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

NCT ID: NCT04606758

Last Updated: 2020-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-30

Study Completion Date

2022-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Urolithiasis Kidney Stone Kidney Diseases Ureteral Calculi Kidney Calculi

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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PCNL under fluoroscopic control

Group Type ACTIVE_COMPARATOR

PCNL under fluoroscopic control

Intervention Type PROCEDURE

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

PCNL under ultrasound control

Group Type ACTIVE_COMPARATOR

PCNL under ultrasound control

Intervention Type PROCEDURE

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

Interventions

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PCNL under fluoroscopic control

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

Intervention Type PROCEDURE

PCNL under ultrasound control

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

Intervention Type PROCEDURE

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medipol University

OTHER

Sponsor Role collaborator

Astana Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Ulanbek Zhanbyrbekuly

Role: CONTACT

[email protected]
+77071652019

Other Identifiers

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8

Identifier Type: -

Identifier Source: org_study_id