RecruitingNCT04813055

Prospective Registry Of Therapeutic EndoscopiC ulTrasound


Sponsor

Paolo Giorgio Arcidiacono, MD

Enrollment

510 participants

Start Date

Dec 1, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

This registry aims to analyze long-term outcomes of therapeutic EUS (T-EUS) procedures, as well as to describe clinical and technical variables potentially predicting clinical success or adverse events, for a better selection of ideal candidates.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • subjects candidate to therapeutic EUS (T-EUS) procedures for any underlying disease
  • years old or older
  • able to provide an informed consent to inclusion.

Exclusion Criteria3

  • age \< 18 years
  • inability or unwillingness to sign the informed consent form (ICF)
  • contra-indication for endoscopy or use of fluoroscopy

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Interventions

PROCEDURETherapeutic 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

PROCEDUREPercutaneous Procedures

Procedures involving a percutaneous access to a target region (fluid collection, gallbladder, biliary tree)

PROCEDURESurgical Interventions

Surgical interventions to obtain a drainage (e.g. surgical necrosectomy, pancreatico-gastrostomy) or the bypass of a stricture (hepatico-jejunostomy or gastro-jejunostomy)

PROCEDUREnon-EUS-based endoscopic procedures

Other endoscopic procedures not involving EUS (enteral stenting, Enteroscopy-assisted ERCP)


Locations(1)

IRCCS San Raffaele Scientific Institute

Milan, Italy

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NCT04813055


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