Retrograde Intrarenal Surgery Versus Extracorporeal Shockwave Lithotripsy

Официальное название

Role Of Retrograde Intrarenal Surgery Versus Extracorporeal Shockwave Lithotripsy In Lower Calyceal Calculi

Обзор

The study's aim is to determine which treatment modality, either ESWL or RIRS, is more effective in achieving stone clearance for lower calyceal calculi. Investigators hypothesize that retrograde intrarenal surgery is better as compared to extracorporeal shockwave lithotripsy. It will target those patients suffering from kidney stones in lower calyces with sizes up to 1.5 cm in an open-label, randomized controlled trial.

Подробное описание

After approval from the Institutional Ethical Review Committee and taking informed consent from the patients, the investigator will gather all the information related to the study. Patients will be enrolled in this study from the outpatient clinic. Total patients will be divided into two groups using the SNOSE protocol, in which patients will be randomly assigned to one of the two groups using the envelope method.

Group A will be labeled under those patients who will be treated by ESWL. Group B will be those treated by RIRS. It will be an open-label study. A Performa has been designed and finalized after a literature search. This form will gather demographic details, clinical characteristics, selection of procedure, procedure details, outcomes of procedure, and complications.

In case of ESWL, up to 3 sessions of ESWL will be given, and for RIRS, only one session will be considered. In ESWL, ultrasound- or fluoroscopy-guided 3000 shock waves per person are delivered under the supervision of an experienced consultant urologist for up to 60 - 90 minutes using lithotripsy model SLX-F2 FD21 with energy ranging from 1 to 6, and patients are discharged on proper hydration, painkillers, and alpha blockers. In RIRS, firstly, a retrograde pyelogram is performed to know the anatomy and stone position. Then, using aseptic technique, a sterile flexible 7.5/3.6 Fr ureterorenoscope of model HU30S will be passed over a Y-9-50 ureteral access sheath and advanced into the kidney, and the stone will be broken with the use of a 35-watt hyperphotonic holmium laser delivered via a 272 nm fiber. The RIRS will be performed by an experienced urologist. Later patients will be discharged with advice of hydration and empirical antibiotics. Initially the stone bulk will be defined by a CT scan, and the Hounsfield unit of stones will be noted. The infundibular pelvic angle, calyx length, diameter, and skin-to-stone distance will also be calculated using the CT scan plane. Patients managed either by RIRS or ESWL will be advised for a follow-up after four weeks with an X-ray KUB for radiopaque stones and an ultrasound and CT scan of the kidneys to look for residual radiolucent calculi. Stone clearance will be considered if residual stone size is less than 4 mm.

Вмешательства

• Процедура Retrograde intrarenal surgery
  Retrograde intrarenal surgery (RIRS) is a minimally invasive procedure in which a flexible ureteroscope is passed through the urethra, then the ureter, and then into the kidney, and then with the help of the laser, stones are broken down into small fragments, which can be retrieved either at the same time or flushed later in urine. Stone clearance will assessed with an X-ray of the abdomen (radiopaque) and ultrasound or CT scan of the kidneys (residual radiolucent stones) on follow-up.
• Процедура Extracorporeal shock wave lithotripsy
  Extracorporeal shock wave lithotripsy (ESWL) is a noninvasive procedure in which highly focused shock waves are delivered at the renal calculi, which then break down into small pieces and later pass in urine. An X-ray abdomen (radiopaque) and ultrasound or CT scan of the kidneys (residual radiolucent stone) will be used on follow-up to assess stone clearance. Up to 3 sessions of ESWL will given to the selected candidate

Первичные конечные точки

• Stone clearance [Срок оценки: four weeks after the intervention]

Вторичные конечные точки (2)

• Urinary tract infection [Срок оценки: within 4 weeks after the intervention]
• Hematuria [Срок оценки: within 4 weeks after the intervention]

Критерии участия

Критерии включения

• Those patients will be included with lower calyceal renal stones and size up to 1.5 cm.
• Patients' ages will be between 18 and 60 years.
• Both genders will be included.

Критерии исключения

• Untreated Urine culture positive will be excluded
• Patients using anticoagulants and females with pregnancies and those lactating will be excluded.
• Anatomical abnormalities like horseshoe kidney, duplex system, pelvic kidney, malrotated kidney, calyceal diverticulum, steep infundibulopelvic angle, infundibular stenosis, long infundibular length/narrow infundibular width, pelvic ureteric junction obstruction, ureterocele, and ureteral stricture will be excluded.

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

Пакистан · 1 центр

• Sindh Institute of Urology and Transplantation — Karachi

Идентификаторы

NCT: NCT07510178 · SIUT-ERC-2025/A-612

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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