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Prospective Registry Of Therapeutic EndoscopiC ulTrasound

NCT04813055 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 510

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

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

Interventions

PROCEDURE

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

PROCEDURE

Percutaneous Procedures

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

PROCEDURE

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)

PROCEDURE

non-EUS-based endoscopic procedures

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

Sponsors & Collaborators

  • Paolo Giorgio Arcidiacono, MD

    lead OTHER

Principal Investigators

  • Paolo Giorgio Arcidiacono, MD, FASGE · IRCCS San Raffaele Scientific Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2026-12-01
Completion
2026-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04813055 on ClinicalTrials.gov