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

NCT ID: NCT04698668

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-12

Study Completion Date

2020-06-12

Brief Summary

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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

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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.

Conditions

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Pseudocyst Walled Off Cavity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

Patients with pancreatic fluid collection treated with traditional EUS-drainage

No interventions assigned to this group

2

Patients with pancreatic fluid collection treated with fusion imaging

fusion imaging

Intervention Type DEVICE

To drain a pancreatic fluid collection through the assitance of the CT-scan image that is superimposed on the radiological field

Interventions

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fusion imaging

To drain a pancreatic fluid collection through the assitance of the CT-scan image that is superimposed on the radiological field

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients with post-pancreatitis PCF endoscopically drained

Exclusion Criteria

* refuse to sign the informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Romano Sassatelli

Role: STUDY_DIRECTOR

IRCCS-AUSL Reggio Emilia

Locations

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IRCCS-AUSL Reggio Emilia

Reggio Emilia, RE, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 29954676 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23100216 (View on PubMed)

Arvanitakis M, Dumonceau JM, Albert J, Badaoui A, Bali MA, Barthet M, Besselink M, Deviere J, Oliveira Ferreira A, Gyokeres 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.

Reference Type BACKGROUND
PMID: 29631305 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26826086 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 23684089 (View on PubMed)

Other Identifiers

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GASTRO.04.2020

Identifier Type: -

Identifier Source: org_study_id

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