NCT04698668

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
• Phase: —
• Study type: Observational
• Enrollment: 35 (actual)
• Sponsor: Azienda USL Reggio Emilia - IRCCS · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pseudocyst
• Walled Off Cavity

Interventions

Type	Name	Description
DEVICE	fusion imaging	To drain a pancreatic fluid collection through the assitance of the CT-scan image that is superimposed on the radiological field

Timeline

• Start date: 2020-02-12
• Primary completion: 2020-06-12
• Completion: 2020-06-12
• First posted: 2021-01-07
• Last updated: 2025-06-25

Locations

1 site across 1 country: Italy