Ireland
--:--IST
Enrolling by invitation Observational

NON-INVASIVE BLOOD FLOW ASSESSMENT: Computational Tool for Measuring Arterial Flow From CT

NCT07155616 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2023-09-01
Last updated
2025-09-04

Condition(s) studied

Pancreatic CancerVascularSurgical Planning

Investigational drug(s) / intervention(s)

Blood flow measurement

Blood flow measurement: Intraoperative blood flow measurement

Study 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.

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:

1. Anomalous hepatic artery anatomy in pancreaticoduodenectomy.
2. Celiac trunk stenosis.
3. Hepatic artery revascularisation from the superior mesenteric artery.
4. Hepatic artery flow assessment in liver transplantation.
5. Splenic artery flow steal phenomenon in liver transplantation.

Novella aims to develop a tool that has the capability to predict postoperative vascular flow.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Candidates for pancreaticoduodenectomy. * Good quality preoperative DICOM CT (arterial phase). * Michel's I arterial configuration. * Any surgical approach (open or robotic). * Informed consent. Exclusion Criteria: * Age \< 18 years. * Technical inability to measure flow. * GDA infiltration.

Primary outcome measure(s)

  • Accuracy of blood flow modification prediction — 10 months
    Compare software's blood flow modification prediction with introperative measurement in each patient.

Trial sites (1)

FacilityCityRegionStatus
Hospital Clínic de Barcelona Barcelona Barcelona
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07155616 on ClinicalTrials.gov ↗ ← All trials in Spain