RIRS With Tip Flexible Pressure-controlling Ureteral Access Sheath Versus Mini PCNLfor Kidney Stones

January 14, 2024 updated by: Huang Xin, The Affiliated Ganzhou Hospital of Nanchang University

Retrograde Intrarenal Surgery With Tip Flexible Pressure-controlling Ureteral Access Sheath Versus Mini Percutaneous Nephrolithotomy for the Treatment of 2-3-cm Kidney Stones

The goal of this observational study is to compare the safety and efficacy between RIRS with tip flexible pressure-controlling ureteral access sheath and mini percutaneous nephrolithotripsy（PCNL） for the treatment of 2-3-cm kidney stones.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Retrograde Intrarenal Stone Surgery (RIRS) has become one of the most common treatments for renal stones. The development of ureteral access sheath (UAS) is a significant advance in RIRS. In recent years, various improvements have been made to UAS, especially the emergence of a suction UAS and a tip flexible UAS. Using the advantages of suction and tip flexible technology, our team developed a tip flexible pressure-controlling UAS, which significantly improves the safety and effectiveness of RIRS. However, the current guidelines can recommend the indication of RIRS in kidney stones less than 2cm, and percutaneous nephrolithotomy(PCNL) is still preferred for kidney stones larger than 2 cm. Therefore, this study is the first to compare the safety and efficacy between RIRS with tip flexible pressure-controlling UAS and mini PCNL in the treatment of 2 to 3 cm kidney stones.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jiangxi
      • Ganzhou, Jiangxi, China, 341000
        • Recruiting
        • Xiaolin Deng
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Kidney stones were confirmed in all patients by imaging, including urinary tract ultrasonography, intravenous urography, and computed tomography (CT). Stone size was calculated by CT scans.

Description

Inclusion Criteria:

  • Adults aged ≥ 18 years
  • American Society of Anesthesiology score 1-2
  • Kidney stone diameter of 2-3 cm confirmed by CT
  • Capable of giving written informed consent, which includes adherence with the requirements of the trial

Exclusion Criteria:

  • Patients with abnormal urinary tract anatomy (such as horseshoe kidney or ileal conduit)
  • Patients with uncontrolled UTI
  • Patients with health or other factors that are absolute contraindications to RIRS or PCNL .Patients unable to understand or complete trial documentation.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
RIRS
Patients were performed under general anesthesia in the oblique supine lithotomy position. Initially, preliminary ureteroscopy was performed with a semirigid 8/9.8 Fr ureteroscope guided by zebra guide wire. Next, the patented tip flexible pressure-controlling ureteral access sheath (UAS,12/14 Fr) was inserted along the guidewire without the fluoroscopic guidance. The fully automatic mode was chosen to operate the platform.The pressure sensory and suctioning channels of UAS were connected to the irrigation and suctioning platform. After water injection, zero calibration was performed at platform. Perfusion flow rate was then set at 100-150 ml/min, the renal pelvic pressure (RPP) control value was set at -15~5 mmHg, the RPP warning value was set at 20 mmHg, and the RPP maximum value was set at 30 mmHg. Intraoperatively, a holmium laser was used to crush the stone at 1.5-2.0 J/pulse with a frequency of 20-30 pulses/s ( (CHUNHUI, CHINA, 276µm).
Procedure: RIRS
RIRS with tip flexible pressure-controlling ureteral access sheath versus mini PCNL for the treatment of 2-3-cm kidney stones
Other Names:
  • MPCNL
MPCNL
Patients were performed under general anesthesia. The patient was first placed in a lithotomy position. A 5 Fr ureteral catheter was then inserted retrogradely into the renal pelvis through cystoscopy or ureteroscopy , and saline was continuously infused to produce artificial hydronephrosis. The patient was then placed in the prone position. Ultrasound-guided percutaneous punctures were made with an 18-gauge coaxial needle into the targeted calix. The puncture point was in the 12th rib infracostal margin, between the posterior axillary line and scapula line. A Zebra guidewire was inserted and fixed. The puncture needle was then removed. After a 0.5-0.7 cm skin incision was made, the percutaneous tract was dilated serially over the guidewire with a fascial dilator to 18Fr. Holmium laser lithotripsy at 1.5-2.0 J/pulse with a frequency of 20-30 pulses/s (CHUNHUI, CHINA, 550µm) was performed with a 18 Fr peel-away sheath.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Immediate stone-free rate
Time Frame: Postoperative day 1-7
No residual stone or stone fragments less than 2 mm on low-dose CT scan at postoperative day 1-7 are defined as stone free.
Postoperative day 1-7
Stone-free rate at 1 months
Time Frame: Postoperative 1 month
No residual stone or stone fragments less than 2 mm on kidney, ureter, and bladder at 1 months are defined as stone free.
Postoperative 1 month
Complications up to 3 months post
Time Frame: Postoperative 3 month
Postoperative 3 month
Operation time
Time Frame: the time from the insertion of the suction sheath and renal puncture to the end of the operation,assessed up to 90 minutes.
The operation time of RIRS and mini PCNL was defined as the time from the insertion of the suction sheath and renal puncture to the end of the operation
the time from the insertion of the suction sheath and renal puncture to the end of the operation,assessed up to 90 minutes.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Affiliated Ganzhou Hospital of Nanchang University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Leming Song, The Affiliated Ganzhou Hospital of Nanchang University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TY-ZKY-2023-045-12

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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