Clinical Trial Record

Return to Clinical Trials

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


2023-09-01


2026-03-30


2026-09


100

Study Overview

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.

N/A

  • Pancreatic Cancer
  • Vascular
  • Surgical Planning
  • OTHER: Blood flow measurement
  • HCB/2023/0531

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2025-08-12  

N/A  

2025-09-01  

2025-09-01  

N/A  

2025-09-04  

2025-09-04  

N/A  

2025-08  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A


Allocation:
N/A


Interventional Model:
N/A


Masking:
N/A


Arms and Interventions

Participant Group/ArmIntervention/Treatment
Primary Outcome MeasuresMeasure DescriptionTime Frame
Accuracy of blood flow modification predictionCompare software's blood flow modification prediction with introperative measurement in each patient.10 months
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available