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Evaluation of the Outcomes and Performances of the Application of Augmented Reality in Operative Digestive Endoscopy

A

Azienda USL Reggio Emilia - IRCCS

Status

Completed

Conditions

Pseudocyst
Walled Off Cavity

Treatments

Device: fusion imaging

Study type

Observational

Funder types

Other

Identifiers

NCT04698668
GASTRO.04.2020

Details and patient eligibility

About

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.

Full 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.

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients with post-pancreatitis PCF endoscopically drained

Exclusion criteria

  • refuse to sign the informed consent

Trial design

35 participants in 2 patient groups

1
Description:
Patients with pancreatic fluid collection treated with traditional EUS-drainage
2
Description:
Patients with pancreatic fluid collection treated with fusion imaging
Treatment:
Device: fusion imaging

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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