Back to resultsFluoroscopic Guided vs US-guided Percutaneous Nephrolithotripsy for the Treatment of Stone Disease
Primary Purpose
Urolithiasis, Kidney Stone, Kidney Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PCNL under fluoroscopic control
PCNL under ultrasound control
Sponsored by
About this trial
This is an interventional treatment trial for Urolithiasis
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;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
PCNL under fluoroscopic control
PCNL under ultrasound control
Arm Description
Outcomes
Primary Outcome Measures
Blood loss as estimated by postoperative decreases in haemoglobin
Secondary Outcome Measures
Surgical outcomes
Outcome measures by using the clavien dindo classification system
Asses the easiness of accessibility of the targeted stone
Outcome measures by counting numbers of puncture trial
The Puncture fluoroscopy screening time
assessed on the monitor of C-Arm.
Full Information
NCT ID
NCT04606758
First Posted
October 15, 2020
Last Updated
October 27, 2020
Sponsor
Astana Medical University
Collaborators
Medipol University
1. Study Identification
Unique Protocol Identification Number
NCT04606758
Brief Title
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
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 2020 (Anticipated)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astana Medical University
Collaborators
Medipol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis, Kidney Stone, Kidney Diseases, Ureteral Calculi, Kidney Calculi
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PCNL under fluoroscopic control
Arm Type
Active Comparator
Arm Title
PCNL under ultrasound control
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
PCNL under fluoroscopic control
Intervention Description
Patients receive standard of care treatment for their urolithiasis using standard PCNL under fluoroscopic guidance
Intervention Type
Procedure
Intervention Name(s)
PCNL under ultrasound control
Intervention Description
Patients receive standard of care treatment for their urolithiasis using standard PCNL under US guidance
Primary Outcome Measure Information:
Title
Blood loss as estimated by postoperative decreases in haemoglobin
Time Frame
Post-operative day 1
Secondary Outcome Measure Information:
Title
Surgical outcomes
Description
Outcome measures by using the clavien dindo classification system
Time Frame
6 months
Title
Asses the easiness of accessibility of the targeted stone
Description
Outcome measures by counting numbers of puncture trial
Time Frame
Intraoperatively
Title
The Puncture fluoroscopy screening time
Description
assessed on the monitor of C-Arm.
Time Frame
Intraoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ulanbek Zhanbyrbekuly
Phone
+77071652019
Email
ulanbek.amu@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Fluoroscopic Guided vs US-guided Percutaneous Nephrolithotripsy for the Treatment of Stone Disease
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