Suction Mini-PCNL Versus Standard PCNL for the Management of 2-4cm Kidney Stones
1 other identifier
interventional
960
1 country
1
Brief Summary
Percutaneous nephrolithotomy (PCNL) was the first line choice for the management of renal calculi larger than 20 mm. A relative large tract of 24-30Fr was widely used in standard PCNL (sPCNL), which was believed to bring tract-related bleeding. In order to reduce the risk of tract-related bleeding, Chinese urologists used 18Fr mini-tract in the PCNL procedures, which was well known as minimally invasive percutaneous nephrolithotomy (mini-PCNL). In an international multi-centre randomized controlled trail (RCT) , mini-PCNL and sPCNL was compared in the management of 2-4cm kidney stones, the stone free rate (SFR) in mini-PCNL was equal to that of sPCNL. However, since the tract was smaller, the postoperative pain in mini-PCNL was less, the postoperative recovery was faster, and the hospital stay was shorter. Recently, professor Guohua Zeng developed enhanced super-mini-PCNL (eSMP) technique. When compared to traditional mini-PCNL, suction mini-PCNL using 18Fr suction sheath increased the stone removal efficiency and reduced the renal pelvic pressure. While in the present regard, whether suction mini-PCNL play an more efficent and safe role in the management of 2-4cm kidney stones was worthy of further study. So, the investigators would like to have an international multi-centre RCT to certify our hypothesis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2021
CompletedFirst Posted
Study publicly available on registry
October 21, 2021
CompletedStudy Start
First participant enrolled
December 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedOctober 21, 2021
October 1, 2021
1.3 years
October 3, 2021
October 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Stone free rate (SFR)
2mm Non-contrast CT is obtained for all patients at one 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 definded as ≤ 4mm, asymptomatic, non-obstructive and non-infectious stone particles.
1 month after removing the pigtail stent
Operation time
Operation time was defined as the time from puncture to the placement of the nephrostomy tube.
the time from puncture to the placement of the nephrostomy tube
Secondary Outcomes (2)
Lithotripsy time
the time for lithotripsy only
Postoperative fever and other complications
intraoperatively or ≤ 1month postoperatively
Study Arms (2)
Patients in Group 1 undergo suction mini percutaneous nephrolithotomy
EXPERIMENTALPatients in Group 2 undergo standard percutaneous nephrolithotomy
EXPERIMENTALInterventions
18Fr suction sheath (Weili, China) was inserted, and 12Fr mini-nephroscope was used, kidney stones was fragmented by pneumatic lithotriptor (LithoClast Master, Switzerland) or Ho:YAG laser（0.8-1.0W\*20-30Hz）, and stone fragments was sucked out with the suction sheath.
24-30Fr sheath was inserted, and 20Fr nephroscope (Richard Wolf, Germany) was used, kidney stones was disintegrated and sucked out by ultrasonic-lithotripter (LithoClast Master, EMS, Switzerland or ShockPluse-SE, Olympus).
Eligibility Criteria
You may qualify if:
- Patients consent for percutaneous renal stone removal.
- Kidney stones 2-4cm.
- Aged 18-70 years.
- Normal renal function.
- ASA scoreⅠ-Ⅱ.
You may not qualify if:
- Severe cardiopulmonary dysfunction or cardiopathy.
- Coagulation dysfunction.
- Pyonephrosis or severe acute infection.
- Transplanted kidney, solitary kidney, horseshoe kidney, urinary diversion, urethra deformity.
- Other procedure was required in the same session of operation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The First Affiliated Hospital of Guangzhou Medical Universitylead
- Aceves of Wake Forest University Medical Centercollaborator
- University College London Hospitalcollaborator
- San Paolo Hospital, University of Milancollaborator
- Örebro University, Swedencollaborator
- San Bassiano Hospital, Vicenza, Italycollaborator
- ALAMIRI Hospital, SABAH ALAHMAD Urology Center, Kuwaitcollaborator
- Biruni University Medical School, İstanbul, Turkeycollaborator
- Jose R. Reyes Memorial Medical Center, Manila, Philippines.collaborator
- Military Medical Academy, Bulgariacollaborator
- The First Affiliated Hospital of Anhui Medical Universitycollaborator
- First Affiliated Hospital of Chongqing Medical Universitycollaborator
- Zunyi Medical Collegecollaborator
- The First Affiliated Hospital of Nanchang Universitycollaborator
- Renmin Hospital of Wuhan Universitycollaborator
- Wuhan Universitycollaborator
- The Jiangxi Provincial People's Hospitalcollaborator
- Affiliated Hospital of Guangdong Medical Universitycollaborator
- ZhuHai Hospitalcollaborator
- People's Hospital of Guangxi Zhuang Autonomous Regioncollaborator
- Xiangtan Central Hospitalcollaborator
- First People's Hospital of Foshancollaborator
Study Sites (1)
Department of Urology, Minimally invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510230, China
Related Publications (2)
Zeng G, Cai C, Duan X, Xu X, Mao H, Li X, Nie Y, Xie J, Li J, Lu J, Zou X, Mo J, Li C, Li J, Wang W, Yu Y, Fei X, Gu X, Chen J, Kong X, Pang J, Zhu W, Zhao Z, Wu W, Sun H, Liu Y, la Rosette J. Mini Percutaneous Nephrolithotomy Is a Noninferior Modality to Standard Percutaneous Nephrolithotomy for the Management of 20-40mm Renal Calculi: A Multicenter Randomized Controlled Trial. Eur Urol. 2021 Jan;79(1):114-121. doi: 10.1016/j.eururo.2020.09.026. Epub 2020 Sep 29.
PMID: 32994063RESULTZhong W, Wen J, Peng L, Zeng G. Enhanced super-mini-PCNL (eSMP): low renal pelvic pressure and high stone removal efficiency in a prospective randomized controlled trial. World J Urol. 2021 Mar;39(3):929-934. doi: 10.1007/s00345-020-03263-3. Epub 2020 May 26.
PMID: 32458093RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guohua Zeng, Ph.D & MD
The First Affiliated Hospital of Guangzhou Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice president
Study Record Dates
First Submitted
October 3, 2021
First Posted
October 21, 2021
Study Start
December 1, 2021
Primary Completion
April 1, 2023
Study Completion
December 1, 2023
Last Updated
October 21, 2021
Record last verified: 2021-10