, the success rate reaches 100%, indicating all patients benefited. At 12 weeks, about 69.23% of patients continued to do well, and at one year, 72.72% maintained their improvement.

Overall, while some side effects exist, esophageal stents are generally well-tolerated and effective for treating esophageal strictures, which is the narrowing of the esophagus. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using esophageal stents for benign esophageal strictures because they offer a potentially more efficient option compared to the standard repeated dilation method. Typically, treatments involve dilating the esophagus multiple times, which can be uncomfortable and time-consuming. The unique feature of the stent approach is its ability to maintain esophageal opening more consistently, either by placing the stent early in the treatment process or after several dilations. This could mean fewer procedures and less frequent interventions, making life easier for patients while ensuring the esophagus stays open effectively.

What evidence suggests that esophageal stenting is effective for benign esophageal strictures?

Research has shown that esophageal stents can help treat benign esophageal strictures, a narrowing of the esophagus. In this trial, participants will be assigned to either the late-stent approach or the early-stent approach. Studies indicate that after placing a temporary stent, up to 40% of patients no longer experience swallowing difficulties and require no further treatment. Specifically, one study found that nearly 70% of patients had successful results after 12 weeks. Both dilation and stenting can be effective, with the choice depending on each patient's response. These findings suggest that esophageal stents are a promising option for managing this condition. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals with non-cancerous narrowings in their esophagus that haven't improved with stretching procedures. Specific eligibility details are not provided, but typically participants must meet certain health standards and have a history of the condition being studied.

Inclusion Criteria

I have moderate to severe difficulty swallowing.

Able to give informed and written consent

I am healthy enough for an upper GI endoscopy procedure.

Exclusion Criteria

Previous esophageal stent tried over 2 months ago

Significant comorbidities making patient high risk for upper GI endoscopy

Cannot keep follow up appointments as per protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either early or late stent placement followed by dilations

2 weeks for stent placement followed by variable duration of dilations

Weekly visits for dilations

Follow-up

Participants are monitored for safety and effectiveness after treatment to maintain esophageal diameter

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Esophageal Stent

Trial Overview

The study compares two approaches to treat stubborn esophageal strictures: one involves repeated stretching followed by stent placement if unsuccessful, while the other uses early stent insertion followed by dilations as needed.

How Is the Trial Designed?

Group I: Late-stent approach Active Control 1 Intervention

Repeated dilations at weekly intervals, and based on the response, the intervals between dilations are adjusted, and if still no response, place a removable FCSEMS (18 mm diameter). The stent will be removed in 2 weeks followed again by weekly dilations till less than one dilation is needed every 3 months to maintain a luminal diameter of 14 mm or more.

Group II: Early-stent approach Active Control 1 Intervention

Removable FCSEMS (18 mm diameter) placed on index endoscopy and removed after 2 weeks followed by weekly dilations till less than one dilation is needed every 3 months to maintain a luminal diameter of 14 mm or more.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4325310/

Clinical outcomes of self-expandable stent placement for ...

The overall clinical success rate was 24.2% and according to stent type 14.1% for FC SEMS, 32.9% for BD stents and 27.1% for SEPS.

2.

academic.oup.com

academic.oup.com/jcag/article/8/Supplement_1/i16/7998199

A41 OUTCOMES FROM ESOPHAGEAL STENT PLACEMENT ...

12 patients received a total of 32 esophageal stents for RBES. 50.0% of patients had peptic strictures. 33.3% of patients had anastomotic ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2590030720300982

Stents for benign esophageal strictures

After temporary stent placement, 40% of patients have a complete resolution of dysphagia requiring no additional therapy. However, this should be traded-off ...

4.

bmcgastroenterol.biomedcentral.com

bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-019-1006-0

The role of endoscopic dilation and stents in refractory benign ...

Current research confirms that both dilation and stents for RBES are effective, but literature is scarce on the clinical efficacy of dilation versus stents.

5.

ijgii.org

ijgii.org/journal/view.html?doi=10.18528/ijgii210029

Safety and efficacy of esophageal stents for ...

The technical success rate was 96.4%. The clinical success rates at 4 weeks, 12 weeks, and 1 year were 100%, 69.23%, and 72.72%, respectively.

6.

nature.com

nature.com/articles/s41598-021-01921-z

Individually designed fully covered self-expandable metal ...

One study reported that the restenosis rate of a "Z" stent after esophageal stent placement was 27% in adult patients, while another study on ...