Using Retrograde Intrarenal Surgery for Managing Staghorn Renal Stones.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-20

Study Completion Date

2026-12-01

Brief Summary

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This prospective, randomized study is comparing the safety and efficacy of using two types of ureteral access sheaths in managing staghorn renal stones by retrograde intrarenal surgery.

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Detailed Description

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Staghorn renal calculi is a complex type of renal calculi characterized by their filling of the renal pelvis and branching into all or part of the renal calyces.

Percutaneous nephrolithotomy (PCNL) is currently the recommended primary treatment option for staghorn renal calculi. However, the procedure has significant drawbacks, including invasiveness, postoperative bleeding, infection, prolonged hospitalization, and slow recovery. Retrograde Intrarenal Surgery (RIRS), an effective minimally invasive procedure, has become the first-line treatment for stones smaller than 2cm. With advancements in endoscopic equipment and techniques, RIRS is also being gradually utilized for the treatment of staghorn renal calculi in patients who are not suitable for PCNL.

Ureteral access sheath (UAS) is an important tool for the endourologist. Advantages of using a UAS in ureteroscopy include: ena¬bling repeated passage of the ureteroscope while mini¬mizing damage, improving the flow of irrigation fluid and visualization within the ureter, reducing operative times, reducing the costs of procedures and improving the effectiveness of surgery.

Intending to overcome the shortages of RIRS, a patented ureter access sheath with features of suction and bendable-tip is designed. The tip of the innovated ureteral access sheath can reach the target calyx along with the flexible ureteroscope.

The adjustable continuous negative pressure suction ensures sufficient irrigation speed and maintains a clear surgical field of view, while effectively removing fragmented stones and dust, and reducing the thermal energy generated by laser lithotripsy.

Conditions

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Renal Calculi

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group (1): Retrograde intrarenal surgery using a bendable tip-suction ureteral access sheath

During retrograde intrarenal surgery, an ureteral access sheath with bendable tip \& connected to suction system will be used.

Group Type ACTIVE_COMPARATOR

Retrograde intrarenal surgery

Intervention Type PROCEDURE

Retrograde intrarenal surgery with using laser for management of renal staghorn stones

Group (2): Retrograde intrarenal surgery using a conventional ureteral access sheath

During retrograde intrarenal surgery, a conventional ureteral access sheath will be used.

Group Type PLACEBO_COMPARATOR

Retrograde intrarenal surgery

Intervention Type PROCEDURE

Retrograde intrarenal surgery with using laser for management of renal staghorn stones

Interventions

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Retrograde intrarenal surgery

Retrograde intrarenal surgery with using laser for management of renal staghorn stones

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adult patients of both sexes.
* Patient has a staghorn renal stone (complete or partial staghorn).
* Normal renal function tests.
* Congenital renal anomalies as horseshoe, pelvic or mal-rotated kidneys.

Exclusion Criteria

* Abnormal coagulation profile.
* Active or untreated urinary tract infection.
* Age under 18 years or above 70 years.
* Patient has a staghorn stone associated with other pathology which requires additional intervention, as ureteral stricture or ureteropelvic junction obstruction (UPJO).
* Pregnancy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No