Flexible Nephroscopy-Assisted Single-Tract Versus Multi-Tract Percutaneous Nephrolithotomy for Complex Renal Stones

Официальное название

Flexible Nephroscopy-Assisted Single-Tract Versus Multi-Tract Percutaneous Nephrolithotomy for Complex Renal Stones: A Prospective, Randomized, Non-Inferiority Trial

Обзор

This randomized, parallel-group, non-inferiority trial will compare flexible nephroscopy-assisted single-tract percutaneous nephrolithotomy with conventional multi-tract percutaneous nephrolithotomy in patients with complex unilateral renal stones. The primary outcome is stone-free rate at 3 months, and secondary outcomes include operative time, fluoroscopy time, hemoglobin drop, transfusion rate, hospital stay, complications, need for auxiliary procedures, and cost-effectiveness.

Подробное описание

This prospective randomized non-inferiority trial will enroll adults aged 18-70 years with complex unilateral renal stones anticipated to require multiple accesses. Participants will be randomized in a 1:1 ratio to either flexible nephroscopy-assisted single-tract PCNL or conventional multi-tract PCNL. The study aims to determine whether the single-tract approach is not inferior to the multi-tract approach with respect to stone-free rate at 3 months, while potentially reducing perioperative morbidity, including bleeding, transfusion, operative time, and length of hospital stay. Secondary analyses will evaluate complication profiles using Clavien-Dindo classification, need for auxiliary procedures, cost-effectiveness, and the predictive value of Guy's Stone Score and S.T.O.N.E. score.

Вмешательства

• Процедура Flexible Nephroscopy-Assisted Single-Tract PCNL
  Single-tract percutaneous nephrolithotomy using flexible nephroscopy through the same tract, with rigid nephroscopy, pneumatic lithotripsy, and Holmium:YAG laser as needed.
• Процедура Conventional Multi-Tract PCNL
  Multi-tract percutaneous nephrolithotomy using rigid nephroscopy through multiple accesses, with pneumatic lithotripsy as needed.

Первичные конечные точки

• Stone-free rate at 3 months. [Срок оценки: 3 months after surgery.]

Вторичные конечные точки (7)

• Operative time [Срок оценки: Intraoperative]
• Fluoroscopy time [Срок оценки: Intraoperative]
• Number of tracts [Срок оценки: Intraoperative]
• Hemoglobin drop [Срок оценки: From baseline to postoperative day 1.]
• Transfusion rate [Срок оценки: Perioperative/Periprocedural]
• Duration of Postoperative Hospitalization [Срок оценки: From the date of PCNL surgery until hospital discharge.]
• Complication rate [Срок оценки: Up to 3 months]

Критерии участия

Критерии включения

• Age 18-70 years.

Unilateral complex renal stones defined by one or more of the following: Guy's Stone Score III-IV, S.T.O.N.E. score ≥9, staghorn or partial staghorn calculus, or stones involving at least 3 calyces on NCCT.

Preoperative expectation of multiple accesses by the surgeon.

Written informed consent.

Критерии исключения

Solitary kidney.

Uncorrected coagulopathy.

Active urinary tract infection.

ASA grade IV or higher.

Pregnancy.

Previous ipsilateral PCNL or open renal surgery.

Stones less than 2 cm or simple calyceal stones.

Refusal or inability to comply with follow-up.

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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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07753733 · UroAzhar_8_026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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