Mini- Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy for High Density Renal Stones

NCT ID: NCT04346134

Last Updated: 2022-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-14
• Study Completion Date: 2021-03-01

Brief Summary

Several studies were conducted to compare extracorporeal shockwave lithotripsy (SWL) and percutaneous nephrolithotomy (PNL) as treatment options for medium size lower caliceal high dense stones. However, no studies compared these options for non- lower polar stones.

In the present study the investigators will compare mini-PNL and SWL in treatment of non- lower polar, medium size, high dense renal stones in reference to the stone free rate and safety of the procedures.

Pre-operative evaluation including abdominal non-contrasted computed tomography will be performed for all patients. Patients will be randomly allocated into two equal groups and will be treated by either mini-PNL or SWL. postoperative, patients will be followed by regularly for 3 months. the outcome of the procedures will be evaluated and compared between groups.

Detailed Description

The European guidelines put SWL and PNL as an equal treatment options for non- lower polar renal stones from 10 to 20 mm size regardless of density. However, several studies reported markedly reduced SFR after SWL with increased density. Also, in practice, the investigators noticed a high failure rate in renal stones with high density regardless of stone size. Several studies were conducted to compare SWL and PNL as treatment options for medium size lower caliceal stones. However, no studies compared these options for non- lower polar stones.

In the present study the investigators will compare mini-PNL and SWL in treatment of non- lower polar, medium size, high dense renal stones in reference to the SFR and safety of the procedures.

Adult patients with renal stones who agree to participate in the study will evaluated evaluated by full medical history taking and thorough physical examination, urinalysis, urine culture and antibiogram, complete blood cell count (CBC), serum creatinine, liver function tests and coagulation profile. Plain abdominal X-ray for kidney, ureters and urinary bladders (KUB), abdominal ultrasonography and abdominal non-contrasted computed tomography (NCCT). Preoperative assessment of renal anatomy and stone characteristics will be based on the findings of abdominal NCCT.

patients with high density (>1000 HU), non-lower polar, single renal stone of 10 to 20 mm size will be randomly divided into 2 equal groups. mini-PNL group, in which PNL procedures will be performed using miniature nephroscope and SWL group, in which SWL procedures will be performed using Dornier Lithotripter. SWL will be performed for a maximum of 3 sessions.

Patients will be followed up regularly, post-operatively for 3 months. NCCT will be performed after 3 months for detection of stone free status. Baseline data, intra-operative and post-operative parameters will be compared between groups.

Conditions

Renal Stone; Extracorporeal Shockwave Lithotripsy; Percutaneous Nephrolithotomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

mini-PNL group

In which percutaneous nephrolithotomy will be performed using miniature nephroscope.

Group Type: EXPERIMENTAL

mini-PNL

Intervention Type: PROCEDURE

Percutaneous nephrolithotomy using miniature nephroscope. The procedure will be performed under general or spinal anesthesia under fluoroscopy guidance.

SWL group

In which extracorporeal shock wave lithotripsy will be performed using Dornier lithotripter SII

Group Type: EXPERIMENTAL

SWL

Intervention Type: PROCEDURE

Extracorporal shockwave lithotripsy using Dornier SII lithotripter. the procedure will be performed under sedoanalgesia, and fluoroscopy will be used for stone localization; for a maximum of 3 SWL session.

Interventions

mini-PNL

Percutaneous nephrolithotomy using miniature nephroscope. The procedure will be performed under general or spinal anesthesia under fluoroscopy guidance.

Intervention Type: PROCEDURE

SWL

Extracorporal shockwave lithotripsy using Dornier SII lithotripter. the procedure will be performed under sedoanalgesia, and fluoroscopy will be used for stone localization; for a maximum of 3 SWL session.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Adult patients with high density (>1000 HU), non-lower polar, single renal stone of 10 to 20 mm size

Exclusion Criteria

• Pregnant women, morbid obesity, severe orthopaedic deformities, any co-morbidities precluding general anaesthesia or prone positioning, uncorrectable coagulation disorders, active urinary tract infection (UTI), stone in calyceal diverticulum, abnormal renal anatomy and urinary tract obstruction distal to the stone

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Abul-fotouh Ahmed

Professor of Urology and Andrology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Urology Department, Al-Azhar University Hospital

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Uro_Azhar_16_019

Identifier Type: -

Identifier Source: org_study_id