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

Kidney Stone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05022537
• Other study ID #: HSC-MS-20-1269
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Nadeem N Dhanani, MD,MPH
• Phone: (713) 500-7337
• Email: Nadeem.N.Dhanani[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone

Intervention

Device:
• retrograde nephrostomy
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.
• antegrade nephrostomy
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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment efficacy as measured by the time taken from diagnosis to nephrostomy access		end of procedure (about 4-8 weeks from diagnosis)
Primary	Treatment efficacy as measured by total time of access operation.		end of procedure( about 90 minutes after start of procedure)
Primary	Treatment efficacy as measured by total time of access operation fluoroscopy		end of procedure( about 90 minutes after start of procedure)
Primary	Treatment efficacy as measured by total time of lithotomy operation		end of procedure(about 3 hours after start of procedure)
Primary	Treatment efficacy as measured by total time of lithotomy operation fluoroscopy		(end of procedure)about 3 hours after start of procedure
Primary	Treatment efficacy as measured by length of post-operative hospital stay		24 hours after procedure
Primary	Number of patients that are stone free	stone free is defined as <2mm on non-contrast computed tomography	6-12 weeks after procedure
Primary	Number of patients with symptom free survival as defined as lack of flank pain		6-12 weeks after procedure
Primary	Number of patients with symptom free survival as defined as lack of presence of urinary or gastrointestinal symptoms,		6-12 weeks after procedure
Primary	Number of patients with symptom free survival as defined as lack of limitations to work		6-12 weeks after procedure
Primary	Number of patients with symptom free survival as defined as lack of limitations to social or daily activities.		6-12 weeks after procedure
Secondary	Number of patients with nephrostomy access adequate for stone treatment		end of procedure( abut 3 hours from start of procedure)
Secondary	Number of patients with normal vital signs		end of procedure( abut 3 hours from start of procedure)
Secondary	Number of patients with normal laboratory values	laboratory values include complete metabolic panel and urinalysis	24 hours after procedure
Secondary	Number of patients with an infection rate which is defined as a positive culture within the study time period		6-12 weeks after procedure
Secondary	Number of patients that require pain medication (defined as discharge with an opioid prescription).		6-12 weeks after procedure