RETRO Study (RETrograde Renal Access Outcomes)

Официальное название

RetroPerc®-A Prospective, Multi-institutional Trial of Efficacy of the RetroPerc Device

Обзор

The goal of this observational study is to learn about the benefit of using RetroPerc® in obtaining renal access for percutaneous nephrolithotomy. The device is already used in routine clinical practice by urologists around the country. Participants who are already scheduled to undergo percutaneous nephrolithotomy as part of their regular care will be asked to participate.

Подробное описание

Retrograde nephrostomy access is well established as a safe method for nephrostomy creation and thus this study aims to perform a standard of care study. The device is already available, on the shelf, and used in routine clinical care. However, the study aims to take a closer look in a prospective fashion at this access technique to better understand specific variables that are not available on retrospective review of cases that have already undergone PCNL with this technique.

Вмешательства

• Устройство RetroPerc®
  The RetroPerc® will be used to obtain renal access.

Первичные конечные точки

• Proportion of successful renal access per access attempts [Срок оценки: Procedure]

Вторичные конечные точки (4)

• Location of Renal Access [Срок оценки: Procedure]
• Time to gain renal access [Срок оценки: Procedure]
• Total Procedure Time [Срок оценки: Procedure]
• Length of Post-Operative Hospital Stay [Срок оценки: Day 0 to 3 Months Post-Operative]

Критерии участия

Критерии включения

• Renal stone or total linear sum of 1.5-3cm cm in maximum dimension (largest diameter in axial or coronal)--- multiple stones should be summed to determine stone size.
• Age >=18 years of age
• Gender: both men and women included.
• Ethnic background: all ethnicities will be included in the study population and the specific ethnic diversity present in the study population will reflect the geographic distributions of the participating institutions.
• Plan for PCNL in the supine position

Критерии исключения

• Active pregnancy
• BMI >45
• Severe Hydronephrosis - renal pelvis diameter > 20mm
• Flank window < 4 cm are ineligible for puncture
• Previous ipsilateral PCNL
• Currently with "useful" nephrostomy tube on ipsilateral side
• Uncorrectable coagulopathies
• Untreated urinary tract infection
• Subjects with significant morbidities such as American Society of Anesthesiologists (ASA) score ≥ 4, severe spinal cord injuries, severe cardiopulmonary insufficiency, uncontrolled diabetes, neurological disorders, bedbound, anticipated life expectancy less than 5 years, or any other comorbidity, that in the opinion of the principal investigator could represent an increased peri-operative risk for the subject;
• Ipsilateral partial nephrectomy
• History of ipsilateral ureteral reimplantation or ureteral reconstruction;
• History of Simple or radical prostatectomy
• History of cystectomy
• History of calyceal diverticula stone;
• History of renal donation or transplant;
• Any other previous pelvic surgical treatment that could put the subject at greater procedural complication risk or technical difficulty;
• Ureteral ipsilateral stricture, untreated;
• Ureteral stricture, untreated (not to include "tight" ureter);
• Any other bladder, ureteral or kidney congenital genitourinary abnormalities (e.g. Horseshoe kidney, ipsilateral duplicated or partially duplicated collecting system, ipsilateral ectopic kidney, cross-fused ectopia, bifid renal pelvis with no horizontally directed calyces, solitary kidney, etc.) preventing the ability to direct a puncture laterally or render the subject stone free;
• Have participated in any other clinical trial within the last 3 months, and/or plans to participate in any other investigational or invasive clinical trial during this study;
• If female, breast-feeding, or if childbearing age, is not using contraception between screening and 90 days post-op;
• Subject has current or recent history of substance abuse (e.g. recreational drugs, narcotics, or alcohol) requiring intervention;
• Is a prisoner or ward of the state;
• Is unable to meet the treatment and follow up protocol requirements.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 2 центра

• University of South Florida — Tampa
• University of Kansas Medical Center — Kansas City

Публикации

• Lee CL, Anderson JK, Monga M. Residency training in percutaneous renal access: does it affect urological practice? J Urol. 2004 Feb;171(2 Pt 1):592-5. doi: 10.1097/01.ju.0000104849.25168.6d. PMID 14713766
• Alotaibi KM. Retrograde nephrostomy access for percutaneous nephrolithotomy: a simple and safe technique. Urolithiasis. 2020 Apr;48(2):175-181. doi: 10.1007/s00240-019-01135-z. Epub 2019 Apr 29. PMID 31037404
• Kaler KS, Parkhomenko E, Lin CY, Valley ZA, Kim WK, Okhunov Z, Patel RM, Landman J. A New Twist on an Old Technique: Lawson Retrograde Endoscopic-Guided Nephrostomy Access for Percutaneous Nephrolithotomy in Prone Split-Leg Position. J Endourol Case Rep. 2018 Nov 29;4(1):190-194. doi: 10.1089/cren.2018.0073. eCollection 2018. PMID 30515460
• Wynberg JB, Paik LJ, Odom BD, Kruger M, Atalla CS. Body mass index predicts outcome of ureteroscopy-assisted retrograde nephrostomy for percutaneous nephrolithotomy. J Endourol. 2014 Sep;28(9):1071-7. doi: 10.1089/end.2014.0204. Epub 2014 Jun 12. PMID 24779944
• Sivalingam S, Al-Essawi T, Hosking D. Percutaneous nephrolithotomy with retrograde nephrostomy access: a forgotten technique revisited. J Urol. 2013 May;189(5):1753-6. doi: 10.1016/j.juro.2012.11.169. Epub 2012 Dec 3. PMID 23219545
• Al-Otaibi KM. Retrograde upper-pole calyceal access for percutaneous nephrolithotripsy of stones in the lower-pole calyx. Arab J Urol. 2012 Dec;10(4):353-7. doi: 10.1016/j.aju.2012.08.002. Epub 2012 Sep 23. PMID 26558049
• Kawahara T, Ito H, Terao H, Kato Y, Uemura H, Kubota Y, Matsuzaki J. Effectiveness of ureteroscopy-assisted retrograde nephrostomy (UARN) for percutaneous nephrolithotomy (PCNL). PLoS One. 2012;7(12):e52149. doi: 10.1371/journal.pone.0052149. Epub 2012 Dec 14. PMID 23251698
• Smiths Textbook of Endourology. 2007, BC Decker Publ. Ch. 15, Dr. D. Hosking - "Retrograde Nephrostomy", Pg. 117.

Идентификаторы

NCT: NCT07071831 · STUDY00160854

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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