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

Not Applicable

• Conditions: Urolithiasis; Kidney Stone; Kidney Calculi; Ureteral Calculi; Kidney Diseases
• Interventions: Procedure: PCNL under fluoroscopic control; Procedure: PCNL under ultrasound control

• Registration Number: NCT04606758
• Lead Sponsor: Astana Medical University

Brief Summary

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 Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-27
• Last Update Submitted: 2020-10-27
• Study First Posted: 2020-10-28
• Last Update Posted: 2020-10-28
• Study Start: 2020-11
• Primary Completion: 2022-11
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCNL under fluoroscopic control	PCNL under fluoroscopic control	-
PCNL under ultrasound control	PCNL under ultrasound control	-

Primary Outcome Measures

Name	Time	Method
Blood loss as estimated by postoperative decreases in haemoglobin	Post-operative day 1

Secondary Outcome Measures

Name	Time	Method
Surgical outcomes	6 months	Outcome measures by using the clavien dindo classification system
Asses the easiness of accessibility of the targeted stone	Intraoperatively	Outcome measures by counting numbers of puncture trial
The Puncture fluoroscopy screening time	Intraoperatively	assessed on the monitor of C-Arm.