Pseudocyst Clinical Trial
Official title:
Fusion Radiology in Interventional Endoscopy (FRIEnd) Approach for Pancreatic Fluid Collections
| Verified date | February 2021 |
| Source | Arcispedale Santa Maria Nuova-IRCCS |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Virtual reality obtained by the fusion of images can be applied to several fields of medicine leading to the so called "augmented reality". Since 2017 investigators have been using a new digital angiographic system (Discovery IGS 40, General Electrics), where fluoroscopy can be fused with pre-procedural CT o MRI. Specifically the present study aimed at verifying the advantages that fusion imaging could bring in EUS-guided drainage of post-pancreatitis fluid collection (PFC), i.e. pseudocysts or WON, in terms of more appropriate visualization, drainage approach and time needed for resolution.
| Status | Completed |
| Enrollment | 35 |
| Est. completion date | June 12, 2020 |
| Est. primary completion date | June 12, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - patients with post-pancreatitis PCF endoscopically drained Exclusion Criteria: - refuse to sign the informed consent |
| Country | Name | City | State |
|---|---|---|---|
| Italy | IRCCS-AUSL Reggio Emilia | Reggio Emilia | RE |
| Lead Sponsor | Collaborator |
|---|---|
| Arcispedale Santa Maria Nuova-IRCCS |
Italy,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | clinical and radiological resolution of the PFC | complete emtying of the PFC tighter with resolution of patients' symptomps | 12 months | |
| Primary | time of radiological resolution | time taken for the complete emtying of the PFC | 12 months |