Clinical trial NCT04606758: Fluoroscopic Guided vs US-guided Percutaneous Nephrolithotripsy for the Treatment of Stone Disease
Official title: Randomized Controlled Trial Comparing Surgical Outcomes Following PCNL Under Ultrasound Control and PCNL Under Fluoroscopic Control in the Treatment of Kidney Stones
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urolithiasis
Kidney Stone
Kidney Diseases
Ureteral Calculi
Kidney Calculi
Lead sponsor: Astana Medical University
Sponsor class: OTHER
Collaborators: name: Medipol University
First posted: 2020-10-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Blood loss as estimated by postoperative decreases in haemoglobin
timeFrame: Post-operative day 1
Secondary outcomes:
measure: Surgical outcomes
timeFrame: 6 months
measure: Asses the easiness of accessibility of the targeted stone
timeFrame: Intraoperatively
measure: The Puncture fluoroscopy screening time
timeFrame: Intraoperatively
Other outcomes:
Locations:
Study officials:
References: