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

• ClinicalTrials.gov Identifier: NCT04698668
• Recruitment Status: Completed
• First Posted: January 7, 2021
• Last Update Posted: March 3, 2021
• Sponsor: Arcispedale Santa Maria Nuova-IRCCS
• Information provided by (Responsible Party): Paolo Cecinato, Arcispedale Santa Maria Nuova-IRCCS

Study Description

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.

Condition or disease	Intervention/treatment
Pseudocyst; Walled Off Cavity	Device: fusion imaging

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 Design

• Study Type: Observational
• Actual Enrollment: 35 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Fusion Radiology in Interventional Endoscopy (FRIEnd) Approach for Pancreatic Fluid Collections
• Actual Study Start Date: February 12, 2020
• Actual Primary Completion Date: June 12, 2020
• Actual Study Completion Date: June 12, 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
1; Patients with pancreatic fluid collection treated with traditional EUS-drainage
2; Patients with pancreatic fluid collection treated with fusion imaging	Device: fusion imaging; To drain a pancreatic fluid collection through the assitance of the CT-scan image that is superimposed on the radiological field

Outcome Measures

Primary Outcome Measures :

1. clinical and radiological resolution of the PFC [ Time Frame: 12 months ]
   complete emtying of the PFC tighter with resolution of patients' symptomps
2. time of radiological resolution [ Time Frame: 12 months ]
   time taken for the complete emtying of the PFC

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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

Criteria

Inclusion Criteria:

• patients with post-pancreatitis PCF endoscopically drained

Exclusion Criteria:

• refuse to sign the informed consent

Contacts and Locations

Locations

Italy

IRCCS-AUSL Reggio Emilia

Reggio Emilia, RE, Italy

Sponsors and Collaborators

Arcispedale Santa Maria Nuova-IRCCS

Investigators

• Study Director: Romano Sassatelli; IRCCS-AUSL Reggio Emilia

More Information

Publications of Results:

Rajagopal M, Venkatesan AM. Image fusion and navigation platforms for percutaneous image-guided interventions. Abdom Radiol (NY). 2016 Apr;41(4):620-8. doi: 10.1007/s00261-016-0645-7. Review.

Zhang H, Chen GY, Xiao L, Ma X, Shi L, Wang T, Yan HT, Zou H, Chen Q, Tang LJ, Liu WH. Ultrasonic/CT image fusion guidance facilitating percutaneous catheter drainage in treatment of acute pancreatitis complicated with infected walled-off necrosis. Pancreatology. 2018 Sep;18(6):635-641. doi: 10.1016/j.pan.2018.06.004. Epub 2018 Jun 18.

Other Publications:

Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.

Arvanitakis M, Dumonceau JM, Albert J, Badaoui A, Bali MA, Barthet M, Besselink M, Deviere J, Oliveira Ferreira A, Gyökeres T, Hritz I, Hucl T, Milashka M, Papanikolaou IS, Poley JW, Seewald S, Vanbiervliet G, van Lienden K, van Santvoort H, Voermans R, Delhaye M, van Hooft J. Endoscopic management of acute necrotizing pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) evidence-based multidisciplinary guidelines. Endoscopy. 2018 May;50(5):524-546. doi: 10.1055/a-0588-5365. Epub 2018 Apr 9.

ASGE Standards of Practice Committee, Early DS, Acosta RD, Chandrasekhara V, Chathadi KV, Decker GA, Evans JA, Fanelli RD, Fisher DA, Fonkalsrud L, Hwang JH, Jue TL, Khashab MA, Lightdale JR, Muthusamy VR, Pasha SF, Saltzman JR, Sharaf RN, Shergill AK, Cash BD. Adverse events associated with EUS and EUS with FNA. Gastrointest Endosc. 2013 Jun;77(6):839-43. doi: 10.1016/j.gie.2013.02.018.

• Responsible Party: Paolo Cecinato, MD, Arcispedale Santa Maria Nuova-IRCCS
• ClinicalTrials.gov Identifier: NCT04698668
• Other Study ID Numbers: GASTRO.04.2020
• First Posted: January 7, 2021
• Last Update Posted: March 3, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No