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

Computational Tool for Measuring Arterial Flow From CT

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07155616
Acronym
NOVELLA
Enrollment
100
Registered
2025-09-04
Start date
2023-09-01
Completion date
2026-09-30
Last updated
2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer, Vascular, Surgical Planning

Keywords

surgical planning, pancreatic surgery

Brief 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.

Interventions

Intraoperative blood flow measurement

Sponsors

Hospital Clinic of Barcelona
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of blood flow modification prediction10 monthsCompare software's blood flow modification prediction with introperative measurement in each patient.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026