Registry analyzing outcomes of therapeutic endoscopic ultrasound procedures
Prospective Registry Of Therapeutic EndoscopiC ulTrasound
IRCCS San Raffaele · NCT04813055
This study looks at how well therapeutic endoscopic ultrasound works for people with gastrointestinal issues and what factors might affect the results.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 510 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele (other) |
| Locations | 1 site (Milan) |
| Trial ID | NCT04813055 on ClinicalTrials.gov |
What this trial studies
This observational registry evaluates the long-term outcomes of therapeutic endoscopic ultrasound (T-EUS) procedures for various gastrointestinal conditions. It aims to identify clinical and technical variables that may predict success or adverse events associated with these interventions. Patients eligible for T-EUS will be enrolled, and those undergoing alternative procedures will serve as controls. The study will collect data on clinical success rates and complications to improve candidate selection for T-EUS.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are eligible for therapeutic endoscopic ultrasound procedures for conditions like gastric outlet obstruction or biliary obstruction.
Not a fit: Patients under 18 years old or those with contraindications for endoscopy may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could enhance the selection process for patients undergoing therapeutic endoscopic ultrasound, potentially leading to improved outcomes.
How similar studies have performed: Other studies have shown promising results with therapeutic endoscopic ultrasound, indicating that this approach is both relevant and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * subjects candidate to therapeutic EUS (T-EUS) procedures for any underlying disease * subject eligible to T-EUS procedures but undergoing other non-EUS based endoscopic procedures, percutaneous or surgical procedures * 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
Where this trial is running
Milan
- IRCCS San Raffaele Scientific Institute — Milan, Italy (RECRUITING)
Study contacts
- Principal investigator: Paolo Giorgio Arcidiacono, MD, FASGE — IRCCS San Raffaele Scientific Institute
- Study coordinator: Giuseppe Vanella, MD
- Email: vanella.giuseppe@hsr.it
- Phone: +390226439574
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastric Outlet Obstruction, Biliary Obstruction, Acute Pancreatic Fluid Collection, Acute Pancreatitis With Infected Necrosis, Acute Cholecystitis, Chronic Pancreatitis, Endoscopic ultrasound, Therapeutic EUS