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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
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

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
ASST Papa Giovanni XXIII - P.O. Papa Giovanni XXIII Bergamo
Coordinator of this site? Confirm its status
BergamoItalyUnknown status
Casa di Cura Poliambulanza di Brescia
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BresciaItalyUnknown status
ASST Spedali Civili di Brescia - P.O. Spedali Civili Brescia
Coordinator of this site? Confirm its status
BresciaItalyUnknown status
ASST di Cremona - P.O. Cremona
Coordinator of this site? Confirm its status
CremonaItalyUnknown status
ASST Ovest Milanese - P.O. Legnano
Coordinator of this site? Confirm its status
LegnanoItalyUnknown status
ASST Mantova - P.O. Carlo Poma Mantova
Coordinator of this site? Confirm its status
MantuaItalyUnknown status
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyUnknown status
ASST Santi Paolo e Carlo - Milano
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MilanItalyUnknown status
Fondazione IRCCS - Istituto Nazionale dei Tumori - Milano
Coordinator of this site? Confirm its status
MilanItalyUnknown status
IRCCS Istituto Clinico Humanitas Milano
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MilanItalyUnknown status
Fondazione IRCCS San Gerardo dei Tintori - Monza
Coordinator of this site? Confirm its status
MonzaItalyUnknown status
Fondazione IRCCS Policlinico San Matteo Pavia
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PaviaItalyUnknown status
ASST Sette Laghi - Ospedale di Circolo e Fond. Macchi Varese
Coordinator of this site? Confirm its status
VareseItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.