Pancreatic CancerNOVELLANCT07155616
NON-INVASIVE BLOOD FLOW ASSESSMENT: Computational Tool for Measuring Arterial Flow From CT
An observational study of Pancreatic Cancer and Vascular, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Major invasive surgery, such as oncological abdominal surgery, is associated with a high risk of complications and mortality. One of the main problems in this type of surgery is the difficulty in preserving the arteries and veins necessary to support vital organs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Vascular, Surgical Planning
- What is being tested?
- Blood flow measurement
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2023to Sep 2026
- 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
- Adult, Older adult
Study population: Patients undergoing pancreaticoduodenectomy for any reason.
Who may be able to join
- Candidates for pancreaticoduodenectomy.
- Good quality preoperative DICOM CT (arterial phase).
- Michel's I arterial configuration.
- Any surgical approach (open or robotic).
- Informed consent.
Who cannot join
- Age < 18 years.
- Technical inability to measure flow.
- GDA infiltration.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Computational Tool for Measuring Arterial Flow From CT
Major invasive surgery, such as oncological abdominal surgery, is associated with a high risk of complications and mortality.
One of the main problems in this type of surgery is the difficulty in preserving the arteries and veins necessary to support vital organs.
Read more
The main objective of this project is to develop software to predict vascular flow changes based on preoperative computed tomography (CT) scans.
Currently, the only way to assess preoperative vascular flow is through percutaneous angiography. This is an invasive procedure that requires anaesthesia, hospitalisation, high doses of radiation, vessel manipulation and the possibility of serious injury. It is often used for the diagnosis of vascular stenosis, analysis of vascular flow and preoperative planning to determine which vessels are directly related to organ perfusion.
This preoperative planning will be key in the following clinical scenarios:
- Anomalous hepatic artery anatomy in pancreaticoduodenectomy.
- Celiac trunk stenosis.
- Hepatic artery revascularisation from the superior mesenteric artery.
- Hepatic artery flow assessment in liver transplantation.
- Splenic artery flow steal phenomenon in liver transplantation.
Novella aims to develop a tool that has the capability to predict postoperative vascular flow.
- Conditions
- Pancreatic Cancer, Vascular, Surgical Planning
- Being tested
- Blood flow measurement
- Keywords
- surgical planning, pancreatic surgery
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow measurementOther
Intraoperative blood flow measurement
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of blood flow modification prediction
Compare software's blood flow modification prediction with introperative measurement in each patient.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Sep 2023
- Primary completion30 Mar 2026 (estimated)
- Study completionSep 2026 (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 Hospital Clinic of BarcelonaThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155616
- Sponsor's protocol ID
- HCB/2023/0531
- Acronym
- NOVELLA
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computational Tool for Measuring Arterial Flow From CT
- ClinicalTrials.gov ID
- NCT07155616
- Acronym / sponsor ID
- NOVELLA / HCB/2023/0531
- Conditions
- Pancreatic Cancer, Vascular, Surgical Planning
- Keywords
- surgical planning, pancreatic surgery
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 4 Sep 2025 (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.
Major invasive surgery, such as oncological abdominal surgery, is associated with a high risk of complications and mortality.
One of the main problems in this type of surgery is the difficulty in preserving the arteries and veins necessary to support vital organs.
The main objective of this project is to develop software to predict vascular flow changes based on preoperative computed tomography (CT) scans.
Currently, the only way to assess preoperative vascular flow is through percutaneous angiography. This is an invasive procedure that requires anaesthesia, hospitalisation, high doses of radiation, vessel manipulation and the possibility of serious injury. It is often used for the diagnosis of vascular stenosis, analysis of vascular flow and preoperative planning to determine which vessels are directly related to organ perfusion.
This preoperative planning will be key in the following clinical scenarios:
- Anomalous hepatic artery anatomy in pancreaticoduodenectomy.
- Celiac trunk stenosis.
- Hepatic artery revascularisation from the superior mesenteric artery.
- Hepatic artery flow assessment in liver transplantation.
- Splenic artery flow steal phenomenon in liver transplantation.
Novella aims to develop a tool that has the capability to predict postoperative vascular flow.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing pancreaticoduodenectomy for any reason.
Key inclusion criteria (5 listed)
- Candidates for pancreaticoduodenectomy.
- Good quality preoperative DICOM CT (arterial phase).
- Michel's I arterial configuration.
- Any surgical approach (open or robotic).
- Informed consent.
Key exclusion criteria (3 listed)
- Age < 18 years.
- Technical inability to measure flow.
- GDA infiltration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood flow measurementIntraoperative blood flow measurement | Other | – |
Primary outcome
Accuracy of blood flow modification prediction
Time frame: 10 months
Compare software's blood flow modification prediction with introperative measurement in each patient.
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 4 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pancreatic Cancer and Vascular, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 3 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: enrolling by invitation, as of the sponsor's last update on 4 Sep 2025. 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 Spain. 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?
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?
Accuracy of blood flow modification prediction (time frame: 10 months). 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 4 Sep 2025.