Evaluation of the Outcomes and Performances of the Application of Augmented Reality in Operative Digestive Endoscopy
Fusion Radiology in Interventional Endoscopy (FRIEnd) Approach for Pancreatic Fluid Collections
| Sponsors |
Lead Sponsor: Arcispedale Santa Maria Nuova-IRCCS |
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| Source | Arcispedale Santa Maria Nuova-IRCCS | ||||||
| Brief Summary | 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 we have been using a new digital angiographic system (Discovery IGS 40, General Electrics) in biliopancreatic endoscopy, 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. |
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| Detailed Description | 17 drainages performed with traditional radiology (group 1) were retrospectively compared with 14 ones achieved with the fusion approach (group 2). The two population were homogenous for age, sex, pancreatitis etiology and indication for drainage whereas PFCs of group 2 were larger (663 cm3 vs 437 cm3), more frequently WON than pseudocysts and were treated more precociously. As for procedure, in the group 2, thanks to fusion imaging, we didn't need ever contrast media - that was pivotal with traditional radiology - to adequately define lesion morphology. LAMS (Axios) stents were placed mainly in group 2, while in group 1 other types of stent were used. |
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| Overall Status | Completed | ||||||
| Start Date | February 12, 2020 | ||||||
| Completion Date | June 12, 2020 | ||||||
| Primary Completion Date | June 12, 2020 | ||||||
| Study Type | Observational | ||||||
| Primary Outcome |
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| Enrollment | 35 | ||||||
| Condition | |||||||
| Intervention |
Intervention Type: Device Intervention Name: fusion imaging Description: To drain a pancreatic fluid collection through the assitance of the CT-scan image that is superimposed on the radiological field Arm Group Label: 2 |
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| Eligibility |
Sampling Method: Non-Probability Sample
Criteria:
Inclusion Criteria: - patients with post-pancreatitis PCF endoscopically drained Exclusion Criteria: - refuse to sign the informed consent Gender: All Minimum Age: 18 Years Maximum Age: N/A Healthy Volunteers: No |
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| Overall Official |
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| Location |
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| Location Countries |
Italy |
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| Verification Date |
January 2021 |
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| Responsible Party |
Type: Principal Investigator Investigator Affiliation: Arcispedale Santa Maria Nuova-IRCCS Investigator Full Name: Paolo Cecinato Investigator Title: Dr. Paolo Cecinato |
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| Has Expanded Access | No | ||||||
| Arm Group |
Label: 1 Description: Patients with pancreatic fluid collection treated with traditional EUS-drainage Label: 2 Description: Patients with pancreatic fluid collection treated with fusion imaging |
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| Patient Data | Undecided | ||||||
| Study Design Info |
Observational Model: Cohort Time Perspective: Retrospective |
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