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OpenTrials
Completed

NCT Number: NCT06749782

Semi-automatic Measurement of Renal Volume at CT Angiography to Plan Repair of Aortic Aneurysms in Patients With Horseshoe Kidney.

The horseshoe kidney (HK) is a congenital anomaly in which the kidneys are fused in front of the anterior aortic wall in its most common form. The association of abdominal aortic aneurysm (AAA) and horseshoe kidney (HK) is a rare and challenging condition, occurring in less than 0.2% of all AAA cases. In these cases, open surgery is still widely practiced in many centers, with either a transperitoneal or retroperitoneal approach. Typically, several polar arteries arise from the distal abdominal aorta or the iliac arteries to perfuse the HK.

A key consideration for the surgery is whether or not to preserve the vascularization of the variant kidney. Preserving them can be challenging, but removing them can lead to a significant reduction in renal volume and subsequent loss of function. In open surgery repair, it is recommended to reanastomose as many arteries as possible to the prosthesis, even though this introduces additional technical challenges, especially in emergency situations. Computed Tomography Angiography (CTA) is the best diagnostic test for performing a preoperative vascular assessment.

The purpose of the present study is to develop a semi-automated model on preoperative CCTA to measure the volume of parenchyma perfused by each artery to determine whether or not these should be preserved. The model will be validated on post-surgical CCTA in patients with HK treated for AAA.

Customized use of this tool could be a valuable method in surgical decision making, determining which arteries can be made safe during surgery and addressing a rare but complex clinical need.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale San Raffaele

Milan, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult subjects (≥18 years old) surgically treated for AAA with HK at San Raffaele Hospital between January 2019 and December 2023, with appropriate pre- and postoperative CTA, pre- and post CT.

Exclusion criteria

  • Pediatric patients (age <18 years)
  • Absence of pre- and postoperative CT images
  • Performance of surgery other than open surgery.

Treatment and study plan

TC

Radiation

Radiation: Computed Tomography (CT)

Other names: Radiation: Computed Tomography (CT)

Primary outcomes

  1. A semi-automatic model to measure renal volume downstream of each HK artery on presurgical CTA.tomographic angiography validated on surgery.

    Time frame: through study completion, an average of 1 month

    Measurement of renal volume perfused by each artery at preoperative computed tomographic angiography validated on surgery.

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

Semi-automatic Measurement of Renal Volume at Computed Tomography (CT) Angiography to Plan Repair of Aortic Aneurysms in Patients With Horseshoe Kidney: a Retrospective Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 27, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.