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RecruitingNCT04813055

Prospective Registry Of Therapeutic EndoscopiC ulTrasound

Sponsor

Paolo Giorgio Arcidiacono, MD

Enrollment

510 participants

Start Date

Dec 1, 2020

Study Type

OBSERVATIONAL

Conditions

Chronic PancreatitisGastric Outlet ObstructionAcute Pancreatic Fluid CollectionAcute CholecystitisAcute Pancreatitis With Infected NecrosisBiliary Obstruction

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. The study also includes standard alternatives to T-EUS procedures for outcomes comparison.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is a registry — a large organized collection of data — for people who undergo a specialized type of endoscopy called therapeutic endoscopic ultrasound (T-EUS). This procedure uses a thin flexible tube with an ultrasound probe to both look inside the digestive tract and treat certain conditions, such as draining fluid collections, treating blockages, or taking biopsies. The goal is to track outcomes for patients who receive this procedure so that doctors can learn more about how well it works and how safe it is across many different diseases and patients. There is no experimental treatment — this is an observation study only. You may be eligible if: - You are 18 years of age or older - You are scheduled for or have had a therapeutic EUS procedure for any underlying condition - You are willing and able to sign an informed consent form You may NOT be eligible if: - You are under 18 years old - You are unable or unwilling to sign the consent form - You have a medical reason why you cannot have an endoscopy or fluoroscopy (X-ray guidance) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 (ERCP with stenting; enteral stenting, Enteroscopy-assisted ERCP)

Locations(1)

IRCCS San Raffaele Scientific Institute

Milan, Italy

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NCT04813055

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