Refractory Benign Esophageal StricturesRBESNCT06991049
Early Versus Late Endoscopic Stenting for Refractory Benign Esophageal Strictures
A study testing Fully covered self-expandable metal esophageal stent in people with Refractory Benign Esophageal Strictures, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Benign Esophageal Strictures
- What is being tested?
- Fully covered self-expandable metal esophageal stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2025to Jul 2027
- Phase
- Interventional
- 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
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
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, 1 recruiting
- Recruiting
Froedtert Hospital
Milwaukee, Wisconsin, 53226
Study Coordinator, 414-805-7372, sthierfe@mcw.edu
Kulwinder Dua, M.D.
About this study
Official title: Early Versus Late Endoscopic Temporary Stenting for Management of Refractory Benign Esophageal Strictures
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
Read the detailed description
This study aims to explore the safety and effectiveness of two clinical treatment approaches used to manage RBES patients-Temporary early-stent placement versus late stenting.
For normal swallowing, the esophagus (food pipe) lumen should be equal to or more than 14 mm in diameter. In those with stricture (narrowing) of the esophagus from benign causes, initial endoscopic management is serial sessions of dilation (stretching) to achieve and maintain a diameter of ≥14mm. Many strictures may not respond to this approach (refractory). Esophageal stents (18 mm - 23 mm diameter) temporarily placed for 2 weeks using an endoscope are also used dilate and remold the stricture. While in place, patients can swallow. This can save the patient from undergoing repeated dilations. Stents can be placed either late in the process of management after several traditional dilations have failed or early in the management to rapidly achieve a diameter of ≥14 mm and then continuing traditional dilations.
Although either of above two approaches can be used for the clinical management of RBES, in this study the investigators plan to randomly assign patients to start with one of the two approaches and compare outcomes.
- Conditions
- Refractory Benign Esophageal Strictures
- Being tested
- Fully covered self-expandable metal esophageal stent
- Keywords
- Refractory Benign Esophageal Strictures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fully covered self-expandable metal esophageal stentDevice
Esophageal stent placement for patients with benign esophageal strictures not responding to endoscopic dilations.
| Study group | Role | What they receive |
|---|---|---|
| Late-stent approach | Active comparator | 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. Receives: Device: Fully covered self-expandable metal esophageal stent |
| Early-stent approach | Active comparator | 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. Receives: Device: Fully covered self-expandable metal esophageal stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to achieve esophageal luminal diameter to ≥14 mm
The duration required to achieve and maintain an esophageal diameter of ≥14 mm using the two techniques.
Measured: From enrollment to follow up, up to 2 years
Secondary outcomes (2)
Adverse event rate
Measured: From enrollment to follow up, up to 2 years
Recurrence rate of esophageal stricture
Measured: From enrollment to follow up, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start14 Oct 2025
- Primary completion21 Mar 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Benign Esophageal StricturesStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kulwinder Dua, MD, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991049
- Sponsor's protocol ID
- PRO00054233
- Acronym
- RBES
- Status last verified
- Oct 2025
- First submitted
- 22 May 2025
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Late Endoscopic Temporary Stenting for Management of Refractory Benign Esophageal Strictures
- ClinicalTrials.gov ID
- NCT06991049
- Acronym / sponsor ID
- RBES / PRO00054233
- Conditions
- Refractory Benign Esophageal Strictures
- Keywords
- Refractory Benign Esophageal Strictures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 21 Mar 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 25 May 2025 (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.
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
Detailed description
This study aims to explore the safety and effectiveness of two clinical treatment approaches used to manage RBES patients-Temporary early-stent placement versus late stenting.
For normal swallowing, the esophagus (food pipe) lumen should be equal to or more than 14 mm in diameter. In those with stricture (narrowing) of the esophagus from benign causes, initial endoscopic management is serial sessions of dilation (stretching) to achieve and maintain a diameter of ≥14mm. Many strictures may not respond to this approach (refractory). Esophageal stents (18 mm - 23 mm diameter) temporarily placed for 2 weeks using an endoscope are also used dilate and remold the stricture. While in place, patients can swallow. This can save the patient from undergoing repeated dilations. Stents can be placed either late in the process of management after several traditional dilations have failed or early in the management to rapidly achieve a diameter of ≥14 mm and then continuing traditional dilations.
Although either of above two approaches can be used for the clinical management of RBES, in this study the investigators plan to randomly assign patients to start with one of the two approaches and compare outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Late-stent approach | Active comparator | Device: Fully covered self-expandable metal esophageal stentRepeated 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. |
| Early-stent approach | Active comparator | Device: Fully covered self-expandable metal esophageal stentRemovable 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fully covered self-expandable metal esophageal stentEsophageal stent placement for patients with benign esophageal strictures not responding to endoscopic dilations. | Device | Early-stent approach, Late-stent approach |
Primary outcome
Time to achieve esophageal luminal diameter to ≥14 mm
Time frame: From enrollment to follow up, up to 2 years
The duration required to achieve and maintain an esophageal diameter of ≥14 mm using the two techniques.
2 secondary outcomes
Adverse event rate
Time frame: From enrollment to follow up, up to 2 years
Recurrence rate of esophageal stricture
Time frame: From enrollment to follow up, up to 2 years
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 30 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Refractory Benign Esophageal Strictures
Enrolling by invitation
Adipose-derived Stem Cells in Treatment of Esophageal Strictures
Esophageal Stenosis Acquired
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fully covered self-expandable metal esophageal stent in people with Refractory Benign Esophageal Strictures, run by Medical College of Wisconsin 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 6 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 30 Oct 2025. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to achieve esophageal luminal diameter to ≥14 mm (time frame: From enrollment to follow up, up to 2 years). 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 30 Oct 2025.