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NCT05088213
Suction Mini-PCNL Versus Standard PCNL for the Management of 2-4cm Kidney Stones
NA trial testing suction mini percutaneous nephrolithotomy in Kidney Calculi in 960 participants. Status unknown.
1 April 2023
Quick facts
| Lead sponsor | The First Affiliated Hospital of Guangzhou Medical University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 960 |
| Start date | 1 December 2021 |
| Primary completion | 1 April 2023 |
| Estimated completion | 1 December 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- suction mini percutaneous nephrolithotomy
- standard percutaneous nephrolithotomy
Conditions studied
- Kidney Calculi — all drugs for Kidney Calculi →
Sponsor
The First Affiliated Hospital of Guangzhou Medical University
Who can join
Adults 18 to 70, any sex, with Kidney Calculi. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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.
Zhong W, Jiang K, Zhang X, Leung CH, et al · · 2026 · PMID 41746369 · DOI 10.1007/s00345-026-06302-7
Verify or expand the search:
- PubMed search for NCT05088213
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05088213 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The First Affiliated Hospital of Guangzhou Medical University
- Last refreshed: 21 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05088213.
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