Stenting sooner may ease swallowing woes for esophageal stricture patients
NCT ID NCT06991049
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether placing a temporary stent early or only after repeated dilations works better for people with benign esophageal strictures that don't respond to standard treatment. Twenty adults with trouble swallowing will be followed for at least two years. The goal is to see which approach achieves and maintains a wider esophagus with fewer side effects and less recurrence.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fully covered self-expandable metal esophageal stent
- What this could lead to
- If successful, this could show that placing a stent earlier helps people with stubborn esophageal strictures swallow better and need fewer procedures.
- What could go wrong
- This is a small early-stage trial with only 20 participants, so results may not apply to everyone. Stents can cause discomfort, migration, or tissue overgrowth.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Oct 2025
- Expected to finish
-
Jul 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Able to give informed and written consent. * Able to keep follow up appointments as per protocol (minimum 2 years). * Biopsy proven benign esophageal stricture. * Dysphagia (grade 2 and above). * Fit to undergo upper GI endoscopy. * Documented esophageal stricture with a luminal diameter \<14 mm at index endoscopy. Exclusion Criteria: * Minimal dysphagia (grade 0-1) * Neuromuscular dysphagia (such as achalasia, oro-pharyngeal dysphagia post-stroke, crico-pharyngeal bar, Zenker diverticulum etc.) * Pregnant or planning to be pregnant during the study period. * Malignant or indeterminate esophageal stricture. * Actively receiving radiation therapy. * Persistent associated active esophagitis that has not yet healed. * Esophageal strictures associated with fistula/leaks/current or prior perforation. * Eosinophilic esophagitis. * Associated esophageal varices. * No other malignancy limiting life expectancy. * Patients in whom placing esophageal stents is not possible/contraindicated (such as high cervical esophageal strictures, active bleeding, metal allergy, tortuous esophagus, pseudodiverticulum with stricture). * Previous esophageal stent tried over 2 months ago * Significant comorbidities making patient high risk for upper GI endoscopy. * Unable to give informed consent. * Cannot keep follow up appointments as per protocol. * Procedures and stents not covered by patient's insurance. * Patients who, after comprehensive discussion and explanation of both the early-stent and late-stent approaches, choose to proceed with a specific approach and decline participation in randomization.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Refractory benign esophageal strictures are added.
Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Froedtert Hospital
RECRUITINGMilwaukee, Wisconsin, 53226, United States