Clinical trial NCT04698668: Evaluation of the Outcomes and Performances of the Application of Augmented Reality in Operative Digestive Endoscopy
Official title: Fusion Radiology in Interventional Endoscopy (FRIEnd) Approach for Pancreatic Fluid Collections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pseudocyst
Walled Off Cavity
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2021-01-07
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient affected by moderate-severe pancreatits whio develops a PFC (WON or pseudocysts) that requires an endoscopic drainage

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.

Eligibility criteria: Inclusion Criteria:

* patients with post-pancreatitis PCF endoscopically drained

Exclusion Criteria:

* refuse to sign the informed consent

Primary outcomes:
measure: clinical and radiological resolution of the PFC
timeFrame: 12 months
measure: time of radiological resolution
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: IRCCS-AUSL Reggio Emilia
state: RE
Study officials:
affiliation: IRCCS-AUSL Reggio Emilia
name: Romano Sassatelli
role: STUDY_DIRECTOR
References:
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