N/A
Completed N=36
A Study to Evaluate the Effectiveness and Safety of EUS-guided Transluminal Drainage With 'Niti-S SPAXUS Stent'
Pancreatic Pseudocyst
Source: ClinicalTrials.gov NCT02730663 ↗
Enrolled (actual)
36
Serious AEs
40.0%
Results posted
Jul 2019
Primary outcomePrimary: Number of Participants With Clinical Success — 33 participants — p=0.05
Summary
The purpose of this study is to evaluate the safety and effectiveness of endoscopic ultrasound (EUS)-guided transluminal drainage with 'Niti-S SPAXUS Stent' for the treatment of pancreatic pseudocyst.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical Success |
33 | 0.05 |
| SECONDARY Number of Participants With Technical Success |
33 | — |
| SECONDARY Number of Participants With Stent Lumen Patency |
34 | — |
| SECONDARY Number of Participants With Stent Removal Success |
34 | — |
| SECONDARY Procedure Time |
1074.88; 618.12 | — |
| SECONDARY Number of Participants With Procedural/Device Related Serious Adverse Events |
14 | — |
| SECONDARY Other Adverse Events |
154 | — |
Eligibility Criteria
Inclusion Criteria
- Pancreatic pseudocyst ≥6cm in size, with ≥70% fluid content that is eligible for transluminal drainage
- Patient willing to provide written informed consent and comply with follow-up requirements
Exclusion Criteria
- Ineligible for endoscopic intervention
- Pancreatic pseudocyst with severe internal septation
- Platelet count 1.5
- Hemodynamic instability (e.g. shock)
- Active infectious disease (e.g. endocarditis, meningitis)
- Participating in any other investigational drug or device clinical trial within past 3 months
- Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant
Data sourced from ClinicalTrials.gov (NCT02730663). 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. Informational only — not medical advice.