Comparing Efficiency and Stone-Free Rates Mini PCNL vs Flex URS

Northwestern University

Status: Not yet enrolling

Conditions: Urolithiasis; Kidney Stones; Nephrolithiasis

Treatments: Device: ClearPETRA suction access sheath

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07072598

STU00222993

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Ureteroscopy

Active Comparator group

Description:

Patients randomized to this arm will have their stones treated using the method of Ureteroscopy in a standardized fashion. A second 0.035in sensor guidewire will then be advanced up to the renal pelvis with placement confirmed by fluoroscopy. Placement of a 12/14Fr ClearPETRA ureteral access sheath will be attempted. If this is unsuccessful, a 11/13Fr ClearPETRA ureteral access sheath will be advanced over the wire. If this is unsuccessful, a 5Fr open ended ureteral catheter will be placed and procedure will be converted to a miniPCNL. Lithotripsy will be performed with the MOSES 2.0 high power Holmium laser with settings of 0.3J and 120Hz or 2J and 20Hz depending on stone location and appearance. Stones will be extracted with the suction access sheath. A ureteral stent will be placed at the conclusion of the procedure.

Treatment:

Device: ClearPETRA suction access sheath

Device: ClearPETRA suction access sheath

Mini-PCNL

Active Comparator group

Description:

Will be performed by first starting with supine flexible cystoscopy to cannulate the ureteral orifice with a 5Fr open ended ureteral catheter. The patient will then be repositioned prone with 1-2 bumps placed transversely across the chest. Contrast will be instilled into the ureteral catheter and renal access will be obtained fluoroscopically with the triangulation technique. Once access is obtained, the tract will be dilated to 20Fr and a 18/20Fr ClearPETRA renal access sheath will be inserted to assess the collecting system. If there is concern that the 20Fr access is not sufficient to clear the stone, the tract will be upsized to 24 or 30Fr. The stones will be evacuated with the Trilogy Lithotripter and/or laser, suction and/or basket extraction. A ureteral stent will be placed at the conclusion of the procedure.

Treatment:

Device: ClearPETRA suction access sheath

Device: ClearPETRA suction access sheath