The Use of Direct Puncture Technique With Mini-PCNL

Urolithiasis Clinical Trial

Official title:

Single-center Randomized Study to Evaluate the Safety and Effectiveness of Direct Puncture of the Caliceal System in Minipercutaneous Nephrolithotripsy (Mini-PCNL)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04610840
• Other study ID #: 03/20-?
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: April 1, 2022

Study information

• Verified date: November 2021
• Source: St. Petersburg State Pavlov Medical University
• Contact: Dmitry S Gorelov
• Phone: +79217964892
• Email: dsgorelov[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Solitary stone up to 2.5 cm

4. Single access to the caliceal system

• Exclusion criteria:

1. Active infectious process

2. Coagulopathies

3. Abnormalities of the urinary system

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:

1. Gender

2. Age

3. Body mass index

4. Localization of the stone (side, pelvis, upper anterior cup, upper posterior cup, middle anterior cup, middle posterior cup, lower anterior cup, lower posterior cup)

5. Density of the stone

6. The presence of hydronephrosis

Indicators assessed during the operation - will be assessed by the physician-researcher:

1. Installation of the ureteral catheter

2. Duration of puncture

3. Puncture method (ultrasound, X-ray)

4. The success of the insertion of a flexible guidewire into the calyceal system

5. Problems during dilation of the puncture course

6. Visualization (Excellent, Moderate, Poor)

7. 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

1. Complications (Clavien)

2. Hemoglobin level 24 hours after surgery

3. Creatinine level 24 hours after surgery

4. Assessment of Stone-Free status after surgery by performing multislice computed tomography of the kidneys and urinary tract without intravenous contrast

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Active infectious process

• Coagulopathies

• Abnormalities of the urinary system

Related Conditions & MeSH terms

• Urinary Calculi
• Urolithiasis

Intervention

Procedure:
• Puncture of the caliceal system
Puncture of the caliceal system under ultrasound/Xray control

Locations

Country	Name	City	State
Russian Federation	First Pavlov Saint Petersburg University	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
St. Petersburg State Pavlov Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Puncture duration	Measurement of puncture duration (in seconds)	during the operation (mini-PCNL)
Primary	Number of patients with successful direct puncture	Evaluation of efficacy	during the operation (mini-PCNL)
Primary	Purity of a visual intraoperative field	Excellent, Moderate, Poor visualization	during the operation (mini-PCNL)
Primary	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	24 hours after operation