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临床试验/NCT07510178
NCT07510178尚未招募不适用

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

Sindh Institute of Urology and Transplantation1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2026年4月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
66
试验地点
1
主要终点
Stone clearance

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Group A

Active Comparator

Group A will be comprised of those patients who will be treated by ESWL (shockwave lithotripsy).

干预措施: Extracorporeal shock wave lithotripsy (Procedure)

Group B

Experimental

Group B will be comprised of those patients who will be treated by RIRS (retrograde intrarenal surgery).

干预措施: Retrograde intrarenal surgery (Procedure)

结局指标

主要结局

Stone clearance

时间窗: four weeks after the intervention

Stone clearance (based on follow-up with X-Ray for radio-opaque stones and ultrasound or CT Scan for radio-lucent stones)

次要结局

  • Hematuria(within 4 weeks after the intervention)
  • Urinary tract infection(within 4 weeks after the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maaz Bin Nazir

Resident

Sindh Institute of Urology and Transplantation

研究点 (1)

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