Initial Drainage Method and Flexible Ureteroscopy Outcomes in Calculous Anuria

Официальное название

Impact of Initial Drainage Method on Flexible Ureteroscopy Outcomes in Patients Presenting With Calculous Anuria: A Multicenter Prospective Randomized Controlled Trial

Обзор

Calculous anuria caused by obstructing upper ureteral stones in a solitary functioning kidney is a urological emergency requiring urgent decompression. Both retrograde JJ ureteral stenting and percutaneous nephrostomy are commonly used emergency drainage methods. However, limited evidence is available regarding whether the initial drainage method affects subsequent definitive flexible ureteroscopy/retrograde intrarenal surgery outcomes. This multicenter prospective randomized controlled trial will compare emergency JJ ureteral stent drainage versus percutaneous nephrostomy drainage in adult patients presenting with calculous anuria due to a single upper ureteral stone in a solitary functioning kidney. After renal functional improvement, clinical stabilization, and appropriate urine culture management, all participants will undergo standardized definitive flexible ureteroscopy/retrograde intrarenal surgery. The study will assess renal functional recovery, first-session surgical success, stone-free rate, operative parameters, complications, and microbiological outcomes.

Подробное описание

This is a multicenter prospective randomized controlled trial comparing two emergency drainage strategies before definitive flexible ureteroscopy/retrograde intrarenal surgery in patients presenting with calculous anuria.

Adult patients with calculous anuria caused by a single upper ureteral stone in a solitary functioning kidney will be assessed for eligibility. Eligible participants will be randomized in a 1:1 ratio to emergency retrograde JJ ureteral stent drainage or emergency percutaneous nephrostomy drainage. Randomization will be performed using a computer-generated random sequence, with allocation concealment using sequentially numbered opaque sealed envelopes.

Participants assigned to the JJ stent group will undergo emergency retrograde placement of a 6 Fr JJ ureteral stent under cystoscopic guidance. Participants assigned to the percutaneous nephrostomy group will undergo emergency ultrasound-guided placement of an 8 Fr nephrostomy tube. After drainage, participants will be monitored for urine output recovery, renal functional improvement, symptom relief, and clinical stabilization.

Definitive flexible ureteroscopy/retrograde intrarenal surgery will be scheduled after renal functional improvement, clinical stabilization, and negative or appropriately treated urine culture. The definitive procedure will be performed using a standardized operative strategy. Ureteral access sheath use, successful insertion, need for adjunctive ureteral maneuvers, operative time, laser time, fluoroscopy time, postoperative stenting, complications, and hospital stay will be recorded.

The primary outcome is renal functional recovery after initial drainage and definitive surgery, assessed using serial serum creatinine measurements at presentation, 24 to 48 hours after drainage, before definitive surgery, postoperative day 1, and follow-up. Secondary outcomes include first-session definitive surgery success, stone-free rate, technical operative variables, intraoperative and postoperative complications, microbiological culture patterns, and predictors of surgical success or postoperative complications.

Participants will be followed for approximately one month after definitive surgery by clinical assessment, laboratory evaluation, and imaging for assessment of renal function, complications, and stone clearance.

Вмешательства

• Процедура Initial JJ Ureteral Stent Drainage
  Retrograde cystoscopic placement of a 6 Fr JJ ureteral stent for initial upper urinary tract decompression in patients presenting with calculous anuria due to a single upper ureteral stone in a solitary functioning kidney. After renal functional improvement, clinical stabilization, and appropriate urine culture management, participants will undergo standardized definitive flexible ureteroscopy/retrograde intrarenal surgery.
• Процедура Initial Percutaneous Nephrostomy Drainage
  Ultrasound-guided placement of an 8 Fr percutaneous nephrostomy tube for initial upper urinary tract decompression in patients presenting with calculous anuria due to a single upper ureteral stone in a solitary functioning kidney. After renal functional improvement, clinical stabilization, and appropriate urine culture management, participants will undergo standardized definitive flexible ureteroscopy/retrograde intrarenal surgery.

Первичные конечные точки

• Change in Serum Creatinine From After Initial Drainage to After Definitive RIRS [Срок оценки: From 24-48 hours after initial drainage to postoperative day 1 after definitive RIRS]

Вторичные конечные точки (6)

• First-Session Definitive RIRS Success Rate [Срок оценки: During the definitive RIRS procedure]
• Stone-Free Rate After Definitive RIRS [Срок оценки: 4 weeks after definitive RIRS]
• During the definitive RIRS procedure [Срок оценки: During the definitive RIRS procedure]
• Need for Ureteral Stenting After Definitive RIRS [Срок оценки: At the end of the definitive RIRS procedure]
• Intraoperative Complications During Definitive RIRS [Срок оценки: During the definitive RIRS procedure]
• Postoperative Infectious Complications After Definitive RIRS [Срок оценки: From definitive RIRS to 4 weeks after definitive RIRS]

Критерии участия

Критерии включения

• Adults aged 18 years or older.
• Calculous anuria secondary to a single upper ureteral stone.
• Solitary functioning kidney, whether anatomical or functional.
• Single upper ureteral stone confirmed by non-contrast computed tomography.
• Stone size from 6 mm to 20 mm in maximum diameter.
• Patient considered suitable for either initial JJ ureteral stent drainage or percutaneous nephrostomy drainage.
• Candidate for definitive treatment by flexible ureteroscopy/retrograde intrarenal surgery.
• Documented renal functional improvement and clinical stabilization before definitive RIRS.
• Negative or appropriately treated urine culture before definitive RIRS.
• Ability and willingness to provide written informed consent.

Критерии исключения

• Multiple stones or bilateral stones not fitting the solitary-kidney study design.
• Renal pelvic, distal ureteral, or multiple ipsilateral stones.
• Stone burden greater than 20 mm.
• Septic shock, hemodynamic instability, or need for emergency dialysis at presentation.
• Pyonephrosis requiring a non-randomized drainage decision.
• Anatomical abnormalities affecting endoscopic access, such as horseshoe kidney, pelvic kidney, ureterocele, or ureteral stricture.
• Previous ipsilateral ureteral reconstructive surgery.
• Uncorrected coagulopathy.
• Pregnancy.
• Genitourinary malignancy.
• Inability to complete follow-up.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 3 центра

• Department of Urology- Beni-Suef University Hospitals — Banī Suwayf
• Department of Urology- Minia University Hospitals — Minya
• Department of Urology- Tanta University Hospitals — Tanta

Идентификаторы

NCT: NCT07627880 · FMB050526-ANURIA-RIRS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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