Kidney Stones
Conditions
Keywords
percutaneous nephrolithotomy, PCNL, Occlusion Balloon Catheter, kidney stone
Brief summary
Occlusion Balloon catheter provides the ability to occlude the exit of the kidney pelvis during percutaneous nephrolithotomy (PCNL) and potentially prevents the migration of stone fragments into the ureter. The necessity for it might be questioned during supine PCNL due to the upward oblique position of the kidney. The objective of the study is to compare the presence of ureteral stone fragments upon completion of supine PCNL with and without using an occlusion balloon catheter (OBC).
Interventions
DEVICEOcclusion Balloon Catheter
The occlusion balloon catheter (OBC) is a type of ureteral catheter equipped with a small inflatable balloon at its tip. When inflated, the balloon can help prevent the migration of stone fragments.
DEVICE5FR Ureteral Catheter
The 5FR ureteral catheter (5FR-UC) is an open-ended small-caliber tube inserted at the beginning of PCNL to facilitate visualization of the collecting system using fluoroscopy and assist with renal access.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years and older. * Diagnosed with kidney stones and scheduled for PCNL. * Able and willing to provide informed consent.
Exclusion criteria
* Pregnant women * Urinary tract anomalies such as urinary diversion, previous ureteral reconstruction surgeries, horseshoe kidney, solitary kidney, duplicated system, urinary stricture disease, ureteropelvic junction obstruction, pelvic kidney, stone in calyceal diverticulum. * Prone procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Ureteral Stone Fragments Identified Endoscopically | During procedure, up to 5 hours | Endoscopic identification of ureteral stone fragments will be used to compare rate of ureteral stone fragments upon completion of PCNL while using OBC versus 5FR-UC. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Procedure | During procedure, up to 5 hours | Length of procedure is a common procedural outcome of endourologic procedures. |
| Number of Participants With Intraoperative Complications | During procedure, up to 5 hours | Number of participants with intraoperative complications, a common procedural outcome of endourologic procedures |
| Number of Participants With Stent Placement | during procedure, up to 5 hours | Number of participants with stent placement during procedure |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMantu Gupta, MD
Icahn School of Medicine at Mount Sinai
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 57 years |
| eGFR | 84 mL/min/1.73m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 31 Participants |
| Side of body Left side | 33 Participants |
| Side of body Right side | 34 Participants |
| stone size | 20 mm |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 48 |
| other Total, other adverse events | 0 / 51 | 0 / 48 |
| serious Total, serious adverse events | 0 / 51 | 0 / 48 |
Outcome results
None listed