Mini-PCNL Versus Standard-PCNL For The Management of 20-40 mm Size Kidney Stones
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|ClinicalTrials.gov Identifier: NCT02635048|
Recruitment Status : Completed
First Posted : December 18, 2015
Last Update Posted : March 5, 2020
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 multicenter, parallel, open-label randomized controlled trial (RCT).
|Condition or disease||Intervention/treatment||Phase|
|Kidney Calculi||Procedure: Mini Percutaneous Nephrolithotomy Procedure: Percutaneous Nephrolithotomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1980 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||January 1, 2016|
|Actual Primary Completion Date :||August 1, 2019|
|Actual Study Completion Date :||August 20, 2019|
Patients in Group 1 undergo mini percutaneous nephrolithotomy
Procedure: Mini Percutaneous Nephrolithotomy
patients undergo PNCL with 18Fr nephrostomy tract
Patients in Group 2 undergo percutaneous nephrolithotomy
Procedure: Percutaneous Nephrolithotomy
patients undergo PNCL with 24Fr nephrostomy tract
- Stone free rate (SFR) [ Time Frame: 1 month after removing the pigtail stent ]2mm Non-contrast CT is obtained for all patients at 1 month after removing the pigtail stent to evaluate the final SFR. 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635048
|Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University|
|Guangzhou, Guangdong, China, 510230|
|Principal Investigator:||Guohua Zeng, PH.D & MD||The First Affiliated Hospital of Guangzhou Medical University|