Fluoroscopic Guided vs US-guided Percutaneous Nephrolithotripsy for the Treatment of Stone Disease

Kidney Diseases Clinical Trial

Official title:

Randomized Controlled Trial Comparing Surgical Outcomes Following PCNL Under Ultrasound Control and PCNL Under Fluoroscopic Control in the Treatment of Kidney Stones

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04606758
• Other study ID #: 8
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2020
• Est. completion date: December 2022

Study information

• Verified date: October 2020
• Source: Astana Medical University
• Contact: Ulanbek Zhanbyrbekuly
• Phone: +77071652019
• Email: ulanbek.amu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized comparison of patient outcomes following fluoroscopic guided PCNL versus ultrasound-guided PCNL.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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;
• 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;

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Kidney Diseases
• Kidney Stone
• Nephrolithiasis
• Ureteral Calculi
• Ureterolithiasis
• Urolithiasis

Intervention

Procedure:
• PCNL under fluoroscopic control
Patients receive standard of care treatment for their urolithiasis using standard PCNL under fluoroscopic guidance
• PCNL under ultrasound control
Patients receive standard of care treatment for their urolithiasis using standard PCNL under US guidance

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astana Medical University	Medipol University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss as estimated by postoperative decreases in haemoglobin		Post-operative day 1
Secondary	Surgical outcomes	Outcome measures by using the clavien dindo classification system	6 months
Secondary	Asses the easiness of accessibility of the targeted stone	Outcome measures by counting numbers of puncture trial	Intraoperatively
Secondary	The Puncture fluoroscopy screening time	assessed on the monitor of C-Arm.	Intraoperatively