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

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

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

Study Overview

• Status: Unknown
• Conditions: Kidney Diseases; Kidney Calculi; Urolithiasis; Ureteral Calculi; Kidney Stone
• Intervention / Treatment: Procedure: PCNL under fluoroscopic control; Procedure: PCNL under ultrasound control

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PCNL under fluoroscopic control	Procedure: PCNL under fluoroscopic control; Patients receive standard of care treatment for their urolithiasis using standard PCNL under fluoroscopic guidance
Active Comparator: PCNL under ultrasound control	Procedure: PCNL under ultrasound control; Patients receive standard of care treatment for their urolithiasis using standard PCNL under US guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood loss as estimated by postoperative decreases in haemoglobin	Post-operative day 1

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Astana Medical University
• Collaborators: Medipol University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2020
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): October 28, 2020

Study Record Updates

• Last Update Posted (Actual): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Ureteral Diseases; Urinary Calculi; Kidney Diseases; Urolithiasis; Calculi; Kidney Calculi; Nephrolithiasis; Ureteral Calculi; Ureterolithiasis
• Other Study ID Numbers: 8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No