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

• Conditions: Pancreatic Cancer; Vascular; Surgical Planning

• Registration Number: NCT07155616
• Lead Sponsor: Hospital Clinic of Barcelona

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-01
• Status Verified: 2025-08
• Study First Submitted: 2025-08-12
• Study First Submitted QC: 2025-09-01
• Last Update Submitted: 2025-09-01
• Study First Posted: 2025-09-04
• Last Update Posted: 2025-09-04
• Primary Completion: 2026-03-30
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of blood flow modification prediction	10 months	Compare software's blood flow modification prediction with introperative measurement in each patient.

Trial Locations

Locations (1)

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Barcelona, Spain