Endoscopic Management of Biliopancreatic Disease in the Lombardy Pancreas Units
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age <18 years
Pregnancy or breastfeeding
Conditions other than those defined in the inclusion criteria
Inability to provide informed consent
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Diagnostic Accuracy
Number of patients with a correct diagnosis obtained through EUS-guided cyto-histological sampling, confirmed by the final diagnosis
Time frame
30 daysSecondary outcomes
1
Procedural Volume
Number of EUS procedures performed for suspected biliopancreatic neoplasms
Time frame
6 months2
Need of Repeat Sampling
Need for additional EUS-guided sampling after an initial non-diagnostic procedure
Time frame
30 days, 60 days3
Sampling Technique
Type of tissue acquisition (FNA vs FNB; ROSE vs MOSE)
Time frame
Intraprocedural4
Adverse Events
Intra- and post-procedural complications classified according to ASGE criteria
Time frame
Intraprocedural, 30 daysSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: