Semi-automatic Measurement of Renal Volume at CT Angiography to Plan Repair of Aortic Aneurysms in Patients With Horseshoe Kidney.
1 other identifier
observational
5
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2024
CompletedStudy Start
First participant enrolled
November 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2024
CompletedFirst Posted
Study publicly available on registry
December 27, 2024
CompletedDecember 27, 2024
September 1, 2024
23 days
November 21, 2024
December 23, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
A semi-automatic model to measure renal volume downstream of each HK artery on presurgical CTA.tomographic angiography validated on surgery.
Measurement of renal volume perfused by each artery at preoperative computed tomographic angiography validated on surgery.
through study completion, an average of 1 month
Interventions
Eligibility Criteria
All consecutive patients surgically treated for AAA with HK at San Raffaele Hospital between January 2019 and December 2023, with appropriate pre- and post-operative CTA
You may qualify if:
- 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.
You may not qualify if:
- Pediatric patients (age \<18 years)
- Absence of pre- and postoperative CT images
- Performance of surgery other than open surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Ospedale San Raffaele
Milan, Italy
Related Publications (7)
Wanhainen A, Verzini F, Van Herzeele I, Allaire E, Bown M, Cohnert T, Dick F, van Herwaarden J, Karkos C, Koelemay M, Kolbel T, Loftus I, Mani K, Melissano G, Powell J, Szeberin Z, Esvs Guidelines Committee, de Borst GJ, Chakfe N, Debus S, Hinchliffe R, Kakkos S, Koncar I, Kolh P, Lindholt JS, de Vega M, Vermassen F, Document Reviewers, Bjorck M, Cheng S, Dalman R, Davidovic L, Donas K, Earnshaw J, Eckstein HH, Golledge J, Haulon S, Mastracci T, Naylor R, Ricco JB, Verhagen H. Editor's Choice - European Society for Vascular Surgery (ESVS) 2019 Clinical Practice Guidelines on the Management of Abdominal Aorto-iliac Artery Aneurysms. Eur J Vasc Endovasc Surg. 2019 Jan;57(1):8-93. doi: 10.1016/j.ejvs.2018.09.020. Epub 2018 Dec 5. No abstract available.
PMID: 30528142BACKGROUNDDavidovic L, Markovic M, Ilic N, Koncar I, Kostic D, Simic D, Tomic I. Repair of abdominal aortic aneurysms in the presence of the horseshoe kidney. Int Angiol. 2011 Dec;30(6):534-40.
PMID: 22233614BACKGROUNDDe Caridi G, Massara M, Greco M, Mastrojeni C, Serra R, Salomone I, La Spada M. Surgical Treatment of a Voluminous Infrarenal Abdominal Aortic Aneurysm with Horseshoe Kidney: Tips and Tricks. Ann Vasc Dis. 2015;8(4):324-7. doi: 10.3400/avd.cr.15-00083. Epub 2015 Oct 20.
PMID: 26730260BACKGROUNDDorffner R, Thurnher S, Prokesch R, Youssefzadeh S, Holzenbein T, Lammer J. Spiral CT during selective accessory renal artery angiography: assessment of vascular territory before aortic stent-grafting. Cardiovasc Intervent Radiol. 1998 Mar-Apr;21(2):179-82. doi: 10.1007/s002709900239.
PMID: 9502690BACKGROUNDO'Hara PJ, Hakaim AG, Hertzer NR, Krajewski LP, Cox GS, Beven EG. Surgical management of aortic aneurysm and coexistent horseshoe kidney: review of a 31-year experience. J Vasc Surg. 1993 May;17(5):940-7.
PMID: 8487363BACKGROUNDCrawford ES, Coselli JS, Safi HJ, Martin TD, Pool JL. The impact of renal fusion and ectopia on aortic surgery. J Vasc Surg. 1988 Oct;8(4):375-83. doi: 10.1067/mva.1988.avs0080375.
PMID: 3172375BACKGROUNDO'Brien J, Buckley O, Doody O, Ward E, Persaud T, Torreggiani W. Imaging of horseshoe kidneys and their complications. J Med Imaging Radiat Oncol. 2008 Jun;52(3):216-26. doi: 10.1111/j.1440-1673.2008.01950.x.
PMID: 18477115BACKGROUND
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 21, 2024
First Posted
December 27, 2024
Study Start
November 27, 2024
Primary Completion
December 20, 2024
Study Completion
December 20, 2024
Last Updated
December 27, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share