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NCT02069847 · ClinicalTrials.gov registry record · Phase 2
Prospective Evaluation of Budesonide for Prevention of Esophageal Strictures After Endotherapy
A Phase 2 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
NCT02069847: Completed Phase 2 study, sponsored by Mayo Clinic.
NCT02069847 is a Phase 2 study that has completed, run by Mayo Clinic. The registered enrollment target is 90 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02069847, a Phase 2 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
Study Summary
Surgery has been historically the mainstay treatment for advanced pre-malignant lesions and early esophageal cancers. However, esophagectomy is associated with significant morbidity and mortality. With the advance of therapeutic endoscopy, there has been a growing interest and application of endoscopic resection and mucosal ablative techniques for the treatment of these diseases. Esophageal stricture (ES) formation has become an increasingly recognized complication of extensive endoscopic mucosal ablation and/or resection. The resultant symptomatic stricture development can significantly impair a patient's quality of life. Endoscopic therapy of esophageal strictures with balloon dilation and/or local steroid injection is invasive, costly, and associated with the potential risk of perforation. Recently, oral corticosteroids have been introduced for the prevention of esophageal stricture after endoscopic submucosal dissection. Budesonide is a synthetic steroid with topical anti-inflammatory properties and high first-pass metabolism; thus, potentially less systemic absorption and side effects. Hypothesis: Oral budesonide prevents esophageal stricture formation in patients who underwent radical endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for advanced premalignant esophageal lesions or superficial esophageal cancers.
Interventions
- DRUG Budesonide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2014-02 |
| Est. Completion | 2019-01-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02069847
The ClinicalTrials.gov registry entry for NCT02069847 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Budesonide is the first listed.
NCT02069847 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02069847 about?
NCT02069847 is a clinical study titled "Prospective Evaluation of Budesonide for Prevention of Esophageal Strictures After Endotherapy". Surgery has been historically the mainstay treatment for advanced pre-malignant lesions and early esophageal cancers. However, esophagectomy is associated with significant morbidity and mortality. With the advance of therapeutic endoscopy, there has been a growing interest and application of endosco...
What is the current status of trial NCT02069847?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2014-02. Estimated completion is 2019-01-11.
What interventions are being tested in trial NCT02069847?
The interventions under investigation include: Budesonide (DRUG).
Who is sponsoring clinical trial NCT02069847?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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