NCT07418164Not yet recruiting
Endoscopic Management of Biliopancreatic Disease in the Lombardy Pancreas Units
Endoscopic Management of Suspected Biliopancreatic Disease Within the Lombardy Pancreas Units: a Prospective Observational Study
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 2500 (estimated)
- First submitted
- 19 Jan 2026
- Start date
- 31 Oct 2026
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Pancreatic cancer
- NCT number
- NCT07418164
What you commit to
- Study type: Observational
- Planned participants: 2500
- From 31 Oct 2026 to the primary completion date, 30 Apr 2027
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Conditions other than those defined in the inclusion criteria
Age
- Age \<18 years
Other
- Pregnancy or breastfeeding
- Inability to provide informed consent
- Refusal to participate in the study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ASST Papa Giovanni XXIII - P.O. Papa Giovanni XXIII Bergamo Coordinator of this site? Confirm its status | Bergamo | Italy | Unknown status |
| Casa di Cura Poliambulanza di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Unknown status |
| ASST Spedali Civili di Brescia - P.O. Spedali Civili Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Unknown status |
| ASST di Cremona - P.O. Cremona Coordinator of this site? Confirm its status | Cremona | Italy | Unknown status |
| ASST Ovest Milanese - P.O. Legnano Coordinator of this site? Confirm its status | Legnano | Italy | Unknown status |
| ASST Mantova - P.O. Carlo Poma Mantova Coordinator of this site? Confirm its status | Mantua | Italy | Unknown status |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| ASST Santi Paolo e Carlo - Milano Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Fondazione IRCCS - Istituto Nazionale dei Tumori - Milano Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| IRCCS Istituto Clinico Humanitas Milano Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Fondazione IRCCS San Gerardo dei Tintori - Monza Coordinator of this site? Confirm its status | Monza | Italy | Unknown status |
| Fondazione IRCCS Policlinico San Matteo Pavia Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
| ASST Sette Laghi - Ospedale di Circolo e Fond. Macchi Varese Coordinator of this site? Confirm its status | Varese | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.