Iconographic Registry of Pancreatobiliary Endoscopy Procedures

Neuroendocrine Tumors Clinical Trial

— TAILOR-EUS  

Official title:

Iconographic Registry of Pancreatobiliary Endoscopy Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06344507
• Other study ID #: TAILOR-EUS
• Status: Recruiting
• Start date: March 28, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: IRCCS San Raffaele
• Contact: Matteo Tacelli, MD
• Phone: 00390226435507
• Email: tacelli.matteo[@]hsr.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12000
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Pancreas
• Neuroendocrine Tumors
• Pancreas Neoplasm
• Pancreatic Neoplasms
• Pancreatitis

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele Hospital	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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