Iconographic Registry of Pancreatobiliary Endoscopy Procedures

Recruiting

• Conditions: Cancer of Pancreas; Pancreas Neoplasm; Neuroendocrine Tumors; Pancreatitis

• Registration Number: NCT06344507
• Lead Sponsor: IRCCS San Raffaele

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-28
• Study First Submitted: 2024-03-21
• Study First Submitted QC: 2024-03-27
• Study First Posted: 2024-04-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-02
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Registry for images and videos	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.

Trial Locations

Locations (1)

IRCCS San Raffaele Hospital; 🇮🇹 Milan, Italy