Registry Study of Therapeutic Endoscopic Ultrasound Procedures
and Comparison With Alternative Treatments
Led by Paolo Giorgio Arcidiacono, MD · Updated on 2026-04-13
510
Participants Needed
1
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term outcomes of therapeutic endoscopic ultrasound T-EUS procedures used to treat conditions like gastric outlet obstruction, biliary obstruction, acute pancreatic fluid collections, infected necrosis, acute cholecystitis, and chronic pancreatitis. This observational, prospective study aims to understand clinical success rates and adverse events, as well as the clinical and technical factors that may predict these results. The study also includes patients undergoing alternative standard procedures for comparison.
The treatments studied include various T-EUS procedures such as EUS-guided drainage of collections, biliary drainage, gallbladder drainage, gastro-jejunostomy, EUS-directed ERCP, and pancreatic duct drainage using plastic or metal stents. Patients receiving these procedures will be compared to control patients undergoing non-EUS endoscopic, percutaneous, or surgical interventions for similar clinical indications.
Participants will be followed to collect data on clinical success at 30 days and adverse events up to 12 months. Researchers will review clinical and technical variables associated with outcomes. The study involves standard clinical practice decisions, with data collected from both T-EUS and control procedure groups to better understand which patients benefit most from these interventions and how to predict risks. Participation includes informed consent and regular follow-up visits or assessments as dictated by clinical care.
CONDITIONS
Brief Title
Prospective Registry Of Therapeutic EndoscopiC ulTrasound
Research Team
G
Giuseppe Vanella, MD
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Candidates for therapeutic endoscopic ultrasound (T-EUS) procedures for any underlying disease
Eligible for T-EUS procedures but undergoing other non-EUS endoscopic, percutaneous, or surgical procedures
18 years old or older
Able to provide informed consent
You will not qualify if you...
Younger than 18 years
Unable or unwilling to sign informed consent
Contraindication for endoscopy or use of fluoroscopy
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 1 week
Participants undergo evaluation to determine the most appropriate therapeutic or alternative procedures based on standard clinical practice.
1 visit (in-person)
Implementation
Duration - Single procedure visit with possible additional interventions as clinically indicated
Participants receive therapeutic endoscopic ultrasound procedures or alternative interventions such as non-EUS endoscopic, percutaneous, or surgical procedures according to their assigned group.
1 procedure visit (in-person)
Long-term Monitoring
Duration - Up to 12 months
Participants are followed to evaluate clinical success, adverse events, and other clinical outcomes over time.
Follow-up visits as scheduled for up to 12 months
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
EUS-guided drainage of Post-Surgical versus Post-Pancreatitis collections (the RESPELL study): A prospective comparison of clinical presentations and therapeutic outcomes.
Giuseppe Vanella, Francesco Frigo, Roberto Leone...
Endoscopic ultrasound-guided choledochoduodenostomy versus hepaticogastrostomy combined with gastroenterostomy in malignant double obstruction (CABRIOLET_Pro): A prospective comparative study.
Giuseppe Vanella, Roberto Leone, Francesco Frigo...
Long-term outcomes of endoscopic ultrasound-guided gastroenterostomy: a prospective cohort study tracking symptom recurrence, reintervention timelines, and stent modifications over time.
Giuseppe Vanella, Francesco Frigo, Francesca Perelli...