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Clinical Trials/NCT06344507
NCT06344507
Recruiting
Not Applicable

Iconographic Registry of Pancreatobiliary Endoscopy Procedures

IRCCS San Raffaele1 site in 1 country12,000 target enrollmentMarch 28, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pancreas Neoplasm
Sponsor
IRCCS San Raffaele
Enrollment
12000
Locations
1
Primary Endpoint
Registry for images and videos
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The aim of the TAILOR-EUS study (Iconographic Registry of Bilio-Pancreatic Endoscopic Ultrasound Procedures) is to establish a clinical registry comprising images and videos generated during endoscopic procedures conducted for the investigation of pancreatic diseases (PD). The study will compile historical, pathological, and imaging data from approximately 12,000 patients (2,000 retrospectively and 10,000 prospectively) who underwent endoscopic ultrasound procedures for inflammatory pancreatic conditions (e.g., acute, recurrent, chronic pancreatitis), autoimmune bilio-pancreatic diseases (e.g., autoimmune pancreatitis), neoplastic bilio-pancreatic conditions, and screenings for individuals at high risk of developing such diseases at the Bilio-Pancreatic Endoscopy and Endoscopic Ultrasound Unit of the IRCCS San Raffaele Hospital between 2000 and 2027.

Participants have undergone or will undergo the standard diagnostic pathway appropriate for their conditions as part of routine clinical practice. All instrumental examinations and endoscopic ultrasound procedures are integral to the standard diagnostic and therapeutic approach for pancreatic diseases.

Registry
clinicaltrials.gov
Start Date
March 28, 2022
End Date
December 31, 2027
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Paolo Giorgio Arcidiacono, MD

Associated Professor UniSR

IRCCS San Raffaele

Eligibility Criteria

Inclusion Criteria

  • Suspected or confirmed diagnosis of inflammatory pancreatic disease (e.g., acute, recurrent, or chronic pancreatitis) or autoimmune bilio-pancreatic disease (e.g., autoimmune pancreatitis) or bilio-pancreatic neoplastic disease, necessitating an endoscopic ultrasonography procedure.
  • Age over 18 years.
  • Ability to provide informed consent.

Exclusion Criteria

  • Pregnancy and breastfeeding status.
  • Contraindications to the endoscopic ultrasonography procedure

Outcomes

Primary Outcomes

Registry for images and videos

Time Frame: Through study completion, an average of 5 years

Establishment of a registry for images and videos captured during Endoscopic Ultrasonography (EUS) procedures, aimed at enhancing clinical data collection to improve patient diagnoses and advance the quality of Clinical Pathways for pancreatic diseases. The future goal of this initiative is to identify potential characteristics that could enhance the diagnostic yield of this technique and predict patient outcomes.

Study Sites (1)

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