Skip to content

Cost-Effectiveness of Different Treatment Options for Lower Calyceal Stones

Cost-Effectiveness of Different Treatment Options for Lower Calyceal Stones of 1 to 2 Centimeters: A Prospective, Randomized Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03614247
Enrollment
175
Registered
2018-08-03
Start date
2007-01-01
Completion date
2018-05-01
Last updated
2018-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Calculi

Keywords

Lower calyceal stone, cost-effectiveness, percutaneous nephrolithotomy, retrograde intrarenal surgery

Brief summary

The aim of the present study to perform a full cost analysis for the complete clearance of calyceal stones by retrograde intrarenal surgery (RIRS) and percutaneous nephrolithotomy (PNL) for the treatment of lower calyceal stones between 1 and 2 centimeters (cm) in size.

Detailed description

The lifelong prevalence of urinary system stone disease is approximately 15%. The lower calyx is the most common location where renal calculi occur. Because anatomical factors preclude spontaneous passage in this area, the need for treatment is more likely in lower calyceal stones. The European Association of Urology (EAU) suggests percutaneous nephrolithotomy (PNL) for stones larger than 2 centimeters (cm) and shock wave lithotripsy (SWL) or retrograde intrarenal surgery (RIRS) for stones smaller than 1cm as a first option, but controversy continues regarding the best treatment option for medium-sized lower calyceal stones of between 1cm and 2cm. Medical costs are divided into two components: direct and indirect. Direct costs encompass all medical expenditures (e.g., drugs, hospital bed, all consumable and non-consumable materials used during the operation), while indirect costs include loss of working days for the patient. The stone-free rates (SFR) are reported as approximately 60% and 90% for one session of RIRS and PNL, respectively; however, no physician can guarantee a 100% SFR for one session. For this reason, a full cost analysis must include the direct and indirect costs of both the first and all auxiliary procedures. The aim of this study was to perform a full cost analysis for the complete clearance of calyceal stones by RIRS and all PNL types for the treatment of lower calyceal stones between 1cm and 2cm in size.

Interventions

PROCEDURERetrograde intrarenal surgery

The procedure was performed with the patient in the dorsal lithotomy position under general anesthesia. Firstly, diagnostic ureteroscopy was done with a 6/7.5 Fr semi-rigid ureteroscope (Richard Wolf, Knittlingen, Germany). A 0.035mm double-tipped sensor guidewire was placed to the renal pelvis. A 10/12 Fr ureteric access sheath (Cook Medical, Indiana, USA) was used. A 7.5 Fr flexible ureteroscope (Flex X2, Karl Storz, Tuttlingen, Germany) was used for the main procedure. The stones were fragmented using a Holmium:Yttrium Aluminum Garnet laser (272 microns). At the end of each procedure, a double-j ureteric catheter and urethral catheter were routinely placed.

PROCEDUREMicro-PNL

The PNL procedures were performed with the patient in the prone position under general anesthesia. A 6-F ureteric catheter was placed at the beginning of the procedure. Calyceal access was provided using a 22-G Chiba needle. A 0.038mm sensor-tipped guidewire was inserted through the calyceal puncture into the renal pelvis. After tract dilatation, a sheath was inserted. The instruments used were a 4.8 Fr for micro PNL (PolyDiagnost, Pfaffenhofen, Germany). Stone fragmentation was carried out using laser in micro PNL. No nephrostomy was placed in any patient whom underwent micro PNL surgical technique. A double- j stent was placed in necessary (e.g., pelvis perforation, rest stone, stone migration to ureter). A urethral catheter was placed routinely in all patients.

PROCEDUREUltra-mini PNL

The PNL procedures were performed with the patient in the prone position under general anesthesia. A 6-F ureteric catheter was placed at the beginning of the procedure. Calyceal access was provided using a 22-G Chiba needle. A 0.038mm sensor-tipped guidewire was inserted through the calyceal puncture into the renal pelvis. After tract dilatation, a sheath was inserted. The instruments used were a 7.5 Fr for ultramini PNL (Karl Storz, Tuttlingen, Germany). Stone fragmentation was carried out using laser in ultramini PNL. No nephrostomy was placed in any patient whom underwent ultramini PNL surgical technique. A double- j stent was placed in necessary (e.g., pelvis perforation, rest stone, stone migration to ureter). A urethral catheter was placed routinely in all patients.

PROCEDUREMini-PNL

The PNL procedures were performed with the patient in the prone position under general anesthesia. A 6-F ureteric catheter was placed at the beginning of the procedure. Calyceal access was provided using a 22-G Chiba needle. A 0.038mm sensor-tipped guidewire was inserted through the calyceal puncture into the renal pelvis. After tract dilatation, a sheath was inserted. The instruments used were a 12 Fr for mini PNL (Karl Storz, Tuttlingen, Germany). Stone fragmentation was carried out using pneumatic, ultrasonic or laser in mini PNL. No nephrostomy was placed in any patient whom underwent mini PNL surgical technique. A double- j stent was placed in necessary (e.g., pelvis perforation, rest stone, stone migration to ureter). A urethral catheter was placed routinely in all patients.

PROCEDUREStandard PNL

The PNL procedures were performed with the patient in the prone position under general anesthesia. A 6-F ureteric catheter was placed at the beginning of the procedure. Calyceal access was provided using a 22-G Chiba needle. A 0.038mm sensor-tipped guidewire was inserted through the calyceal puncture into the renal pelvis. After tract dilatation, a sheath was inserted. The instruments used were a 24 Fr for standard PNL (Karl Storz, Tuttlingen, Germany). Stone fragmentation was carried out using pneumatic, ultrasonic or laser in standard PNL. A nephrostomy was placed in all standard PNL patients at the end of the procedure

Sponsors

Ministry of Health, Turkey
CollaboratorOTHER_GOV
Ankara Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Patients who had a lower calyceal stone between 1cm and 2cm in size

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Patients who had a lower calyceal stone between 1cm and 2 cm in size

Exclusion criteria

* solitary or anomaly (horseshoe or pelvic kidney) kidney, * renal insufficiency, * pregnancy, * patient younger than 18 or older than 75 years, * non-interrupted antithrombotic medication before surgery, * urinary tract infection, * double-j or nephrostomy insertion before surgery

Design outcomes

Primary

MeasureTime frameDescription
Stone free status3 monthsStone-free was defined as no rest stone or ≤ 3mm clinical insignificance rest stone

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026