NCT04698668

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
Last Updated

June 25, 2025

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

January 5, 2021

Last Update Submit

June 20, 2025

Conditions

PseudocystWalled Off Cavity

Outcome Measures

Primary Outcomes (2)

  • clinical and radiological resolution of the PFC

    complete emtying of the PFC tighter with resolution of patients' symptomps

    12 months

  • time of radiological resolution

    time taken for the complete emtying of the PFC

    12 months

Study Arms (2)

1

Patients with pancreatic fluid collection treated with traditional EUS-drainage

2

Patients with pancreatic fluid collection treated with fusion imaging

Device: fusion imaging

Interventions

fusion imagingDEVICE

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

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient affected by moderate-severe pancreatits whio develops a PFC (WON or pseudocysts) that requires an endoscopic drainage

You may qualify if:

  • patients with post-pancreatitis PCF endoscopically drained

You may not qualify if:

  • refuse to sign the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS-AUSL Reggio Emilia

Reggio Emilia, RE, Italy

Location

Related Publications (5)

  • 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.

    PMID: 23100216BACKGROUND

  • 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.

    PMID: 29631305BACKGROUND

  • 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.

    PMID: 26826086BACKGROUND

  • 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.

    PMID: 29954676BACKGROUND

  • 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.

    PMID: 23684089BACKGROUND

Study Officials

  • Romano Sassatelli

    IRCCS-AUSL Reggio Emilia

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2021

First Posted

January 7, 2021

Study Start

February 12, 2020

Primary Completion

June 12, 2020

Study Completion

June 12, 2020

Last Updated

June 25, 2025

Record last verified: 2021-02

Locations

IT(1)