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

NCT04606758 | Unknown

• 1 other identifier: 8
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Urolithiasis; Kidney Stone; Kidney Diseases; Ureteral Calculi; Kidney Calculi

Outcome Measures

Primary Outcomes (1)

• Blood loss as estimated by postoperative decreases in haemoglobin

  Post-operative day 1

Secondary Outcomes (3)

• Surgical outcomes

  6 months

• Asses the easiness of accessibility of the targeted stone

  Intraoperatively

• The Puncture fluoroscopy screening time

  Intraoperatively

Study Arms (2)

PCNL under fluoroscopic control

ACTIVE COMPARATOR

Procedure: PCNL under fluoroscopic control

PCNL under ultrasound control

ACTIVE COMPARATOR

Procedure: PCNL under ultrasound control

Interventions

PCNL under fluoroscopic control PROCEDURE

Patients receive standard of care treatment for their urolithiasis using standard PCNL under fluoroscopic guidance

PCNL under fluoroscopic control

PCNL under ultrasound control PROCEDURE

Patients receive standard of care treatment for their urolithiasis using standard PCNL under US guidance

PCNL under ultrasound control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Astana Medical University: lead
• Medipol University: collaborator

MeSH Terms

Conditions

Urolithiasis; Kidney Calculi; Kidney Diseases; Ureteral Calculi

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephrolithiasis; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Ureterolithiasis; Ureteral Diseases

Central Study Contacts

Ulanbek Zhanbyrbekuly

CONTACT

+77071652019; ulanbek.amu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 28, 2020
• Study Start: November 1, 2020
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 28, 2020

Record last verified: 2020-10