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

NCT ID: NCT07155616

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2026-09-30

Brief Summary

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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

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Conditions

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Pancreatic Cancer Vascular Surgical Planning

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Blood flow measurement

Intraoperative blood flow measurement

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Clínic de Barcelona

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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HCB/2023/0531

Identifier Type: -

Identifier Source: org_study_id

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