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

NCT07155616 | Enrolling By Invitation

• 1 other identifier: HCB/2023/0531
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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. 1.Anomalous hepatic artery anatomy in pancreaticoduodenectomy.
2. 2.Celiac trunk stenosis.
3. 3.Hepatic artery revascularisation from the superior mesenteric artery.
4. 4.Hepatic artery flow assessment in liver transplantation.
5. 5.Splenic artery flow steal phenomenon in liver transplantation.

Conditions

Pancreatic Cancer; Vascular; Surgical Planning

Keywords

surgical planning; pancreatic surgery

Outcome Measures

Primary Outcomes (1)

• Accuracy of blood flow modification prediction

  Compare software's blood flow modification prediction with introperative measurement in each patient.

  10 months

Interventions

Blood flow measurement OTHER

Intraoperative blood flow measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing pancreaticoduodenectomy for any reason.

You may qualify if:

• Candidates for pancreaticoduodenectomy.
• Good quality preoperative DICOM CT (arterial phase).
• Michel's I arterial configuration.
• Any surgical approach (open or robotic).
• Informed consent.

You may not qualify if:

• Age \< 18 years.
• Technical inability to measure flow.
• GDA infiltration.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: September 4, 2025
• Study Start: September 1, 2023
• Primary Completion: March 30, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

ES (1)