Clinical Trial: Mini-PCNL Versus Standard-PCNL For The Management of 20-40 mm Size Kidney Stones

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

Official Title: Efficacy and Safety of Mini-PCNL Versus Standard-PCNL For The Management of 20-40 mm Size Kidney Stones: A Multi-center Randomized Controlled Trial

Brief Summary:

Percutaneous nephrolithotomy (PCNL) has been considered as the first-line choice for the management of >20mm kidney stones. The traditional nephrostomy tract of PNL was dilated to 24-30F, which is referred to as "Standard-PCNL". Standard PNL has an ideal stones free rate (SFR), however, at the cost of severe morbidity. To decrease the disadvantages related to standard PNL, "mini-perc" or "mini-PCNL", 20F or less, was first introduced to pediatric procedure in 1997, and subsequently implemented in adults with the expectation of similar SFR and low morbidity in the past twenty years. Although abundant efforts have been done, whether mini-perc outweigh standard-PNL for the treatment of >20mm calculis in terms of efficiency and safety remains controversial.

To solve this problem, we performed this multi-center randomized controlled trial (RCT).


Detailed Summary:

To evaluate the efficacy and safety of mini-PCNL versus standard-PCNL for the management of 20-40 mm size kidney stones.Investigators plan to do a multi-center international randomized controlled trial(RCT). There are 44 hospitals included in this study, including The First Affiliated Hospital of Guangzhou Medical University, Shenzhen People's Hospital, The First Affiliated Hospital of Guangxi Medical University, Affiliated Hospital of Guilin Medical University, The first people's Hospital of Kashi, The First People's Hospital of Yulin, The Central Hospital of Shaoyang, Jiangmen Central Hospital, People's Hospital of Nanhai District, Foshan, The second Affiliated Hospital of Kunming Medical University, The First Affiliated Hospital of Nanhua University,Luoding People's Hospital, Qingyuan People's Hospital, The second Affiliated Hospital of Harbin Medical University, Chongqing Daping Hospital, Zhuzhou Central Hospital, HuiZhou Municipal Central Hospital, Jining NO.1 People's Hospital, Suzhou Municipal Hospital, The General Hospital of Shenyang Military, The Second Affiliated Hospital of Soochow University, ShengJing Hospital Of China Medical University, Yichang Yiling Hospital, Jiangsu Province Hospital, Beijing Chuiyangliu Hospital, Renji Hospital Shanghai Jiaotong University School of Medicine, The First Affiliated Hospital of Gannan Medical University, The First Affiliated Hospital of Fujian Medical University, Fuling Center Hospital of Chongqing City, Baoshan No.2 People's Hospital, Fujian Medical University Union Hospital, Shanghai General Hospital, The First Affiliated Hospital of Xiamen University, 181st hospital of Chinese People's Liberation Army, Danyang People's Hospital of Jiangsu Province, The fifth hospital of People's Liberation Army, Affiliated Hospital of Hebei University, The 159th Central Hospital of People's Liberation Army, Guizhou Provincial People's Hospital, Venus International Hospital, Lions Kidn
Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Current Primary Outcome: Stone free rate (SFR) [ Time Frame: 1 month after the procedure ]

Non-contrast CT is obtained for all patients at 1 month after the operation to evaluate the final SFR, allowing time for the spontaneous passage of stone fragments. 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 ≦ 4mm, 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, including intraoperative bleeding, postoperative pain and so on.


Original Secondary Outcome: Same as current

Information By: The First Affiliated Hospital of Guangzhou Medical University

Dates:
Date Received: December 16, 2015
Date Started: December 2015
Date Completion: November 2017
Last Updated: December 17, 2015
Last Verified: December 2015