The Use of Direct Puncture Technique With Mini-PCNL

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:

  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

Study Overview

• Status: Recruiting
• Conditions: Urolithiasis
• Intervention / Treatment: Procedure: Puncture of the caliceal 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:

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dmitry S Gorelov; Phone Number: +79217964892; Email: dsgorelov@mail.ru
• Study Contact Backup: Name: Vladimir M Obidniak; Phone Number: +79218944746; Email: v.obidniak@gmail.com

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation, 197342
    • Recruiting
    • First Pavlov Saint Petersburg University
    • Contact: Dmitriy Gorelov, MD; Phone Number: +79217964892; Email: dsgorelov@mail.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Direct puncture; Direct puncture of the caliceal system performed under ultrasound or Xray control	Procedure: Puncture of the caliceal system; Puncture of the caliceal system under ultrasound/Xray control
ACTIVE_COMPARATOR: Non-direct puncture; Puncture of the caliceal system performed under ultrasound or Xray control and retrograde contrast	Procedure: Puncture of the caliceal system; Puncture of the caliceal system under ultrasound/Xray control

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: St. Petersburg State Pavlov Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2020
• Primary Completion (ANTICIPATED): February 1, 2022
• Study Completion (ANTICIPATED): April 1, 2022

Study Registration Dates

• First Submitted: August 5, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (ACTUAL): November 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 8, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: urolithiasis; PCNL; direct puncture
• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Calculi; Urinary Calculi; Urolithiasis
• Other Study ID Numbers: 03/20-н

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