Clinical Trial: SMP vs RIRS for Symptomatic Lower Pole Renal Calculi of 10-20 mm Size: a Randomized Controlled Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Super-Mini Percutaneous Nephrolithotomy (SMP) Versus Retrograde Intrarenal Surgery (RIRS) for Symptomatic Lower Pole Renal Calculi of 10-20 mm Size: a Randomized Controlle

Brief Summary:

Shock wave lithotripsy (SWL) is recommended for kidney stones < 20 mm. However, the stone clearance of lower pole calculi after SWL is limited, thus leading to an extended indication for mini-percutaneous nephrolithotripsy (PCNL) even for stones between 10 and 20 mm in many centers. This trend is further promoted by introduction of super-mini PCNL (SMP), which is postulated to be less invasive compared to mini-PCNL due to the miniaturized instruments. However, this issue remains controversial.

On the other hand, improvements in endoscopy technology have made retrograde stone removal more attractive. This has led to an increasing use of RIRS as a primary treatment although it is recommended only as 2nd-line option by current guidelines. However, the treatment of symptomatic lower pole calculi is a challenge for RIRS because of lower clearance rates.

The purpose of this study is to evaluate the efficacy and safety of SMP and RIRS for the treatment for symptomatic lower pole calculi renal calculi measuring 10-20 mm.


Detailed Summary:

To evaluate the efficacy and safety of SMP and RIRS for the treatment for symptomatic lower pole calculi renal calculi measuring 10-20 mm.Investigators will do a multi-centers international randomized controlled trial(RCT)，and investigators plan to perform this study in 10 hospitals，which are the First Affiliated Hospital of Guangzhou Medical University of China, Department of Urology, Renmin Hospital, Wuhan University of China, Shenzhen People's Hospital of China, The Second Affiliated Hospital of Zhengzhou University of China, The Second Affiliated Hospital of Harbin Medical University of China, Zhujiang Hospital of Southern Medical University of China, Jiangsu Province hospital, The First Affiliated Hospital With Nanjing Medical University of China, Zhejiang provincial people's hospital of china, Dr. Lutfi Kirdar Training and Research Hospital of Turkey and Global Rainbow Healthcare of India respectively.

Investigators plan to beginning their study at August in 2015 and end at July in 2016.One hundred and sixty patients with symptomatic lower pole calculi renal calculi measuring 10-20 mm will be enrolled in this study. By simple random sampling technique, patients will be assigned to two 80-patient groups.All the patients will be diagnosed definitely before operations with non-contrast CT.Patients with positive preoperative urine culture should be treated with suitable antibiotics based on the culture sensitivity result for at least 72h before SMP/RIRS. Patients who have negative urine culture should receive a single dose of broad spectrum antibiotic prophylaxis just prior to the procedure.

Surgical technique

SMP

All the biochemistry tests and preoperative preparations are referenced to the mini-PCNL. Under
Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Current Primary Outcome: Stone free rate (SFR) [ Time Frame: One day after procedure ]

Primary SFR is assessed by abdominal plain film （KUB） at day 1 after operation.Stone-free status are defined as either the absence of any residual stone fragments or the presence of clinically insignificant residual stone fragments in the kidney which were defined as ≦ 3mm, asymptomatic, non-obstructive and non-infectious stone particles.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Perioperative complications [ Time Frame: intraoperatively or ≤ 1 month postoperatively ]
    Complication is defined as any adverse event occurred intraoperatively or ≤1 month postoperatively.
  • Operation time [ Time Frame: intraoperatively ]

    For SMP: recorded from the time of the first percutaneous renal puncture to the completion of the stone removal.

    For RIRS: recorded from insertion of an endoscope into the urethra to the completion of stent placement.



Original Secondary Outcome: Same as current

Information By: The First Affiliated Hospital of Guangzhou Medical University

Dates:
Date Received: August 3, 2015
Date Started: August 2015
Date Completion: July 2017
Last Updated: August 6, 2015
Last Verified: August 2015