Pancreatic CancerGENTLENESSNCT07418164
Endoscopic Management of Biliopancreatic Disease in the Lombardy Pancreas Units
An observational study of Pancreatic Cancer and Biliopancreatic Diseases, run by IRCCS San Raffaele at 13 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Biliopancreatic Diseases, Periampullary Neoplasms
- How many people
- 2,500 participants
- Where
- 13 sitesItaly
- Study dates
- 31 Oct 2026to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
Italy13 sites
ASST Papa Giovanni XXIII - P.O. Papa Giovanni XXIII Bergamo
Bergamo
Salvatore Greco
ASST Spedali Civili di Brescia - P.O. Spedali Civili Brescia
Brescia
Gianpaolo Cengia
Casa di Cura Poliambulanza di Brescia
Brescia
Paolo Cesaro
ASST di Cremona - P.O. Cremona
Cremona
Roberto Grassia
ASST Ovest Milanese - P.O. Legnano
Legnano
Pietro Giambitta
ASST Mantova - P.O. Carlo Poma Mantova
Mantua
Nicola Mantovani
ASST Grande Ospedale Metropolitano Niguarda
Milan
Massimiliano Mutignani
ASST Santi Paolo e Carlo - Milano
Milan
Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Milan
Paolo Cantù
IRCCS Istituto Clinico Humanitas Milano
Milan
Alessandro Repici
Fondazione IRCCS San Gerardo dei Tintori - Monza
Monza
Marco Dinelli
Fondazione IRCCS Policlinico San Matteo Pavia
Pavia
Andrea Anderloni
ASST Sette Laghi - Ospedale di Circolo e Fond. Macchi Varese
Varese
Sergio Segato
About this study
Official title: Endoscopic Management of Suspected Biliopancreatic Disease Within the Lombardy Pancreas Units: a Prospective Observational Study
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.
Read the 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.
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy
Number of patients with a correct diagnosis obtained through EUS-guided cyto-histological sampling, confirmed by the final diagnosis
Measured: 30 days
Secondary outcomes (6)
Procedural Volume
Number of EUS procedures performed for suspected biliopancreatic neoplasms
Measured: 6 months
Need of Repeat Sampling
Need for additional EUS-guided sampling after an initial non-diagnostic procedure
Measured: 30 days, 60 days
Sampling Technique
Type of tissue acquisition (FNA vs FNB; ROSE vs MOSE)
Measured: Intraprocedural
Adverse Events
Intra- and post-procedural complications classified according to ASGE criteria
Measured: Intraprocedural, 30 days
Time to Diagnosis
Time from EUS to availability of definitive cyto-histological report
Measured: 30 days, 60 days
Time to Treatment
Time from diagnosis to initiation of disease-specific treatment
Measured: 30 days, 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start31 Oct 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Giorgio Arcidiacono, MD, IRCCS San Raffaele
- Investigators
- Paolo Giorgio Arcidiacono, Chief, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418164
- Sponsor's protocol ID
- GENTLENESS
- Acronym
- GENTLENESS
- Status last verified
- Sep 2026
- First submitted
- 19 Jan 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Management of Suspected Biliopancreatic Disease Within the Lombardy Pancreas Units: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07418164
- Acronym / sponsor ID
- GENTLENESS / GENTLENESS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Accuracy
Time frame: 30 days
Number of patients with a correct diagnosis obtained through EUS-guided cyto-histological sampling, confirmed by the final diagnosis
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paolo Giorgio Arcidiacono, Chief principal investigator
IRCCS Ospedale San Raffaele
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Biliopancreatic Diseases, run by IRCCS San Raffaele at 13 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gaetano Lauri, PhDs (0226436303, lauri.gaetano@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.