Clinical trial NCT05022537: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Kidney Stone
Keywords: nephrostomy
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Treatment efficacy as measured by the time taken from diagnosis to nephrostomy access
timeFrame: end of procedure (about 4-8 weeks from diagnosis)
measure: Treatment efficacy as measured by total time of access operation.
timeFrame: end of procedure( about 90 minutes after start of procedure)
measure: Treatment efficacy as measured by total time of access operation fluoroscopy
timeFrame: end of procedure( about 90 minutes after start of procedure)
measure: Treatment efficacy as measured by total time of lithotomy operation
timeFrame: end of procedure(about 3 hours after start of procedure)
measure: Treatment efficacy as measured by total time of lithotomy operation fluoroscopy
timeFrame: (end of procedure)about 3 hours after start of procedure
measure: Treatment efficacy as measured by length of post-operative hospital stay
timeFrame: 24 hours after procedure
measure: Number of patients that are stone free
timeFrame: 6-12 weeks after procedure
measure: Number of patients with symptom free survival as defined as lack of flank pain
timeFrame: 6-12 weeks after procedure
measure: Number of patients with symptom free survival as defined as lack of presence of urinary or gastrointestinal symptoms,
timeFrame: 6-12 weeks after procedure
measure: Number of patients with symptom free survival as defined as lack of limitations to work
timeFrame: 6-12 weeks after procedure
measure: Number of patients with symptom free survival as defined as lack of limitations to social or daily activities.
timeFrame: 6-12 weeks after procedure
Secondary outcomes:
measure: Number of patients with nephrostomy access adequate for stone treatment
timeFrame: end of procedure( abut 3 hours from start of procedure)
measure: Number of patients with normal vital signs
timeFrame: end of procedure( abut 3 hours from start of procedure)
measure: Number of patients with normal laboratory values
timeFrame: 24 hours after procedure
measure: Number of patients with an infection rate which is defined as a positive culture within the study time period
timeFrame: 6-12 weeks after procedure
measure: Number of patients that require pain medication (defined as discharge with an opioid prescription).
timeFrame: 6-12 weeks after procedure
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Nadeem N Dhanani, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References: