Prospective Registry Of Therapeutic EndoscopiC ulTrasound

Sponsor
Paolo Giorgio Arcidiacono, MD
Study ID
NCT04813055
Status
Recruiting
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Conditions

  • Acute Cholecystitis
  • Acute Pancreatic Fluid Collection
  • Acute Pancreatitis With Infected Necrosis
  • Biliary Obstruction
  • Chronic Pancreatitis
  • Gastric Outlet Obstruction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Therapeutic EUS — PROCEDURE
    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 — PROCEDURE
    Procedures involving a percutaneous access to a target region (fluid collection, gallbladder, biliary tree)
  • Surgical Interventions — PROCEDURE
    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 — PROCEDURE
    Other endoscopic procedures not involving EUS (ERCP with stenting; enteral stenting, Enteroscopy-assisted ERCP)

Study Details

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.

Key Dates

First listed
Mar 24, 2021
Start date
Dec 1, 2020
Status verified
Apr 2026
Primary completion
Dec 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
510 participants (estimated)

Arms

  • Arm: 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.
  • Arm: Controls
    Patients eligible for T-EUS procedures, but undergoing non-EUS based endoscopic procedures (e.g. ERCP or enteral stenting), surgical interventions or percutaneous interventions (e.g. Percutaneous Biliary Drainage)

Primary Outcome Measure

Clinical Success [ Time Frame: 30 days ]

Central Contacts

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