Endoscopic Management of Biliopancreatic Disease in the Lombardy Pancreas Units
GENTLENESS
Endoscopic Management of Suspected Biliopancreatic Disease Within the Lombardy Pancreas Units: a Prospective Observational Study
1 other identifier
observational
2,500
1 country
13
Brief Summary
The GENTLENESS study is a prospective, multicenter, observational registry designed to evaluate the endoscopic management of patients with suspected biliopancreatic and periampullary neoplastic diseases within the Pancreas Units network of the Lombardy Region. Patients undergoing endoscopic ultrasound (EUS) for suspected pancreatic or periampullary malignancies, including pancreatic ductal adenocarcinoma, pancreatic neuroendocrine tumors, cystic pancreatic neoplasms requiring endoscopic, surgical, or oncological management, and periampullary tumors of the distal bile duct, ampulla, or duodenum, will be prospectively enrolled according to standard clinical practice. The study aims to assess the diagnostic accuracy of EUS-guided tissue acquisition, procedural safety, the need for repeat sampling, and organizational performance indicators, including time to definitive cyto-histological diagnosis and time to initiation of disease-specific treatment. No additional procedures beyond routine clinical care will be performed as a result of study participation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2026
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2026
CompletedFirst Posted
Study publicly available on registry
February 18, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
February 18, 2026
February 1, 2026
1 year
January 19, 2026
February 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnostic Accuracy
Number of patients with a correct diagnosis obtained through EUS-guided cyto-histological sampling, confirmed by the final diagnosis
30 days
Secondary Outcomes (6)
Procedural Volume
6 months
Need of Repeat Sampling
30 days, 60 days
Sampling Technique
Intraprocedural
Adverse Events
Intraprocedural, 30 days
Time to Diagnosis
30 days, 60 days
- +1 more secondary outcomes
Eligibility Criteria
All consecutive patients referred to participating Pancreas Unit Hub centers for EUS evaluation of suspected biliopancreatic or periampullary neoplastic disease, who meet eligibility criteria and provide informed consent.
You may qualify if:
- Adults (≥18 years)
- Clinical, biochemical, and/or imaging suspicion of pancreatic neoplasia (adenocarcinoma, neuroendocrine tumors, cystic neoplasms requiring endoscopic, surgical, or oncological treatment) or periampullary neoplasia (distal bile duct, ampulla, duodenum)
- Candidate for EUS according to standard clinical practice
- Ability to understand and sign informed consent
You may not qualify if:
- Age \<18 years
- Pregnancy or breastfeeding
- Inability to provide informed consent
- Refusal to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
ASST Papa Giovanni XXIII - P.O. Papa Giovanni XXIII Bergamo
Bergamo, Italy
ASST Spedali Civili di Brescia - P.O. Spedali Civili Brescia
Brescia, Italy
Casa di Cura Poliambulanza di Brescia
Brescia, Italy
ASST di Cremona - P.O. Cremona
Cremona, Italy
ASST Ovest Milanese - P.O. Legnano
Legnano, Italy
ASST Mantova - P.O. Carlo Poma Mantova
Mantova, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
ASST Santi Paolo e Carlo - Milano
Milan, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Milan, Italy
IRCCS Istituto Clinico Humanitas Milano
Milan, Italy
Fondazione IRCCS San Gerardo dei Tintori - Monza
Monza, Italy
Fondazione IRCCS Policlinico San Matteo Pavia
Pavia, Italy
ASST Sette Laghi - Ospedale di Circolo e Fond. Macchi Varese
Varese, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paolo Giorgio Arcidiacono, Chief
IRCCS Ospedale San Raffaele
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head - Pancreato-Biliary Endoscopy and Endosonography Division
Study Record Dates
First Submitted
January 19, 2026
First Posted
February 18, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
February 18, 2026
Record last verified: 2026-02