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

Sponsor
Astana Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04606758
Collaborator
Medipol University (Other)
150
2
25

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: PCNL under fluoroscopic control
  • Procedure: PCNL under ultrasound control
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Randomized Controlled Trial Comparing Surgical Outcomes Following PCNL Under Ultrasound Control and PCNL Under Fluoroscopic Control in the Treatment of Kidney Stones
Anticipated Study Start Date :
Nov 1, 2020
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Blood loss as estimated by postoperative decreases in haemoglobin [Post-operative day 1]

Secondary Outcome Measures

  1. Surgical outcomes [6 months]

    Outcome measures by using the clavien dindo classification system

  2. Asses the easiness of accessibility of the targeted stone [Intraoperatively]

    Outcome measures by counting numbers of puncture trial

  3. The Puncture fluoroscopy screening time [Intraoperatively]

    assessed on the monitor of C-Arm.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Astana Medical University
  • Medipol University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Astana Medical University
ClinicalTrials.gov Identifier:
NCT04606758
Other Study ID Numbers:
  • 8
First Posted:
Oct 28, 2020
Last Update Posted:
Oct 28, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 28, 2020