Comparison Between Two Methods for Renal Stone Treatment Mini Percutaneous Nephrolithotomy and Flexible Ureteroscopy With Suction Sheath

Официальное название

Flexible Ureteroscopy Using a Tip-Bendable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for the Treatment of 2-3 cm Renal Stones: A Randomized Controlled Trial

Обзор

This study aims to compare the efficacy and safety of two modern, minimally invasive surgical techniques for the removal of kidney stones: Mini-Percutaneous Nephrolithotomy (Mini-PCNL) and Flexible Ureteroscopy (FURS) with Flexible and navigable suction sheath The primary objective is to determine which procedure results in a higher stone-free rate, as measured by post-operative imaging. Secondary objectives include comparing operative time, hospitalization length andcomplication rates between the two treatment groups. Patients with two to three centimeter kidney stones who are candidates for either procedure will be randomly assigned to undergo either Mini-PCNL or suctioning FURS. The outcomes will be critically assessed to help establish a higher level of evidence for guiding surgical management of kidney stones.

Подробное описание

Mini-PCNL involves creating a small tract from the skin on the back directly into the kidney, through which a miniature nephroscope is passed to visualize and remove stones. Flexible Ureteroscopy is performed by passing a thin, flexible scope through the natural urinary passage (urethra and ureter) into the kidney. The specific FURS technique in this study utilizes a specialized scope with integrated suction, which is theorized to improve stone fragment clearance.

Вмешательства

• Процедура mini-percutaneous nephrolithotomy
  Under general anesthesia, a 6 Fr ureteral catheter will be placed into the target ureter via cystoscopy, and bladder drainage will be achieved with a 16 Fr Foley catheter. The patient will then be repositioned to the prone position. Percutaneous renal access will be obtained by puncturing the selected calyx with an 18-gauge coaxial needle under fluoroscopic or ultrasound guidance. Tract dilation will be performed using fascial dilators up to 20 Fr then the mini-PCNL sheath (mini-Amplatz sheath)
• Процедура Flexible Uerteroscopy with Tip-Bendable Suction Sheath
  under general anesthesia with the patient in the lithotomy position. A 6 Fr ureteral catheter will first be placed into the ureter, followed by retrograde pyelography to assess the upper urinary tract. A guidewire will then be advanced into the renal pelvis. either a 12/14 Fr or 11/13 Fr tip-bendable S-UAS will be inserted. If insertion is not possible due to ureteral narrowing, a smaller 10/12 Fr UAS will be attempted. if failed, a double-J stent will be placed and the procedure terminated, wit

Первичные конечные точки

• stone free rate [Срок оценки: one month postoperative]

Вторичные конечные точки (2)

• length of hospital stay [Срок оценки: From date of surgery until date of hospital discharge for 14 days (measured in days).]
• operative time [Срок оценки: Measured intraoperatively, from procedure start to end (in minutes).]

Критерии участия

Критерии включения

• Adult patients aging 18 years old or more.
• Patients with renal stones between 2-3 cm in size confirmed by CT scan.

Критерии исключения

• Patients with previous ureteric injury.
• Patients with uncontrolled diabetes mellitus or hypertension.
• Patients with uncontrolled hepatic dysfunction.
• Patients with uremia or renal failure.
• Pregnant patients.
• patients with active urinary tract infection.
• Patients with bleeding tendency or uncontrolled coagulopathy.
• Patients with congenital anomalies as horse-shoe kidney and pelvi-ureteric junction obstruction.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Ain shams university hospitals — Cairo

Публикации

• Zhu W, Liu S, Cao J, Wang H, Liang H, Jiang K, Cui Y, Chai CA, Sahinler EB, Aquino A, Mazzon G, Zhong W, Zhao Z, Zhang L, Ding J, Wang Q, Wang Y, Chen KW, Liu Y, Choong S, Sarica K, Zeng G. Tip bendable suction ureteral access sheath versus traditional sheath in retrograde intrarenal stone surgery: an international multicentre, randomized, parallel group, superiority study. EClinicalMedicine. 2024 PMID 39070176
• Tang QL, Liang P, Ding YF, Zhou XZ, Tao RZ. Comparative efficacy between retrograde intrarenal surgery with vacuum-assisted ureteral access sheath and minimally invasive percutaneous nephrolithotomy for 1-2 cm infectious upper ureteral stones: a prospective, randomized controlled study. Front Surg. 2023 Jul 7;10:1200717. doi: 10.3389/fsurg.2023.1200717. eCollection 2023. PMID 37483661
• Skolarikos A, Jung H, Neisius A, et al. EAU guidelines on urolithiasis. Arnhem, Netherlands: European Association of Urology; 2024.
• Pauchard F, Ventimiglia E, Corrales M, Traxer O. A Practical Guide for Intra-Renal Temperature and Pressure Management during Rirs: What Is the Evidence Telling Us. J Clin Med. 2022 Jun 15;11(12):3429. doi: 10.3390/jcm11123429. PMID 35743499
• Guven S, Yigit P, Tuncel A, Karabulut I, Sahin S, Kilic O, Balasar M, Seckiner I, Canda E, Sonmez MG, Tefik T, Boz MY, Atis G, Ergin G, Soytas M, Senel C, Kirac M, Kiremit MC, Akand M, Tugcu V, Erkurt B, Muslumanoglu A, Sarica K. Retrograde intrarenal surgery of renal stones: a critical multi-aspect evaluation of the outcomes by the Turkish Academy of Urology Prospective Study Group (ACUP Study). PMID 32347334
• Geraghty R, Abourmarzouk O, Rai B, Biyani CS, Rukin NJ, Somani BK. Evidence for Ureterorenoscopy and Laser Fragmentation (URSL) for Large Renal Stones in the Modern Era. Curr Urol Rep. 2015 Aug;16(8):54. doi: 10.1007/s11934-015-0529-3. PMID 26077357
• Gauhar V, Traxer O, Castellani D, Sietz C, Chew BH, Fong KY, Hamri SB, Gokce MI, Gadzhiev N, Galosi AB, Yuen SKK, El Hajj A, Ko R, Zawadzki M, Sridharan V, Lakmichi MA, Corrales M, Malkhasyan V, Ragoori D, Soebhali B, Tan K, Chai CA, Tursunkulov AN, Tanidir Y, Persaud S, Elshazly M, Kamal W, Tefik T, Shrestha A, Tiong HC, Somani BK. Could Use of a Flexible and Navigable Suction Ureteral Access She PMID 38789313
• Alenezi H, Denstedt JD. Flexible ureteroscopy: Technological advancements, current indications and outcomes in the treatment of urolithiasis. Asian J Urol. 2015 Jul;2(3):133-141. doi: 10.1016/j.ajur.2015.06.002. Epub 2015 Jun 23. PMID 29264133

Идентификаторы

NCT: NCT07306819 · FMASU MS 725/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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