N/A
N=20
Evaluation of Pancreatic Pseudocyst Drainage With a Metal Stent
Pancreatic Pseudocysts
Bottom Line
View on ClinicalTrials.gov: NCT01239056 ↗Enrolled (actual)
20
Serious AEs
10.0%
Results posted
Aug 2015
Primary outcome: Primary: Technical Success of Endoscopic Ultrasound-guided Single-access Pseudocyst Drainage With a Fully Covered Self-expanding Metal Stent ; Anchored With a Double Pigtail Plastic Stent Inserted Through the Metal Stent Lumen — 20; 0 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Endoscopy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Technical Success of Endoscopic Ultrasound-guided Single-access Pseudocyst Drainage With a Fully Covered Self-expanding Metal Stent ; Anchored With a Double Pigtail Plastic Stent Inserted Through the Metal Stent Lumen |
20; 0 | — |
| SECONDARY Resolution of Pancreatic Pseudocyst After Placement of Fully Covered Self-expanding Metal Stent (CSEMS). |
17; 3 | — |
| SECONDARY Adverse Events |
2; 1; 1 | — |
Summary
The purpose of this study is to study the evaluation of the effectiveness of endoscopic Pancreatic Pseudocyst drainage using a metal stent.
Eligibility Criteria
Inclusion Criteria
- Subject is 18 years or older
- Subject has pancreatic pseudocyst
- Subject has medical indication for drainage of the pancreatic pseudocyst
- Subject must be able to give informed consent
Exclusion Criteria
- Any contraindication to endoscopic pseudocyst drainage
- Subject is unable to give informed consent
Data sourced from ClinicalTrials.gov (NCT01239056). 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.