UrolithiasisNCT04610840
The Use of Direct Puncture Technique With Mini-PCNL
A study testing Puncture of the caliceal system in people with Urolithiasis, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
Trial summary
A single-center randomized study to evaluate the safety and effectiveness of direct puncture of the caliceal system in mini-percutaneous nephrolithotripsy. 60 patients Inclusion criteria: 1. all patients aged 18 to 70 years who are planning mini-PCNL, ready to consent to the study 2. ASA scale 1-3 3. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Urolithiasis
- What is being tested?
- Puncture of the caliceal system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jul 2020to 1 Apr 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 70 years who are scheduled for mini-PCNL, ready to consent to the study
- ASA scale 1-3
- Solitary kidney stone up to 2.5 cm
- One access to the caliceal system
Who cannot join
- Active infectious process
- Coagulopathies
- Abnormalities of the urinary system
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
First Pavlov Saint Petersburg University
Saint Petersburg, 197342
Dmitriy Gorelov, MD, +79217964892, dsgorelov@mail.ru
About this study
Official title: Single-center Randomized Study to Evaluate the Safety and Effectiveness of Direct Puncture of the Caliceal System in Minipercutaneous Nephrolithotripsy (Mini-PCNL)
- A single-center randomized study to evaluate the safety and effectiveness of direct puncture of the caliceal system in mini-percutaneous nephrolithotripsy.
- 60 patients
- Inclusion criteria:
- all patients aged 18 to 70 years who are planning mini-PCNL, ready to consent to the study
- ASA scale 1-3
- Solitary stone up to 2.5 cm
- Single access to the caliceal system
- Exclusion criteria:
- Active infectious process
- Coagulopathies
- Abnormalities of the urinary system
Read the detailed description
All patients will be randomized into 2 groups:
Direct puncture - patients who underwent directive puncture under ultrasound or Rg control. The number of patients is 30 people.
Non-direct puncture - patients who underwent a PCS puncture with retrograde contrast. The number of patients is 30 people.
Patients will be assigned a randomization number that matches their treatment. Block randomization using 10 blocks will be performed by a central randomization organization (www.randomize.net) using a computerized algorithm.
Primary assessed indicators:
- Gender
- Age
- Body mass index
- Localization of the stone (side, pelvis, upper anterior cup, upper posterior cup, middle anterior cup, middle posterior cup, lower anterior cup, lower posterior cup)
- Density of the stone
- The presence of hydronephrosis
Indicators assessed during the operation - will be assessed by the physician-researcher:
- Installation of the ureteral catheter
- Duration of puncture
- Puncture method (ultrasound, X-ray)
- The success of the insertion of a flexible guidewire into the calyceal system
- Problems during dilation of the puncture course
- Visualization (Excellent, Moderate, Poor)
- Type of drainage (stent, nephrostomic tube) at the end of the operation Using the Visual Analogue Pain Scale (VAS), pain assessment is planned at 2 hours, 6 hours, 12 hours and 24 hours after surgery.
In the postoperative period, the patient independently controls the intake of analgesics from the NSAID group (ketorolac 100 mg) (Patient-controlled analgesia). If the patient requires analgesics, the time of taking the drug will be recorded (pain relief on demand).
Secondary Assessment: Postoperative Assessment
- Complications (Clavien)
- Hemoglobin level 24 hours after surgery
- Creatinine level 24 hours after surgery
- Assessment of Stone-Free status after surgery by performing multislice computed tomography of the kidneys and urinary tract without intravenous contrast
- Conditions
- Urolithiasis
- Being tested
- Puncture of the caliceal system
- Keywords
- urolithiasis, PCNL, direct puncture
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Puncture of the caliceal systemProcedure or surgery
Puncture of the caliceal system under ultrasound/Xray control
| Study group | Role | What they receive |
|---|---|---|
| Direct puncture | Active comparator | Direct puncture of the caliceal system performed under ultrasound or Xray control Receives: Procedure: Puncture of the caliceal system |
| Non-direct puncture | Active comparator | Puncture of the caliceal system performed under ultrasound or Xray control and retrograde contrast Receives: Procedure: Puncture of the caliceal system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Puncture duration
Measurement of puncture duration (in seconds)
Measured: during the operation (mini-PCNL)
Number of patients with successful direct puncture
Evaluation of efficacy
Measured: during the operation (mini-PCNL)
Purity of a visual intraoperative field
Excellent, Moderate, Poor visualization
Measured: during the operation (mini-PCNL)
Body pain
Using the Visual Analogue Pain Scale (VAS), pain assessment is planned at 2 hours, 6 hours, 12 hours and 24 hours after surgery
Measured: 24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start1 Jul 2020
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Apr 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
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610840
- Sponsor's protocol ID
- 03/20-н
- Status last verified
- Nov 2021
- First submitted
- 5 Aug 2020
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Randomized Study to Evaluate the Safety and Effectiveness of Direct Puncture of the Caliceal System in Minipercutaneous Nephrolithotripsy (Mini-PCNL)
- ClinicalTrials.gov ID
- NCT04610840
- Acronym / sponsor ID
- 03/20-н
- Conditions
- Urolithiasis
- Keywords
- urolithiasis, PCNL, direct puncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- St. Petersburg State Pavlov Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 2 Nov 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.
- A single-center randomized study to evaluate the safety and effectiveness of direct puncture of the caliceal system in mini-percutaneous nephrolithotripsy.
- 60 patients
- Inclusion criteria:
- all patients aged 18 to 70 years who are planning mini-PCNL, ready to consent to the study
- ASA scale 1-3
- Solitary stone up to 2.5 cm
- Single access to the caliceal system
- Exclusion criteria:
- Active infectious process
- Coagulopathies
- Abnormalities of the urinary system
Detailed description
All patients will be randomized into 2 groups:
Direct puncture - patients who underwent directive puncture under ultrasound or Rg control. The number of patients is 30 people.
Non-direct puncture - patients who underwent a PCS puncture with retrograde contrast. The number of patients is 30 people.
Patients will be assigned a randomization number that matches their treatment. Block randomization using 10 blocks will be performed by a central randomization organization (www.randomize.net) using a computerized algorithm.
Primary assessed indicators:
- Gender
- Age
- Body mass index
- Localization of the stone (side, pelvis, upper anterior cup, upper posterior cup, middle anterior cup, middle posterior cup, lower anterior cup, lower posterior cup)
- Density of the stone
- The presence of hydronephrosis
Indicators assessed during the operation - will be assessed by the physician-researcher:
- Installation of the ureteral catheter
- Duration of puncture
- Puncture method (ultrasound, X-ray)
- The success of the insertion of a flexible guidewire into the calyceal system
- Problems during dilation of the puncture course
- Visualization (Excellent, Moderate, Poor)
- Type of drainage (stent, nephrostomic tube) at the end of the operation Using the Visual Analogue Pain Scale (VAS), pain assessment is planned at 2 hours, 6 hours, 12 hours and 24 hours after surgery.
In the postoperative period, the patient independently controls the intake of analgesics from the NSAID group (ketorolac 100 mg) (Patient-controlled analgesia). If the patient requires analgesics, the time of taking the drug will be recorded (pain relief on demand).
Secondary Assessment: Postoperative Assessment
- Complications (Clavien)
- Hemoglobin level 24 hours after surgery
- Creatinine level 24 hours after surgery
- Assessment of Stone-Free status after surgery by performing multislice computed tomography of the kidneys and urinary tract without intravenous contrast
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct puncture | Active comparator | Procedure: Puncture of the caliceal systemDirect puncture of the caliceal system performed under ultrasound or Xray control |
| Non-direct puncture | Active comparator | Procedure: Puncture of the caliceal systemPuncture of the caliceal system performed under ultrasound or Xray control and retrograde contrast |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 to 70 years who are scheduled for mini-PCNL, ready to consent to the study
- ASA scale 1-3
- Solitary kidney stone up to 2.5 cm
- One access to the caliceal system
Key exclusion criteria (3 listed)
- Active infectious process
- Coagulopathies
- Abnormalities of the urinary system
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 |
|---|---|---|
| Puncture of the caliceal systemPuncture of the caliceal system under ultrasound/Xray control | Procedure or surgery | Direct puncture, Non-direct puncture |
Primary outcome
Puncture duration
Time frame: during the operation (mini-PCNL)
Measurement of puncture duration (in seconds)
Number of patients with successful direct puncture
Time frame: during the operation (mini-PCNL)
Evaluation of efficacy
Purity of a visual intraoperative field
Time frame: during the operation (mini-PCNL)
Excellent, Moderate, Poor visualization
Body pain
Time frame: 24 hours after operation
Using the Visual Analogue Pain Scale (VAS), pain assessment is planned at 2 hours, 6 hours, 12 hours and 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Puncture of the caliceal system in people with Urolithiasis, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
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 3 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 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Dmitry S Gorelov (+79217964892, dsgorelov@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Puncture duration (time frame: during the operation (mini-PCNL)). The study lists 4 primary outcomes in all. 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 9 Nov 2021.