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Clinical Outcomes of Percutaneous Nephrolithotomy Following Retrograde Percutaneous Nephrostomy Access Using Novel Device in Comparison to Antegrade Access

Primary Purpose

Kidney Stone

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
retrograde nephrostomy
antegrade nephrostomy
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Stone focused on measuring nephrostomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-Renal pelvis and proximal ureteral stones >10 mm confirmed with non-contrast computed tomography

Exclusion Criteria:

  • Suspected pyelonephritis.
  • Prior percutaneous nephrolithotomy procedure in affected kidney.
  • Mid-ureteral or distal ureteral stones.
  • Pregnancy.

  • Anatomical abnormal kidney, including:

    • Horseshoe
    • Ectopic

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment (retrograde nephrostomy)

Control Group ( antegrade nephrostomy)

Arm Description

Outcomes

Primary Outcome Measures

Treatment efficacy as measured by the time taken from diagnosis to nephrostomy access
Treatment efficacy as measured by total time of access operation.
Treatment efficacy as measured by total time of access operation fluoroscopy
Treatment efficacy as measured by total time of lithotomy operation
Treatment efficacy as measured by total time of lithotomy operation fluoroscopy
Treatment efficacy as measured by length of post-operative hospital stay
Number of patients that are stone free
stone free is defined as <2mm on non-contrast computed tomography
Number of patients with symptom free survival as defined as lack of flank pain
Number of patients with symptom free survival as defined as lack of presence of urinary or gastrointestinal symptoms,
Number of patients with symptom free survival as defined as lack of limitations to work
Number of patients with symptom free survival as defined as lack of limitations to social or daily activities.

Secondary Outcome Measures

Number of patients with nephrostomy access adequate for stone treatment
Number of patients with normal vital signs
Number of patients with normal laboratory values
laboratory values include complete metabolic panel and urinalysis
Number of patients with an infection rate which is defined as a positive culture within the study time period
Number of patients that require pain medication (defined as discharge with an opioid prescription).

Full Information

First Posted
August 19, 2021
Last Updated
May 9, 2023
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT05022537
Brief Title
Clinical Outcomes of Percutaneous Nephrolithotomy Following Retrograde Percutaneous Nephrostomy Access Using Novel Device in Comparison to Antegrade Access
Official Title
Clinical Outcomes of Percutaneous Nephrolithotomy Following Retrograde Percutaneous Nephrostomy Access Using Novel Device in Comparison to Antegrade Access
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare relevant clinical outcomes in patients requiring percutaneous nephrostomy for urolithiasis treatment between those who undergo an antegrade approach versus a retrograde approach and to determine which clinical characteristics predict success of lithotomy with anterograde or retrograde percutaneous nephrostomy approaches.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone
Keywords
nephrostomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (retrograde nephrostomy)
Arm Type
Experimental
Arm Title
Control Group ( antegrade nephrostomy)
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
retrograde nephrostomy
Intervention Description
this will consist of one visit to a urologist for retrograde nephrostomy placement using a Retroperc device with lithotomy performed in the same visit and follow up at 4 weeks and 6 months.
Intervention Type
Device
Intervention Name(s)
antegrade nephrostomy
Intervention Description
this will consist of two visits, first to the interventional radiologist for antegrade nephrostomy placement followed by another visit to the urologist for lithotomy with follow up at 4 weeks and 6 months
Primary Outcome Measure Information:
Title
Treatment efficacy as measured by the time taken from diagnosis to nephrostomy access
Time Frame
end of procedure (about 4-8 weeks from diagnosis)
Title
Treatment efficacy as measured by total time of access operation.
Time Frame
end of procedure( about 90 minutes after start of procedure)
Title
Treatment efficacy as measured by total time of access operation fluoroscopy
Time Frame
end of procedure( about 90 minutes after start of procedure)
Title
Treatment efficacy as measured by total time of lithotomy operation
Time Frame
end of procedure(about 3 hours after start of procedure)
Title
Treatment efficacy as measured by total time of lithotomy operation fluoroscopy
Time Frame
(end of procedure)about 3 hours after start of procedure
Title
Treatment efficacy as measured by length of post-operative hospital stay
Time Frame
24 hours after procedure
Title
Number of patients that are stone free
Description
stone free is defined as <2mm on non-contrast computed tomography
Time Frame
6-12 weeks after procedure
Title
Number of patients with symptom free survival as defined as lack of flank pain
Time Frame
6-12 weeks after procedure
Title
Number of patients with symptom free survival as defined as lack of presence of urinary or gastrointestinal symptoms,
Time Frame
6-12 weeks after procedure
Title
Number of patients with symptom free survival as defined as lack of limitations to work
Time Frame
6-12 weeks after procedure
Title
Number of patients with symptom free survival as defined as lack of limitations to social or daily activities.
Time Frame
6-12 weeks after procedure
Secondary Outcome Measure Information:
Title
Number of patients with nephrostomy access adequate for stone treatment
Time Frame
end of procedure( abut 3 hours from start of procedure)
Title
Number of patients with normal vital signs
Time Frame
end of procedure( abut 3 hours from start of procedure)
Title
Number of patients with normal laboratory values
Description
laboratory values include complete metabolic panel and urinalysis
Time Frame
24 hours after procedure
Title
Number of patients with an infection rate which is defined as a positive culture within the study time period
Time Frame
6-12 weeks after procedure
Title
Number of patients that require pain medication (defined as discharge with an opioid prescription).
Time Frame
6-12 weeks after procedure

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -Renal pelvis and proximal ureteral stones >10 mm confirmed with non-contrast computed tomography Exclusion Criteria: Suspected pyelonephritis. Prior percutaneous nephrolithotomy procedure in affected kidney. Mid-ureteral or distal ureteral stones. Pregnancy. Anatomical abnormal kidney, including: Horseshoe Ectopic
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nadeem N Dhanani, MD,MPH
Phone
(713) 500-7337
Email
Nadeem.N.Dhanani@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Isidahomen
Phone
713-500-6086
Email
Amy.Isidahomen@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadeem N Dhanani, MD,MPH
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadeem N Dhanani, MD,MPH
Phone
713-500-7337
Email
Nadeem.N.Dhanani@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Amy Isidahomen
Phone
713-500-6086
Email
Amy.Isidahomen@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Outcomes of Percutaneous Nephrolithotomy Following Retrograde Percutaneous Nephrostomy Access Using Novel Device in Comparison to Antegrade Access

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