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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04698668
Enrollment
35
Registered
2021-01-07
Start date
2020-02-12
Completion date
2020-06-12
Last updated
2025-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pseudocyst, Walled Off Cavity

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 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.

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, endoscopists 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.

Interventions

To drain a pancreatic fluid collection through the assitance of the CT-scan image that is superimposed on the radiological field

Sponsors

Azienda USL Reggio Emilia - IRCCS
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients with post-pancreatitis PCF endoscopically drained

Exclusion criteria

* refuse to sign the informed consent

Design outcomes

Primary

MeasureTime frameDescription
clinical and radiological resolution of the PFC12 monthscomplete emtying of the PFC tighter with resolution of patients' symptomps
time of radiological resolution12 monthstime taken for the complete emtying of the PFC

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026