Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliopancreatic Diseases | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Periampullary Neoplasms | Pancreatic Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Diagnostic Accuracy
- timeFrame
- 30 days
- description
- Number of patients with a correct diagnosis obtained through EUS-guided cyto-histological sampling, confirmed by the final diagnosis
Secondary outcomes (6)
- measure
- Procedural Volume
- timeFrame
- 6 months
- description
- Number of EUS procedures performed for suspected biliopancreatic neoplasms
- measure
- Need of Repeat Sampling
- timeFrame
- 30 days, 60 days
- description
- Need for additional EUS-guided sampling after an initial non-diagnostic procedure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available