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

Trial Summary

What is the purpose of this trial?

This project is being done to compare two current treatment clinical options for management of RBES: 1) Frequent dilations followed by temporary esophageal stent placement if dilations fail, or 2) Early stent placement followed by dilations

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+