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Enrolling by invitation NCT07155616

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

Observational Pancreatic Cancer Vascular Surgical Planning

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood flow measurement.
Who it may be relevant to
Registry conditions: Pancreatic Cancer, Vascular, Surgical Planning. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Computational Tool for Measuring Arterial Flow From CT

Overview

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

  • Other Blood flow measurement
    Intraoperative blood flow measurement

Primary outcome measures

  • Accuracy of blood flow modification prediction [Time frame: 10 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Spain · 1 center
  • Hospital Clínic de Barcelona — Barcelona

Identifiers

NCT: NCT07155616 · HCB/2023/0531

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗