Endoscopic Management of Biliopancreatic Disease in the Lombardy Pancreas Units
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer, Biliopancreatic Diseases, Periampullary Neoplasms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Endoscopic Management of Suspected Biliopancreatic Disease Within the Lombardy Pancreas Units: a Prospective Observational Study
Overview
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.
Detailed description
Despite advances in oncological therapies, pancreatic cancer remains one of the leading causes of cancer-related mortality worldwide, with an increasing burden projected over the coming decades. The diagnostic and therapeutic pathway of biliopancreatic malignancies is complex and requires a high level of multidisciplinary expertise, particularly in high-volume referral centers organized as Pancreas Units.
Endoscopic ultrasound (EUS) plays a central role in the diagnostic work-up of biliopancreatic and periampullary lesions, allowing high-resolution morphological assessment and, when indicated, tissue acquisition through fine-needle aspiration (FNA) or fine-needle biopsy (FNB). Accurate histological diagnosis is essential for therapeutic decision-making, including surgical planning, systemic therapy, and molecular profiling.
The Lombardy Region has adopted a Hub-and-Spoke organizational model for Pancreas Units, defining minimum procedural volumes, expertise requirements, and performance benchmarks for referral centers. However, a centralized prospective system for monitoring endoscopic activity, diagnostic performance, and procedural outcomes across these centers is currently lacking.
The GENTLENESS study has been designed to prospectively collect real-world data on EUS procedures performed in Lombardy Pancreas Unit Hub centers, with the primary objective of evaluating the diagnostic accuracy of EUS-guided biopsies. Secondary objectives include assessment of procedural volume, sampling techniques, need for repeat biopsies, complication rates, and time intervals from procedure to definitive diagnosis and initiation of treatment.
The study is observational, does not introduce changes to clinical practice, and reflects routine patient management pathways. Any future analyses beyond the scope of the present registry will require separate Ethics Committee approval.
Primary outcome measures
- Diagnostic Accuracy [Time frame: 30 days]
Secondary outcome measures (6)
- Procedural Volume [Time frame: 6 months]
- Need of Repeat Sampling [Time frame: 30 days, 60 days]
- Sampling Technique [Time frame: Intraprocedural]
- Adverse Events [Time frame: Intraprocedural, 30 days]
- Time to Diagnosis [Time frame: 30 days, 60 days]
- Time to Treatment [Time frame: 30 days, 60 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 13 centers
- ASST Papa Giovanni XXIII - P.O. Papa Giovanni XXIII Bergamo — Bergamo
- ASST Spedali Civili di Brescia - P.O. Spedali Civili Brescia — Brescia
- Casa di Cura Poliambulanza di Brescia — Brescia
- ASST di Cremona - P.O. Cremona — Cremona
- ASST Ovest Milanese - P.O. Legnano — Legnano
- ASST Mantova - P.O. Carlo Poma Mantova — Mantua
- ASST Grande Ospedale Metropolitano Niguarda — Milan
- ASST Santi Paolo e Carlo - Milano — Milan
- … and 5 more centers
Identifiers
NCT: NCT07418164 · GENTLENESS