The Horseshoe KidneyNCT06749782
Semi-automatic Measurement of Renal Volume at CT Angiography to Plan Repair of Aortic Aneurysms in Patients With Horseshoe Kidney.
An observational study of The Horseshoe Kidney, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- The Horseshoe Kidney
- What is being tested?
- TC
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteItaly
- Study dates
- 27 Nov 2024to 20 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
Study population: 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
Who may be able to join
- 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.
Who cannot join
- Pediatric patients (age <18 years)
- Absence of pre- and postoperative CT images
- Performance of surgery other than open surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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.
- Conditions
- The Horseshoe Kidney
- Being tested
- TC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCRadiation
Also called Radiation: Computed Tomography (CT)
Radiation: Computed Tomography (CT)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start27 Nov 2024
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for The Horseshoe KidneyStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Esposito, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749782
- Sponsor's protocol ID
- HR-AAA-CT
- Status last verified
- Sep 2024
- First submitted
- 21 Nov 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30528142Davidovic 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.
PubMed 22233614De 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.
PubMed 26730260Dorffner 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.
PubMed 9502690O'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.
PubMed 8487363Crawford 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.
PubMed 3172375O'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.
PubMed 18477115
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06749782
- Acronym / sponsor ID
- HR-AAA-CT
- Conditions
- The Horseshoe Kidney
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Pediatric patients (age <18 years)
- Absence of pre- and postoperative CT images
- Performance of surgery other than open surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCAlso: Radiation: Computed Tomography (CT)Radiation: Computed Tomography (CT) | Radiation | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Background: PubMed 30528142Wanhainen 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.
- Background: PubMed 22233614Davidovic 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.
- Background: PubMed 26730260De 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.
- Background: PubMed 9502690Dorffner 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.
- Background: PubMed 8487363O'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.
- Background: PubMed 3172375Crawford 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.
- Background: PubMed 18477115O'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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Horseshoe Kidney, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06749782, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.