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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02635048
Recruitment Status : Completed
First Posted : December 18, 2015
Last Update Posted : March 5, 2020
Sponsor:
Collaborators:
Baoshan No.2 People's Hospital
The Second Affiliated Hospital of Harbin Medical University
First Affiliated Hospital of Fujian Medical University
People's Hospital of Nanhai District, Foshan
Yichang Yiling Hospital
Suzhou Municipal Hospital
First Affiliated Hospital of Gannan Medical University
General Hospital of Shenyang Military Region
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
The Second Affiliated Hospital of Kunming Medical University
Chui Yang Liu Hospital affiliated to Tsinghua University
Fujian Medical University Union Hospital
Shengjing Hospital
181st hospital of Chinese People's Liberation Army
First Affiliated Hospital of Guangxi Medical University
Jiangmen Central Hospital
China-Japan Union Hospital, Jilin University
The Sixth Affiliated Hospital of Guangzhou Medical University
Shandong Jining No.1 People's Hospital
Information provided by (Responsible Party):
Guohua Zeng, The First Affiliated Hospital of Guangzhou Medical University

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 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1980 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Arm Intervention/treatment
Group 1
Patients in Group 1 undergo mini percutaneous nephrolithotomy
Procedure: Mini Percutaneous Nephrolithotomy
patients undergo PNCL with 18Fr nephrostomy tract

Group 2
Patients in Group 2 undergo percutaneous nephrolithotomy
Procedure: Percutaneous Nephrolithotomy
patients undergo PNCL with 24Fr nephrostomy tract




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients consent for percutaneous renal stone removal
  2. Age 18 to 70 years
  3. Normal renal function
  4. ASA score Ⅰ and Ⅱ
  5. Renal stones 20-40mm

Exclusion Criteria:

  1. Patients with solitary kidney.
  2. Uncorrected coagulopathy and active urinary tract infection (UTI)
  3. Morbid obese patients
  4. Patients who underwent transplant or urinary diversion.
  5. Congenital abnormalities.

Information from the National Library of Medicine

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


Locations
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China, Guangdong
Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510230
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University
Baoshan No.2 People's Hospital
The Second Affiliated Hospital of Harbin Medical University
First Affiliated Hospital of Fujian Medical University
People's Hospital of Nanhai District, Foshan
Yichang Yiling Hospital
Suzhou Municipal Hospital
First Affiliated Hospital of Gannan Medical University
General Hospital of Shenyang Military Region
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
The Second Affiliated Hospital of Kunming Medical University
Chui Yang Liu Hospital affiliated to Tsinghua University
Fujian Medical University Union Hospital
Shengjing Hospital
181st hospital of Chinese People's Liberation Army
First Affiliated Hospital of Guangxi Medical University
Jiangmen Central Hospital
China-Japan Union Hospital, Jilin University
The Sixth Affiliated Hospital of Guangzhou Medical University
Shandong Jining No.1 People's Hospital
Investigators
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Principal Investigator: Guohua Zeng, PH.D & MD The First Affiliated Hospital of Guangzhou Medical University
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Responsible Party: Guohua Zeng, Vice president, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT02635048    
Other Study ID Numbers: MRER(67)2015
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020
Keywords provided by Guohua Zeng, The First Affiliated Hospital of Guangzhou Medical University:
Percutaneous nephrolithotomy
Kidney stones
Efficacy
Safety
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Calculi
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Pathological Conditions, Anatomical