Hilar CholangiocarcinomaNCT07621536
Diagnostic Accuracy of Eus Fnb in Difficult to Reach Lesions
An observational study of Hilar Cholangiocarcinoma and Duodenal Neoplasms, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The present study aims at comprehensively assessing the diagnostic performance and safety profile of EUS-FNB as a primary diagnostic tool for suspected malignancies in anatomically complex or deeply situated regions, including the duodeno-jejunal, and hepatic hilar areas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hilar Cholangiocarcinoma, Duodenal Neoplasms
- How many people
- 131 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2025to 1 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Data on all the consecutive EUS performed for para-duodenal, para-jejunal land hepatic hilum lesions in our Unit between January 2013 and June 2023 will be retrospectively reviewed. Telephone contact will be performed if additional information is required to fulfil the Case Report Forms (CRF). CRFs will be used to collect the data. CRFs are fully anonymized using a progressive alphanumeric identification code and the age instead of the date of birth. CRFs will be translated into an electronic spreadsheet.
Who may be able to join
- age ≥ 18 years;
- patients with one or multiple lesions adjacent to the distal duodenum, or the proximal jejunum, or the hepatic hilum that underwent EUS in our Institution over the past 10 years;
- Patients monitored for at least 6 months after EUS-FNB or until death (follow-up less than 6 months);
- Available data;
- Written informed consent.
Who cannot join
- Age less than 18 years old;
- Patient unable to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario A Gemelli IRCCS
Rome, RM, 00168
About this study
Official title: Diagnostic Accuracy of Endoscopic Ultrasound-guided Fine Needle Biopsy in Assessing "Difficult-to-reach" Abdominal Lesions: an Observational, Retrospective Cohort Study
The present study aims at comprehensively assessing the diagnostic performance and safety profile of EUS-FNB as a primary diagnostic tool for suspected malignancies in anatomically complex or deeply situated regions, including the duodeno-jejunal, and hepatic hilar areas. By focusing on lesions that are challenging to reach due to their intricate anatomy or profound depth, investigators seek to provide valuable insights into the potential role of EUS-FNB in enhancing diagnostic accuracy and safety in these complex clinical scenarios.
- Conditions
- Hilar Cholangiocarcinoma, Duodenal Neoplasms
- Medical subject headings
- Klatskin Tumor, Duodenal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of eus fnb
Diagnostic accuracy, calculated according to the formula = (true positives + true negatives) / (true positives + false positives + true negatives + false negatives), of EUS-FNB for all the difficult-to-detect abdominal lesions.
Measured: At 6 months after EUS-FNB, or at the time of surgical histopathologic diagnosis if surgery occurred earlier
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Oct 2025
- Primary completion1 Jan 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hilar CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Retrospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Spada Cristiano, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Cristiano Spada, Professor, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621536
- Sponsor's protocol ID
- 7859
- Status last verified
- Jun 2026
- First submitted
- 25 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Endoscopic Ultrasound-guided Fine Needle Biopsy in Assessing "Difficult-to-reach" Abdominal Lesions: an Observational, Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07621536
- Acronym / sponsor ID
- 7859
- Conditions
- Hilar Cholangiocarcinoma, Duodenal Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 2 Jun 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 present study aims at comprehensively assessing the diagnostic performance and safety profile of EUS-FNB as a primary diagnostic tool for suspected malignancies in anatomically complex or deeply situated regions, including the duodeno-jejunal, and hepatic hilar areas. By focusing on lesions that are challenging to reach due to their intricate anatomy or profound depth, investigators seek to provide valuable insights into the potential role of EUS-FNB in enhancing diagnostic accuracy and safety in these complex clinical scenarios.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data on all the consecutive EUS performed for para-duodenal, para-jejunal land hepatic hilum lesions in our Unit between January 2013 and June 2023 will be retrospectively reviewed. Telephone contact will be performed if additional information is required to fulfil the Case Report Forms (CRF). CRFs will be used to collect the data. CRFs are fully anonymized using a progressive alphanumeric identification code and the age instead of the date of birth. CRFs will be translated into an electronic spreadsheet.
Key inclusion criteria (5 listed)
- age ≥ 18 years;
- patients with one or multiple lesions adjacent to the distal duodenum, or the proximal jejunum, or the hepatic hilum that underwent EUS in our Institution over the past 10 years;
- Patients monitored for at least 6 months after EUS-FNB or until death (follow-up less than 6 months);
- Available data;
- Written informed consent.
Key exclusion criteria (2 listed)
- Age less than 18 years old;
- Patient unable to sign the informed consent.
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 of eus fnb
Time frame: At 6 months after EUS-FNB, or at the time of surgical histopathologic diagnosis if surgery occurred earlier
Diagnostic accuracy, calculated according to the formula = (true positives + true negatives) / (true positives + false positives + true negatives + false negatives), of EUS-FNB for all the difficult-to-detect abdominal lesions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Hilar Cholangiocarcinoma
Active, not recruitingPhase 2
Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial)
Advanced Biliary Tract Carcinoma, Advanced Gallbladder Carcinoma
Active, not recruitingPhase 3
Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)
Biliary Tract Cancer
Recruiting
Liver Transplantation for Non-resectable Perihilar Cholangiocarcinoma
Perihilar Cholangiocarcinoma, Klatskin Tumor
RecruitingPhase 2
Phase II Study of Neoadjuvant Tislelizumab Plus Radiotherapy and GP Chemotherapy for Borderline/Unresectable Hilar Cholangiocarcinoma
Cholangiocarcinoma, Hilar Cholangiocarcinoma
Recruiting
Suprapapillary Metal Stent vs. Routine Transpapillary Drainage in Malignant Hilar Biliary Obstruction (SMART-B Trial)
Cholangiocarcinoma, Bile Duct Neoplasms
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. This study is not recruiting at the moment.
Cristiano Spada, Professor principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hilar Cholangiocarcinoma and Duodenal Neoplasms, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of eus fnb (time frame: At 6 months after EUS-FNB, or at the time of surgical histopathologic diagnosis if surgery occurred earlier). 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 2 Jun 2026.