Iconographic Registry of Pancreatobiliary Endoscopy Procedures

NCT06344507 | Recruiting

• 1 other identifier: TAILOR-EUS
• Study Type: observational
• Target: 12,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreas Neoplasm; Cancer of Pancreas; Pancreatitis; Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (1)

• Registry for images and videos

  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.

  Through study completion, an average of 5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 12,000 patients who, between 2000 and 2027, underwent endoscopic ultrasound procedures at the Bilio-Pancreatic Endoscopy and Endoscopic Ultrasound Unit of the IRCCS San Raffaele Hospital for suspected diagnoses (based on clinical and/or diagnostic evaluations suggesting a potential diagnosis of one of the diseases listed below) and/or confirmed diseases (verified by histological and/or radiological reports when histological diagnosis was not possible).

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele Hospital

Milan, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatitis; Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue

Central Study Contacts

Matteo Tacelli, MD

CONTACT

00390226435507; tacelli.matteo@hsr.it

laura apadula, MSN

CONTACT

0226433979; apadula.laura@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor UniSR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 3, 2024
• Study Start: March 28, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 2, 2025

Record last verified: 2025-04

Locations

IT (1)