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Enrolling by Invitation

NCT Number: NCT07155616

NON-INVASIVE BLOOD FLOW ASSESSMENT: 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.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood Flow Measurement

Other

Intraoperative blood flow measurement

Primary outcomes

  1. Accuracy of blood flow modification prediction

    Time frame: 10 months

    Compare software's blood flow modification prediction with introperative measurement in each patient.

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

Computational Tool for Measuring Arterial Flow From CT

Acronym: NOVELLA

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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