Renal Stone Treatment Global Registry

Official title

A Prospective Assessment of the Perioperative Parameter and Treatment Outcomes of Urinary Calculi - International Registry

Overview

This is an international prospective data registry to assess the treatment outcomes and complications of different treatment approaches for different surgical treatment of urolithiasis.

Detailed description

Renal stone is a common condition, and many patients suffered from recurrent diseases and required multiple interventions in their lifetime. Currently, there are many treatment options available for stone treatment, including shockwave lithotripsy, ureteroscopy, percutaneous nephrolithotomy etc.

Different treatment approaches will result in different treatment successful rate and also potential adverse effects to patients. The main challenge for stone management is the decision on the best treatment approach for individual stone of each patient. This is because for the same type of stone (such as lower caliceal stone or upper ureteric stone), different surgical treatment could be applied. The decision will depend on various patients (such as age, premorbid etc.) and stone factors (such as size, density etc) and also patients' preference.

New advances in technology have improved treatment outcomes for urolithiasis, such as single use flexible ureteroscopes, flexible and navigable ureteral access sheaths (FANS), direct in scope suction (DISS), intrarenal pressure (IRP) and intrarenal temperature (IRT) monitoring devices, new lasers and pulse modulation, etc.

Therefore, in order to have more information to guide treatment decision during discussion with patients, a prospective data registry is created to assess the treatment outcomes and complications of different treatment approaches in our hospital clusters. This information will be important for audit, treatment comparison and also patient education.

Primary outcome measures

• Target Stone status [Time frame: postoperative, at 1 and/or 3 months]

Secondary outcome measures (4)

• Intraoperative parameters [Time frame: intraoperative]
• Treatment related complication [Time frame: Thirty days after the operation]
• Recurrence of stone [Time frame: At 12 months]
• QOL and pain scores [Time frame: preoperative, postoperative on day 0 and at follow up]

Eligibility criteria

Inclusion criteria

• Patient at the age of 18 or above

Exclusion criteria

• Patient is unable to give consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Hong Kong · 3 centers

• Alice Ho Miu Ling Nethersole Hospital — Hong Kong
• Prince of Wales Hospital — Shatin
• North District Hospital — Sheung Shui

Publications

• Gauhar V, Traxer O, Fong KY, Sietz C, Chew BH, Bin Hamri S, Gokce MI, Gadzhiev N, Yuen SKK, Malkhasyan V, Ragoori D, Tanidir Y, Somani BK, Castellani D. Comparing Thulium Fiber Versus High-Power Holmium Laser Lithotripsy Combined with the Flexible and Navigable Suction Access Sheath in Flexible Ureteroscopy for Kidney Stone Disease: A Propensity Score Matched Analysis by the Global FANS Collaborat PMID 39676748
• Yuen SKK, Zhong W, Chan YS, Castellani D, Bhojani N, Agarwal MS, Tokas T, Croghan S, Jung H, Herrmann T, Somani B, Gauhar V; Global Research on Intra-renal Pressure Collaborative Group. Current utility, instruments, and future directions for intra-renal pressure management during ureteroscopy: scoping review by global research in intra-renal pressure collaborative group initiative. Ther Adv Urol. PMID 39896048
• Zhu W, Yuen SKK, Cao J, et al. Intrarenal pressure monitoring via flexible and navigable suction ureteral access sheath in retrograde intrarenal surgery: A preclinical animal study and a pilot clinical study. Clinical and Translational Discovery. 2025;5:e70031doi:10.1002/ctd2.70031
• Nedbal C, Yuen SKK, Akram M, Keller EX, Martinez BB, Philip J, Emiliani E, Li JKM, Stracci D, Gauhar V, Castellani D, Somani BK. First clinical evaluation of a flexible digital ureteroscope with direct in scope suctioning system (Pusen DISS 7.5Ch): prospective multicentric feasibility study. World J Urol. 2024 Oct 3;42(1):560. doi: 10.1007/s00345-024-05275-9. PMID 39361036
• Gauhar V, Traxer O, Castellani D, Sietz C, Chew BH, Fong KY, Hamri SB, Gokce MI, Gadzhiev N, Galosi AB, Yuen SKK, El Hajj A, Ko R, Zawadzki M, Sridharan V, Lakmichi MA, Corrales M, Malkhasyan V, Ragoori D, Soebhali B, Tan K, Chai CA, Tursunkulov AN, Tanidir Y, Persaud S, Elshazly M, Kamal W, Tefik T, Shrestha A, Tiong HC, Somani BK. Could Use of a Flexible and Navigable Suction Ureteral Access She PMID 38789313
• Yuen SKK, Traxer O, Wroclawski ML, Gadzhiev N, Chai CA, Lim EJ, Giulioni C, De Stefano V, Nedbal C, Maggi M, Sarica K, Castellani D, Somani B, Gauhar V. Scoping Review of Experimental and Clinical Evidence and Its Influence on Development of the Suction Ureteral Access Sheath. Diagnostics (Basel). 2024 May 16;14(10):1034. doi: 10.3390/diagnostics14101034. PMID 38786332
• Talyshinskii A, Tzelves L, Ventimiglia E, Yuen SKK, Gauhar V, Traxer O, Somani B. Technological innovation and revolution with single-use digital flexible ureteroscopes: a review from section of EAU Endourology. Curr Opin Urol. 2025 Jul 1;35(4):360-367. doi: 10.1097/MOU.0000000000001260. Epub 2025 Jan 7. PMID 39774241
• Gauhar V, Somani BK, Seitz C, Castellani D, Tefik T, Persaud S, Ragoori D, Gauhar V, Tan K, Lakmichi MA, Gadzhiev N, Malkhasyan V, Kamal W, Tanidir Y, Chai CA, Tursunkulov AN, Farahat Y, Keller EX, Chew BH, Herrmann T, Traxer O, Yuen SKK. A Global Survey to Assess Urologists' Attitudes Towards Suction Technology in Endourology by the European Association of Urology Section of Endourology and Progr PMID 39674378

Identifiers

NCT: NCT05297331 · CRE-2021.684

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗