Clinical trial NCT04813055: Prospective Registry Of Therapeutic EndoscopiC ulTrasound
Official title: Prospective Registry Of Therapeutic EndoscopiC ulTrasound
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Outlet Obstruction
Biliary Obstruction
Acute Pancreatic Fluid Collection
Acute Pancreatitis With Infected Necrosis
Acute Cholecystitis
Chronic Pancreatitis
Keywords: Endoscopic ultrasound
Therapeutic EUS
Interventional EUS
Biliary Drainage
Gastro-jejunostomy
Gallbladder Drainage
Endoscopy
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive patients referred for any condition treatable by therapeutic EUS procedures, benign or malignant, as first intention or after failure of other procedures.

Brief 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.

Detailed description: This is an observational, prospective, single centre study. This registry aims to evaluate long-term clinical success of EUS-guided therapeutic interventions (T-EUS), as well as adverse events, and clinical and technical variables asociated with clinical success and adverse events.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Clinical Success
timeFrame: 30 days
Secondary outcomes:
measure: Adverse events
timeFrame: 12 months
Other outcomes:
measure: Technical success
timeFrame: 1 day
measure: Recurrence
timeFrame: 12 months
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele Scientific Institute
Study officials:
affiliation: IRCCS San Raffaele Scientific Institute
name: Paolo Giorgio Arcidiacono, MD, FASGE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.