N/A
N=26
Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management
Esophageal Dilation · Refractory Benign Esophageal Stricture
Bottom Line
View on ClinicalTrials.gov: NCT03738566 ↗Enrolled (actual)
26
Serious AEs
3.2%
Results posted
May 2023
Primary outcome: Primary: Number of Endoscopic Interventions — 12; 11; 12; 7 endoscopies
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Esophageal self-dilation therapy (Device); Endoscopic therapy with esophageal dilation (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Endoscopic Interventions |
12; 11; 12; 7 | — |
| SECONDARY Length of Days Intervention Free |
7; 82; 147 | — |
| SECONDARY Mayo Dysphagia Questionnaire (MDQ-30) at Baseline |
7.16; 7.56; 5.36 | — |
| SECONDARY Mayo Dysphagia Questionnaire (MDQ-30) at 12 Months |
5.55; 5.83; 5.17 | — |
| SECONDARY Clinically Significant Adverse Events |
0; 0; 0; 1 | — |
Summary
This study is being done to see which treatment is more effective in improving the difficulty of swallowing. Researchers are comparing self-dilation to endoscopic dilation.
Eligibility Criteria
Inclusion Criteria
- Refractory benign esophageal stricture defined as an esophageal stricture with persistent dysphagia despite undergoing 5 endoscopic dilations within a 1 year period. Persistent dysphagia will be considered if patients has solid food dysphagia at least once a week
Exclusion Criteria
- Patient with malignant esophageal stricture
- Angulated stricture which prevents safe passage of Maloney dilator in office setting
- In ability to achieve an esophageal diameter of 10 mm with endoscopic dilation
- Known significant esophageal motor disorder (i.e. achalasia, aperistalsis, functional obstruction, jackhammer, distal esophageal spasm)*
- The presence of esophageal stent
- Inability to learn self-dilation secondary to blindness or cognitive dysfunction
- Use of chronic anticoagulants
Data sourced from ClinicalTrials.gov (NCT03738566). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.