Prospective Registry Of Therapeutic EndoscopiC ulTrasound
NCT ID: NCT04813055
Last Updated: 2024-12-27
Study Results
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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RECRUITING
510 participants
OBSERVATIONAL
2020-12-01
2026-12-01
Brief Summary
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Detailed Description
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For the purpose of this registry, the following procedures will be considered to be T-EUS procedures:
* EUS-guided collection drainage
* EUS-guided biliary drainage
* EUS-guided gallbladder drainage
* EUS-guided gastro-enterostomy
* EUS-directed ERCP
* EUS-guided pancreatic duct drainage
Each patient will be assigned to a procedure following standard clinical practice, in most instances following a routinely multidisciplinary discussion.
All patients eligible for the abovementioned clinical indications, but finally undergoing alternative procedures (e.g. surgical interventions, percutaneous interventions or other endoscopic procedures) will be proposed to be enrolled in the registry as "controls". The same variables will be collected, with the exception of technical variables related to the EUS-guided intervention.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Therapeutic EUS
Procedures involving Linear Echoendoscopes to create a communication between the gastrointestinal tract and a target organ (biliary tree, pancreatic duct, fluid collection, gallbladder, downstream gastrointestinal tract) through plastic or metal stents.
Therapeutic EUS
1. EUS-guided collection drainage (transgastric or transduodenal, performed by Lumen Apposing Metal Stents or double pigtail stents) and eventual endoscopic necrosectomy
2. EUS-guided biliary drainage (either of the extrahepatic or intrahepatic biliary tree / transduodenal or transgastric / either as access for subsequent rendez-vous or transpapillary stenting OR for transparietal stenting by metal or plastic stents).
3. EUS-guided gallbladder drainage via Lumen Apposing Metal Stents and eventual subsequent EUS-based cholecystolithotomy
4. EUS-guided gastro-jejunostomy through Lumen Apposing Metal Stents
5. EUS-directed ERCP in post-surgical anatomy (by gastro-gastrostomy or entero-enterostomy performed through Lumen Apposing Metal Stents)
6. EUS-guided pancreatic duct drainage
Controls
Patients eligible for T-EUS procedures, but undergoing alternative surgical interventions, percutaneous interventions (e.g. Percutaneous Biliary Drainage) or non-EUS based endoscopic procedures (e.g. enteral stenting)
Percutaneous Procedures
Procedures involving a percutaneous access to a target region (fluid collection, gallbladder, biliary tree)
Surgical Interventions
Surgical interventions to obtain a drainage (e.g. surgical necrosectomy, pancreatico-gastrostomy) or the bypass of a stricture (hepatico-jejunostomy or gastro-jejunostomy)
non-EUS-based endoscopic procedures
Other endoscopic procedures not involving EUS (enteral stenting, Enteroscopy-assisted ERCP)
Interventions
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Therapeutic EUS
1. EUS-guided collection drainage (transgastric or transduodenal, performed by Lumen Apposing Metal Stents or double pigtail stents) and eventual endoscopic necrosectomy
2. EUS-guided biliary drainage (either of the extrahepatic or intrahepatic biliary tree / transduodenal or transgastric / either as access for subsequent rendez-vous or transpapillary stenting OR for transparietal stenting by metal or plastic stents).
3. EUS-guided gallbladder drainage via Lumen Apposing Metal Stents and eventual subsequent EUS-based cholecystolithotomy
4. EUS-guided gastro-jejunostomy through Lumen Apposing Metal Stents
5. EUS-directed ERCP in post-surgical anatomy (by gastro-gastrostomy or entero-enterostomy performed through Lumen Apposing Metal Stents)
6. EUS-guided pancreatic duct drainage
Percutaneous Procedures
Procedures involving a percutaneous access to a target region (fluid collection, gallbladder, biliary tree)
Surgical Interventions
Surgical interventions to obtain a drainage (e.g. surgical necrosectomy, pancreatico-gastrostomy) or the bypass of a stricture (hepatico-jejunostomy or gastro-jejunostomy)
non-EUS-based endoscopic procedures
Other endoscopic procedures not involving EUS (enteral stenting, Enteroscopy-assisted ERCP)
Eligibility Criteria
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Inclusion Criteria
* 18 years old or older
* able to provide an informed consent to inclusion.
Exclusion Criteria
* inability or unwillingness to sign the informed consent form (ICF)
* contra-indication for endoscopy or use of fluoroscopy
18 Years
ALL
No
Sponsors
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Paolo Giorgio Arcidiacono, MD
OTHER
Responsible Party
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Paolo Giorgio Arcidiacono, MD
Prof. Dr.
Principal Investigators
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Paolo Giorgio Arcidiacono, MD, FASGE
Role: PRINCIPAL_INVESTIGATOR
IRCCS San Raffaele Scientific Institute
Locations
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IRCCS San Raffaele Scientific Institute
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Giuseppe Vanella, MD
Role: primary
References
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DeWitt JM, Arain M, Chang KJ, Sharaiha R, Komanduri S, Muthusamy VR, Hwang JH; AGA Center for GI Innovation and Technology. Interventional Endoscopic Ultrasound: Current Status and Future Directions. Clin Gastroenterol Hepatol. 2021 Jan;19(1):24-40. doi: 10.1016/j.cgh.2020.09.029. Epub 2020 Sep 18.
Teoh AYB, Dhir V, Kida M, Yasuda I, Jin ZD, Seo DW, Almadi M, Ang TL, Hara K, Hilmi I, Itoi T, Lakhtakia S, Matsuda K, Pausawasdi N, Puri R, Tang RS, Wang HP, Yang AM, Hawes R, Varadarajulu S, Yasuda K, Ho LKY. Consensus guidelines on the optimal management in interventional EUS procedures: results from the Asian EUS group RAND/UCLA expert panel. Gut. 2018 Jul;67(7):1209-1228. doi: 10.1136/gutjnl-2017-314341. Epub 2018 Feb 20.
Vanella G, Leone R, Frigo F, Bronswijk M, van Wanrooij RLJ, Tamburrino D, Orsi G, Belfiori G, Macchini M, Reni M, Aldrighetti L, Falconi M, Capurso G, van der Merwe S, Arcidiacono PG. Endoscopic ultrasound-guided choledochoduodenostomy versus hepaticogastrostomy combined with gastroenterostomy in malignant double obstruction (CABRIOLET_Pro): A prospective comparative study. DEN Open. 2024 Oct 6;5(1):e70024. doi: 10.1002/deo2.70024. eCollection 2025 Apr.
Other Identifiers
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178/INT/2020
Identifier Type: -
Identifier Source: org_study_id