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

Completed

• Conditions: Walled Off Cavity; Pseudocyst
• Interventions: Device: fusion imaging

• Registration Number: NCT04698668
• Lead Sponsor: 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 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.

Study Timeline

• Study Start: 2020-02-12
• Primary Completion: 2020-06-12
• Study Completion: 2020-06-12
• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2021-01-06
• Study First Posted: 2021-01-07
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-28
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• patients with post-pancreatitis PCF endoscopically drained

Exclusion Criteria

• refuse to sign the informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2	fusion imaging	Patients with pancreatic fluid collection treated with fusion imaging

Primary Outcome Measures

Name	Time	Method
clinical and radiological resolution of the PFC	12 months	complete emtying of the PFC tighter with resolution of patients' symptomps
time of radiological resolution	12 months	time taken for the complete emtying of the PFC

Trial Locations

Locations (1)

IRCCS-AUSL Reggio Emilia; 🇮🇹 Reggio Emilia, RE, Italy