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

H

Hospital Clinic of Barcelona

Status

Invitation-only

Conditions

Surgical Planning
Vascular
Pancreatic Cancer

Treatments

Other: Blood flow measurement

Study type

Observational

Funder types

Other

Identifiers

NCT07155616
HCB/2023/0531

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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