Kidney Stones, Nephrolithiasis, Urolithiasis
Conditions
Keywords
kidney stone, Ureteroscopy, Mini-PCNL, ClearPETRA, kidney stone interventional treatment, kidney stone 1cm-3cm
Brief summary
The objective of the study is to compare the stone free rates with ureteroscopy utilizing the ClearPETRA suction ureteral access sheath, and mini-PCNL; both procedures and ClearPETRA sheaths are standard of care and are used regularly for stone treatment. Our primary objective is to assess the complete stone free rate with both procedures.
Detailed description
With the advent of mini-PCNLs, some endourologists have been utilizing the technique to treat renal calculi up to 3cm in size with better stone free rates and similar comorbidity compared to ureteroscopy. These procedures require percutaneous renal access, and it is associated with greater length of stay and fluoroscopy time. The ClearPETRA ureteral access sheath has shown great promise with improving stone free rates, decreasing intra-renal pressure and delivering some of the benefits of mini-PCNL without the added risk associated with obtaining percutaneous renal access. The ClearPETRA flexible suction ureteral access sheath anecdotally improves efficiency and allows endourologists to better clear stone debris when compared to traditional ureteral access sheaths. We have yet to see a comparison between suction ureteral access sheaths and mini-PCNL with the suction renal access sheath. Study Hypothesis: Compared to traditional access sheaths, using ClearPETRA access sheaths will result in an improvement in stone free rates with both modalities, with lower complications. Using ClearPETRA access sheaths in both modalities compared to traditional access sheaths should result in less of a difference in stone free rates between the ureteroscopy group and the mini-PCNL group.
Interventions
DEVICEClearPETRA suction access sheath
Ureteroscopy utilizing the ClearPETRA suction access sheath.
Sponsors
Northwestern University
KARL STORZ Endoscopy-America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients 18 years or older * Have a CT scan showing renal stones 1-3cm in length * Patients who will be able to read, understand, and complete patient questionnaires
Exclusion criteria
* Pregnant individuals * Those with anomalous renal anatomy * Patients with a urinary diversion (ex: Ileal conduit, reservoir, bladder substitute, etc.) * Any condition rendering patient medically unfit to undergo either procedure (Bleeding diasthesis) * Patients who lack decisional capacity * Patients who are non-english speakers\* * Non-recruitment of non-english speakers is due to the study being a small pilot study that is used to assess the stone free rate for patients treated with a ureteroscopy or mini-PCNL using ClearPETRA suction access sheaths in a small portion of our patient population seeking treatment for stones. The team also does not possess the bandwidth or personnel to consent patients who are non-English speaking.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone free rate | 4 weeks post-procedure | Stone free rate (no residual stone) on post-procedure CT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgery time | Procedure day (1 day) | Surgery time (minutes) |
| Complication rate | Procedure day (1 day) | Complication rate (Clavien-Dindo) (%) |
| Unplanned hospital visits | 90 days postoperatively | Unplanned hospital visits (ED/clinic) |
| Need for additional procedure | 90 days postoperatively | Need for additional procedure (within 90 days postoperatively) |
| Length of stay | Perioperatively (starting at Baseline/Procedure Date) | Length of stay hospital stay (if admitted post-procedure, or readmitted) |
| Inability to access ureter | Procedure day (1 day) | Intra-operative complications including inability to access the ureter ureteroscopically or need to upsize the renal access sheath with the percutaneous approach. |
| Need to upsize from 18Fr Sheath | Procedure day (1 day) | Need to upsize from 18Fr (PCNL group) |
| Occurrence of post-procedure sepsis | Perioperatively (starting at Baseline/Procedure Date) | Post-op sepsis |
| Hospital / patient costs (in total for procedure and any necessary postoperative hospital admissions or procedures related to the initial procedure). | Perioperatively (starting at Baseline/Procedure Date) | Any necessary postoperative hospital admissions or procedures related to the initial procedure |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmy E Krambeck, MD
Northwestern University
Outcome results
None listed