Standard PCNL Vs Endoscopic Combined Intrarenal Surgery (ECIRS) for Complex Nephrolithiasis in Obese Patients

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-25

Study Completion Date

2024-01-31

Brief Summary

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Primary aim: comparing the efficacy of standard PCNL and endoscopic combined intrarenal surgery (ECIRS) in the Galdakao-modified Supine Valdivia (GMSV) position in a single session for the treatment of complex nephrolithiasis in obese patients.

Secondary aim: comparing safety and complications of standard PCNL and ECIRS in the GMSV.

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Detailed Description

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Complex nephrolithiasis including multiple peripheral or branched (partial or complete staghorn calculi) renal stones, is still currently an intractable problem for urologists to achieve stone-free status and minimize complication rates. According to the European Association of Urology Urolithiasis Guidelines, retrograde intrarenal surgery (RIRS) is recommended as first-line treatment for renal stones \< 2 cm, and percutaneous nephrolithotomy (PCNL) is recommended as the gold standard for renal stones ≥ 2 cm in length.

Obesity has been identified as an independent risk factor for stone formation in the United States. Obesity (BMI \>35) also places surgical patients at a greater risk of complications, because of the increased incidence in this group of diabetes, hypertension, ischemic heart disease, postoperative deep venous thrombosis, and pulmonary embolism, and because of poor radiographic visualization, obscure anatomic landmarks, more difficult renal access, and inferior stone-free rates.

Standard percutaneous nephrolithotomy (PCNL) is the recommended treatment by major guidelines. However, multiple tracts or sessions of PCNL were required to obtain a high stone-free rate (SFR) for complex renal calculi, especially staghorn stones, while procedure-related complications increased concomitantly. To acquire a higher SFR, full access to the entire intrarenal collecting system is the final goal of treatment for these patients suffering from multiple calyceal or peripheral satellite calculi, which is technically challenging by means of RIRS or PCNL monotherapy.

Conditions

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Renal Stone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

1st patient in the PCNL group , 2nd patient in ECIRS group and so on .

Study Groups

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Percutaneous nephrolithotomy

the standard-PCNL group (will be performed by urologists with more than 2 years of experience of PCNL), Fluoroscopic-guided percutaneous renal access will be done for patients in the prone position.

Group Type ACTIVE_COMPARATOR

Percutaneous nephrolithotomy

Intervention Type PROCEDURE

Clearance of renal stone with nephroscope in prone position

Endoscopic combined intrarenal surgery

the ECIRS group (will be performed by urologists with more than 2 years of experience of PCNL and RIRS), patients will be oriented in the GMSV position.flexible ureteroscope will be inserted through the access sheath to observe the stone distributions. Under the guidance of fluoroscopy and endoscopic vision, a 18-20 Fr percutaneous tract will be established using sequential fascial dilators and a matching sheath for stone manipulation simultaneously. We use a 12-F nephroscope (Karl Storz).

Group Type ACTIVE_COMPARATOR

Endoscopic combined intrarenal surgery

Intervention Type PROCEDURE

Combined complex stone clearance with mini-nephroscope and flexible URS

Interventions

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Endoscopic combined intrarenal surgery

Combined complex stone clearance with mini-nephroscope and flexible URS

Intervention Type PROCEDURE

Percutaneous nephrolithotomy

Clearance of renal stone with nephroscope in prone position

Intervention Type PROCEDURE

Other Intervention Names

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ECIRS PCNL

Eligibility Criteria

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Inclusion Criteria

* Partial or complete staghorn stones)
* Guy's Stone Score III or IV)
* Adult (18-60) years old patients
* Obese \& super-obese patients (BMI \> 30 kg/m 2).