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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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). 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.
Primary Outcome
Number of subjects with Non-dysplastic, low grade dysplasia, high grade dysplasia and T1a early esophageal adenocarcinoma. As measured by using the BE dysplasia grading system of Non-dysplastic (no cancerous tissue present), low-grade dysplasia (minor cell changes found), high-grade dysplasia (extensive cell changes found, but not yet cancer), and noninvasive cancer (T1a early esophageal adenocarcinoma)
Interventions
- DRUG Budesonide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2014-02 |
| Est. Completion | 2019-01-11 |
| Phase | Phase 2 |
What the finished NCT02069847 record still lists
NCT02069847 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 1 intervention - of which Budesonide is the first listed.
NCT02069847 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02069847's enrollment target sits among peer trials
90 772nd of 2000 higher than 1,199 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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