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

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.

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.

Overall Status Completed
Start Date February 12, 2020
Completion Date June 12, 2020
Primary Completion Date June 12, 2020
Study Type Observational
Primary Outcome
Measure Time Frame
clinical and radiological resolution of the PFC 12 months
time of radiological resolution 12 months
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

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

Overall Official
Last Name Role Affiliation
Romano Sassatelli Study Director IRCCS-AUSL Reggio Emilia
Location
Facility: IRCCS-AUSL Reggio Emilia
Location Countries

Italy

Verification Date

January 2021

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Arcispedale Santa Maria Nuova-IRCCS

Investigator Full Name: Paolo Cecinato

Investigator Title: Dr. Paolo Cecinato

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

Patient Data Undecided
Study Design Info

Observational Model: Cohort

Time Perspective: Retrospective

Source: ClinicalTrials.gov