NCT07510178

Retrograde Intrarenal Surgery Versus Extracorporeal Shockwave Lithotripsy

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Sindh Institute of Urology and Transplantation · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Renal Stone
• Stone in Calyceal Diverticulum

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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

Timeline

• Start date: 2026-04-30
• Primary completion: 2026-10-30
• Completion: 2026-10-30
• First posted: 2026-04-03
• Last updated: 2026-04-15

Locations

1 site across 1 country: Pakistan