Renal Stone Treatment Global Registry

March 26, 2025 updated by: Chi Fai NG, Chinese University of Hong Kong

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

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

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Alice Ho Miu Ling Nethersole Hospital
        • Contact:
      • Shatin, Hong Kong
      • Sheung Shui, Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with urinary stones and planned for surgery (including shockwave lithotripsy, ureteroscopy, percutaneous nephrolithotomy (PCNL), laparoscopic ureterolithiasis, open stone procedures etc) in the hospitals will be identified and then enrolled to the study.

Description

Inclusion Criteria:

  • Patient at the age of 18 or above

Exclusion Criteria:

  • Patient is unable to give consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
FLEXOR-FANS (flexible and navigable suction ureteral access sheath)
Cohort of flexible ureteroscopy with flexible and navigable suction ureteral access sheath (fURS FANS) will be studied
DISS (Direct in scope suction)
Cohort of flexible ureteroscopy with direct in scope suction (DISS) will be studied
Flexible ureteroscopy - IRP / IRT
Cohort of flexible ureteroscopy with and without real-time intrarenal pressure (IRP) monitoring and/or intrarenal temperature (IRT) will be studied
Shockwave lithotripsy (SWL)
Cohort of extracorporeal shockwave lithotripsy (SWL) will be studied
Percutaneous nephrolithotomy (PCNL)
Cohort of percutaneous nephrolithotomy with or without intrarenal pressure and temperature monitoring will be studied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Stone status
Time Frame: postoperative, at 1 and/or 3 months
stone free rate
postoperative, at 1 and/or 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment related complication
Time Frame: Thirty days after the operation
The 30-day complications will be graded according to the Clavien-Dindo classification
Thirty days after the operation
Intraoperative parameters
Time Frame: intraoperative
Including irrigation and suction and laser settings and devices, laser consumption and efficacy, fluoroscopy dosage and time, equipment (ureteral access sheath size and lengths, ureteroscopy sizes, stone basket) utilised; exit strategy; intraoperative complications if noted; ergonomics
intraoperative
Recurrence of stone
Time Frame: At 12 months
Stone recurrence rate
At 12 months
QOL and pain scores
Time Frame: preoperative, postoperative on day 0 and at follow up
Pain VAS scores and QOL assessment
preoperative, postoperative on day 0 and at follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Chi Fai NG, MD, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Estimated)

December 31, 2032

Study Completion (Estimated)

March 31, 2033

Study Registration Dates

First Submitted

March 9, 2022

First Submitted That Met QC Criteria

March 22, 2022

First Posted (Actual)

March 28, 2022

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 26, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2021.684

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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