UrolithiasisNCT04606758
Fluoroscopic Guided vs US-guided Percutaneous Nephrolithotripsy for the Treatment of Stone Disease
A study of Urolithiasis and Kidney Stone, run by Astana Medical University.
Trial summary
Randomized comparison of patient outcomes following fluoroscopic guided PCNL versus ultrasound-guided PCNL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis, Kidney Stone, Kidney Diseases
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Nov 2020to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients planned for PCNL at participating institution
- Patients of all ethnic backgrounds
- Stone size over 10 mm in diameter and a density over 900 Hounsfield units
- Patients with a large calculus in the upper third of the ureter
Who cannot join
- Pregnancy
- infectious disease of the genitals;
- conditions that violate the configuration of the kidneys (curvature of the spinal column)
- anomalies in the development of the kidneys with impaired configuration and position of the kidneys (horseshoe kidney, bisque kidney, S-shaped kidney, L-shaped kidney, lumbar dystopia, iliac dystopia, pelvic dystopia)
- presence of nephrostomy drainage in the target kidney;
- urethral stricture or other reason leading to the inability to carry out ureteral catheterization;
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- other conditions that are contraindications to surgical treatment, such as uncontrolled diabetes mellitus, acute cardiovascular conditions, liver failure, alcoholism, and drug addiction;
- patients who are unable to understand the purpose of the study or refuse further follow-up observation and instructions after treatment;
- patients with a history of mental illness;
- participation in another research that interferes with this research;
- acute renal failure;
- dissecting aortic aneurysm;
- acute hypertensive encephalopathy;
- heavy arterial bleeding;
- myocardial infarction less than six months before enrollment in the study;
- Stroke less than six months before enrollment in the study;
- Insufficiency of blood circulation III-IV New York Heart Association class;
- Severe rhythm and conduction disturbances;
- Increase in the level of liver transaminases by more than three times;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized Controlled Trial Comparing Surgical Outcomes Following PCNL Under Ultrasound Control and PCNL Under Fluoroscopic Control in the Treatment of Kidney Stones
Randomized comparison of patient outcomes following fluoroscopic guided PCNL versus ultrasound-guided PCNL.
Read the detailed description
This study is a randomized controlled trial that compares the operative outcomes and complications of fluoroscopic guided-percutaneous nephrolithotomy versus ultrasound-guided PCNL for renal stones. This study will be a prospective randomized controlled clinical trial with patients who have already agreed to undergo PCNL. Patients will be randomized at a 1:1 ratio to receive either PCNL under fluoroscopic guidance or PCNL under ultrasound guidance. Patients will be asked to complete pre-operative, and postoperative quality of life questionnaires, and to allow the collection of one additional vial of blood for measurement of factors associated with inflammation.
- Conditions
- Urolithiasis, Kidney Stone, Kidney Diseases, Ureteral Calculi, Kidney Calculi
- Being tested
- PCNL under fluoroscopic control, PCNL under ultrasound control
- Medical subject headings
- Urolithiasis, Kidney Calculi, Kidney Diseases, Ureteral Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCNL under fluoroscopic controlProcedure or surgery
Patients receive standard of care treatment for their urolithiasis using standard PCNL under fluoroscopic guidance
PCNL under ultrasound controlProcedure or surgery
Patients receive standard of care treatment for their urolithiasis using standard PCNL under US guidance
| Study group | Role | What they receive |
|---|---|---|
| PCNL under fluoroscopic control | Active comparator | Not described Receives: Procedure: PCNL under fluoroscopic control |
| PCNL under ultrasound control | Active comparator | Not described Receives: Procedure: PCNL under ultrasound control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss as estimated by postoperative decreases in haemoglobin
Measured: Post-operative day 1
Secondary outcomes (3)
Surgical outcomes
Outcome measures by using the clavien dindo classification system
Measured: 6 months
Asses the easiness of accessibility of the targeted stone
Outcome measures by counting numbers of puncture trial
Measured: Intraoperatively
The Puncture fluoroscopy screening time
assessed on the monitor of C-Arm.
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study startNov 2020 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Astana Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Medipol University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606758
- Sponsor's protocol ID
- 8
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Surgical Outcomes Following PCNL Under Ultrasound Control and PCNL Under Fluoroscopic Control in the Treatment of Kidney Stones
- ClinicalTrials.gov ID
- NCT04606758
- Acronym / sponsor ID
- 8
- Conditions
- Urolithiasis, Kidney Stone, Kidney Diseases, Ureteral Calculi, Kidney Calculi
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Astana Medical UniversityUniversity, hospital or other
- Collaborators
- Medipol University
- Study start
- Nov 2020 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized comparison of patient outcomes following fluoroscopic guided PCNL versus ultrasound-guided PCNL.
Detailed description
This study is a randomized controlled trial that compares the operative outcomes and complications of fluoroscopic guided-percutaneous nephrolithotomy versus ultrasound-guided PCNL for renal stones. This study will be a prospective randomized controlled clinical trial with patients who have already agreed to undergo PCNL. Patients will be randomized at a 1:1 ratio to receive either PCNL under fluoroscopic guidance or PCNL under ultrasound guidance. Patients will be asked to complete pre-operative, and postoperative quality of life questionnaires, and to allow the collection of one additional vial of blood for measurement of factors associated with inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCNL under fluoroscopic control | Active comparator | Procedure: PCNL under fluoroscopic control |
| PCNL under ultrasound control | Active comparator | Procedure: PCNL under ultrasound control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients planned for PCNL at participating institution
- Patients of all ethnic backgrounds
- Stone size over 10 mm in diameter and a density over 900 Hounsfield units
- Patients with a large calculus in the upper third of the ureter
Key exclusion criteria (19 listed)
- Pregnancy
- infectious disease of the genitals;
- conditions that violate the configuration of the kidneys (curvature of the spinal column)
- anomalies in the development of the kidneys with impaired configuration and position of the kidneys (horseshoe kidney, bisque kidney, S-shaped kidney, L-shaped kidney, lumbar dystopia, iliac dystopia, pelvic dystopia)
- presence of nephrostomy drainage in the target kidney;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCNL under fluoroscopic controlPatients receive standard of care treatment for their urolithiasis using standard PCNL under fluoroscopic guidance | Procedure or surgery | PCNL under fluoroscopic control |
| PCNL under ultrasound controlPatients receive standard of care treatment for their urolithiasis using standard PCNL under US guidance | Procedure or surgery | PCNL under ultrasound control |
Primary outcome
Blood loss as estimated by postoperative decreases in haemoglobin
Time frame: Post-operative day 1
3 secondary outcomes
Surgical outcomes
Time frame: 6 months
Asses the easiness of accessibility of the targeted stone
Time frame: Intraoperatively
The Puncture fluoroscopy screening time
Time frame: Intraoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study of Urolithiasis and Kidney Stone, run by Astana Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ulanbek Zhanbyrbekuly (+77071652019, ulanbek.amu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood loss as estimated by postoperative decreases in haemoglobin (time frame: Post-operative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.