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Clinical Trials in Italy / NCT07418164
Starting soon Observational

Endoscopic Management of Biliopancreatic Disease in the Lombardy Pancreas Units

NCT07418164 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS San Raffaele
Phase
Observational
Started
2026-10-31
Last updated
2026-09-03

Condition(s) studied

Pancreatic CancerBiliopancreatic DiseasesPeriampullary Neoplasms

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * Age \<18 years * Pregnancy or breastfeeding * Conditions other than those defined in the inclusion criteria * Inability to provide informed consent * Refusal to participate in the study

Primary outcome measure(s)

Trial sites (13)

FacilityCityRegionStatus
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 Mantua 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

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Other trials for the same condition

Alpha Radiation Emitters for the Treatment of Pancreatic Cancer for the Treatment of Locally Advanced Pancreatic Cancer Recruiting
A Study of Zolbetuximab (IMAB362) in Adults With Pancreatic Cancer Active, not recruiting
Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) Active, not recruiting
Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies Active, not recruiting
Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07418164 on ClinicalTrials.gov ↗ ← All trials in Italy