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

Not Applicable

Not yet recruiting

• Conditions: Kidney Stone
• Interventions: Device: retrograde nephrostomy; Device: antegrade nephrostomy

• Registration Number: NCT05022537
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-19
• Study First Submitted QC: 2021-08-19
• Study First Posted: 2021-08-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-11
• Study Start: 2025-03-01
• Primary Completion: 2026-03-01
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment (retrograde nephrostomy)	retrograde nephrostomy	-
Control Group ( antegrade nephrostomy)	antegrade nephrostomy	-

Primary Outcome Measures

Name	Time	Method
Number of patients with symptom free survival as defined as lack of flank pain	6-12 weeks after procedure
Number of patients with symptom free survival as defined as lack of limitations to social or daily activities.	6-12 weeks after procedure
Treatment efficacy as measured by total time of lithotomy operation fluoroscopy	(end of procedure)about 3 hours after start of procedure
Treatment efficacy as measured by the time taken from diagnosis to nephrostomy access	end of procedure (about 4-8 weeks from diagnosis)
Treatment efficacy as measured by total time of access operation fluoroscopy	end of procedure( about 90 minutes after start of procedure)
Treatment efficacy as measured by total time of lithotomy operation	end of procedure(about 3 hours after start of procedure)
Treatment efficacy as measured by length of post-operative hospital stay	24 hours after procedure
Number of patients with symptom free survival as defined as lack of presence of urinary or gastrointestinal symptoms,	6-12 weeks after procedure
Number of patients with symptom free survival as defined as lack of limitations to work	6-12 weeks after procedure
Treatment efficacy as measured by total time of access operation.	end of procedure( about 90 minutes after start of procedure)
Number of patients that are stone free	6-12 weeks after procedure	stone free is defined as \<2mm on non-contrast computed tomography

Secondary Outcome Measures

Name	Time	Method
Number of patients with normal laboratory values	24 hours after procedure	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	6-12 weeks after procedure
Number of patients with nephrostomy access adequate for stone treatment	end of procedure( abut 3 hours from start of procedure)
Number of patients that require pain medication (defined as discharge with an opioid prescription).	6-12 weeks after procedure
Number of patients with normal vital signs	end of procedure( abut 3 hours from start of procedure)

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States