Suction Mini-PCNL Versus Standard PCNL for the Management of 2-4cm Kidney Stones

NCT05088213 | Completed

• 1 other identifier: GMU Multicentre RCT
• Study Type: interventional
• Target: 960
• Locations: 1 country
• Sites: 1

Brief Summary

Percutaneous nephrolithotomy (PCNL) is recommended as the first-line treatment choice for kidney stones larger than 2cm in international guidelines . However, tract-related complications affecting renal parenchymal and blood vessels have always been a concern . The mini-PCNL technique which uses a smaller tract (≤18 Fr) has been introduced to decrease tract-related complications . Nevertheless, the smaller mini-PCNL tract necessitates fragmentationi of stones into smaller pieces before extraction, potentially prolonging the operative time. Additionally, higher pressure irrigation is often required to flush out fragments by vacuum cleaner effect. If the drainage of irrigation fluid is insufficient via a smaller tract, the intrarenal pressure (IRP) may build up, leading to pyelovenous backflow and infectious complications. Suction application in mini-PCNL has the potential to enhance stone fragments removal efficiency, maintain low IRP, and decrease potential postoperative infection complications. In the pre-suction era, mini-PCNL achieved noninferior stone-free rates (SFR) and operative times compared to standard PCNL, along with benefits of reduced bleeding, less postoperative pain, and shorter hospital stay. However, high-level evidence regarding whether suction mini-PCNL can attain comparable outcomes to standard PCNL is still lacking. Therefore, we have designed this multicenter, international, randomized controlled noninferiority trial comparing suction mini-PCNL with standard PCNL in the management of 2-4 cm kidney stones.

Conditions

Kidney Calculi

Keywords

Percutaneous nephrolithotomy; suction; mini PCNL; renal stones

Outcome Measures

Primary Outcomes (2)

• Stone free rate (SFR)

  Immediate postoperative SFR is defined as the absence of residual stone or fragments \<2 mm on low-dose NCCT scan within 72 h after operation.

  72 hours after operation

• Operation time

  Operative time is defined as the time from percutaneous puncture to completion of double-J or nephrostomy tube placement.

  the time from percutaneous puncture to completion of double-J or nephrostomy tube placement

Secondary Outcomes (5)

• Final SFR

  1 month post intervention

• Pain VAS score

  VAS is evaluated at three time points, namely pre-operatively, post-operatively 6 hours and 24 hours respectively.

• Length of hospital stay

  from the day of surgery to the day of discharge

• Postoperative complications

  up to 1 month post intervention

• Quality of Life (QoL)

  preoperatively and at 1 month postoperatively

Study Arms (2)

Patients in Group 1 undergo suction mini percutaneous nephrolithotomy

EXPERIMENTAL

Procedure: suction mini percutaneous nephrolithotomy

Patients in Group 2 undergo standard percutaneous nephrolithotomy

EXPERIMENTAL

Procedure: standard percutaneous nephrolithotomy

Interventions

standard percutaneous nephrolithotomy PROCEDURE

For standard PCNL, 24Fr sheath will be inserted, and 20Fr nephroscope (Richard Wolf, Germany) will be used. Renal stones will be fragmented and aspirated using an ultrasonic-lithotripter (LithoClast Master, EMS or ShockPluse-SE, Olympus).

Patients in Group 2 undergo standard percutaneous nephrolithotomy

suction mini percutaneous nephrolithotomy PROCEDURE

For suction mini-PCNL, 18Fr suction sheath (Wellead, China) will be inserted, and 12Fr mini-nephroscope will be used. Renal stones will be fragmented by pneumatic lithotriptor or Ho:YAG laser (1.0-2.0J ×20-30Hz), and stone fragments will be aspirated out via the suction sheath.

Patients in Group 1 undergo suction mini percutaneous nephrolithotomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-70 years.
• American Society of Anesthesiology (ASA) score of 1-2.
• Kidney stones measuring 2-4 cm in diameter on non-contrast computer tomography.
• Ability to provide written informed consent and adhere to trial requirements.

You may not qualify if:

• Anatomy abnormalities, such as urinary diversion, horseshoe kidney, transplanted kidney, or ureteropelvic junction obstruction.
• Untreated acute urinary tract infection (UTI).
• Patients on anticoagulant/antithrombotic therapy, or with uncorrected coagulopathies.
• Patients who decline trial enrolment or cannot adhere to trial requirements.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead
• Jose R. Reyes Memorial Medical Center, Manila, Philippines.: collaborator
• Zunyi Medical College: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• Renmin Hospital of Wuhan University: collaborator
• ZhuHai Hospital: collaborator
• Guizhou Provincial People's Hospital: collaborator
• Shufu People's Hospital, Kashgar Prefecture, Xinjiang Uygur Autonomous Region: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Chinese University of Hong Kong: collaborator
• Foshan Hospital of Traditional Chinese Medicine: collaborator
• Shenzhen University General Hospital: collaborator
• Hunan Provincial People' s Hospital: collaborator
• Huamei hospital, University of Chinese Academy of Sciences: collaborator
• Affliliated Hospital of Zunyi Medical University: collaborator
• The First People's Hospital of Fuquan City: collaborator
• Qiannan Buyi and Miao Autonomous Prefecture Hospital: collaborator
• Second Affiliated Hospital of Soochow University: collaborator
• University of Milan - Fondazione Ca'Granda IRCCS Ospedale Maggiore Policlinico Milano Italy: collaborator
• Sabah Al-Ahmad Urology Centre, Kuwait City, Kuwait: collaborator
• Military Medical Academy, Sofia, Bulgaria: collaborator
• Örebro University Hospital, Örebro, Sweden: collaborator
• University College London Hospitals: collaborator
• European Association of Urology Section of Endourology (ESEUT), Arnhem, The Netherlands: collaborator
• Central Hospital of Xiangtan: collaborator
• Cleveland Clinic, Ohio, USA: collaborator

Study Sites (1)

Department of Urology, Minimally invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510230, China

Location

Related Publications (3)

• 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: 32994063 RESULT

• Zhong 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: 32458093 RESULT

• Zhong W, Jiang K, Zhang X, Leung CH, Zhu W, Xu Z, Pang G, Sun Z, Cheng F, Li J, Chen J, Li Y, Yang H, Chen S, Wu C, Jia R, Zhu J, Gutierrez-Aceves J, Montanari E, Almousawi S, Saltirov I, Popiolek M, Aquino A, Mazzon G, Choong S, Xi H, Yuen SKK, Zeng G. Suction mini-percutaneous nephrolithotomy versus standard percutaneous nephrolithotomy for the management of 2-4 cm kidney stones: study protocol for an international, multicenter, parallel-group, noninferiority, randomized controlled trial. World J Urol. 2026 Feb 26;44(1):206. doi: 10.1007/s00345-026-06302-7.

  PMID: 41746369 DERIVED

MeSH Terms

Conditions

Kidney Calculi; Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Guohua Zeng, Ph.D & MD

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• 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: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

CN (1)