Standard PCNL Vs Endoscopic Combined Intrarenal Surgery (ECIRS) for Complex Nephrolithiasis in Obese Patients

Renal Stone Clinical Trial

— ECIRS  

Official title:

Comparative Study Between Standard PCNL and Endoscopic Combined Intrarenal Surgery (ECIRS) in the Galdakaomodified Supine Valdivia (GMSV) Position for Complex Nephrolithiasis in Obese Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06085794
• Other study ID #: ECIRS complex stones in obese
• Status: Recruiting
• Phase: N/A
• Start date: July 25, 2022
• Est. completion date: January 2024

Study information

• Verified date: October 2023
• Source: Ain Shams University
• Contact: Moataz bellah M. Adel, Master degree
• Phone: +201065440699
• Email: mezzomezzo2[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary aim: comparing the efficacy of standard PCNL and endoscopic combined intrarenal surgery (ECIRS) in the Galdakao-modified Supine Valdivia (GMSV) position in a single session for the treatment of complex nephrolithiasis in obese patients. Secondary aim: comparing safety and complications of standard PCNL and ECIRS in the GMSV.

Description:

Complex nephrolithiasis including multiple peripheral or branched (partial or complete staghorn calculi) renal stones, is still currently an intractable problem for urologists to achieve stone-free status and minimize complication rates. According to the European Association of Urology Urolithiasis Guidelines, retrograde intrarenal surgery (RIRS) is recommended as first-line treatment for renal stones < 2 cm, and percutaneous nephrolithotomy (PCNL) is recommended as the gold standard for renal stones ≥ 2 cm in length. Obesity has been identified as an independent risk factor for stone formation in the United States. Obesity (BMI >35) also places surgical patients at a greater risk of complications, because of the increased incidence in this group of diabetes, hypertension, ischemic heart disease, postoperative deep venous thrombosis, and pulmonary embolism, and because of poor radiographic visualization, obscure anatomic landmarks, more difficult renal access, and inferior stone-free rates. Standard percutaneous nephrolithotomy (PCNL) is the recommended treatment by major guidelines. However, multiple tracts or sessions of PCNL were required to obtain a high stone-free rate (SFR) for complex renal calculi, especially staghorn stones, while procedure-related complications increased concomitantly. To acquire a higher SFR, full access to the entire intrarenal collecting system is the final goal of treatment for these patients suffering from multiple calyceal or peripheral satellite calculi, which is technically challenging by means of RIRS or PCNL monotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Partial or complete staghorn stones)
• Guy's Stone Score III or IV)
• Adult (18-60) years old patients
• Obese & super-obese patients (BMI > 30 kg/m 2).

Exclusion Criteria:

• Patients with congenital renal anomalies

Related Conditions & MeSH terms

• Kidney Calculi
• Nephrolithiasis
• Renal Stone

Intervention

Procedure:
• Endoscopic combined intrarenal surgery
Combined complex stone clearance with mini-nephroscope and flexible URS
• Percutaneous nephrolithotomy
Clearance of renal stone with nephroscope in prone position

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Cracco CM, Scoffone CM. ECIRS (Endoscopic Combined Intrarenal Surgery) in the Galdakao-modified supine Valdivia position: a new life for percutaneous surgery? World J Urol. 2011 Dec;29(6):821-7. doi: 10.1007/s00345-011-0790-0. Epub 2011 Nov 6. — View Citation

Cracco CM, Scoffone CM. Endoscopic combined intrarenal surgery (ECIRS) - Tips and tricks to improve outcomes: A systematic review. Turk J Urol. 2020 Nov;46(Supp. 1):S46-S57. doi: 10.5152/tud.2020.20282. Epub 2020 Aug 25. — View Citation

Grosso AA, Sessa F, Campi R, Viola L, Polverino P, Crisci A, Salvi M, Liatsikos E, Feu OA, DI Maida F, Tellini R, Traxer O, Cocci A, Mari A, Fiori C, Porpiglia F, Carini M, Tuccio A, Minervini A. Intraoperative and postoperative surgical complications after ureteroscopy, retrograde intrarenal surgery, and percutaneous nephrolithotomy: a systematic review. Minerva Urol Nephrol. 2021 Jun;73(3):309-332. doi: 10.23736/S2724-6051.21.04294-4. Epub 2021 Apr 22. — View Citation

Knoll T, Daels F, Desai J, Hoznek A, Knudsen B, Montanari E, Scoffone C, Skolarikos A, Tozawa K. Percutaneous nephrolithotomy: technique. World J Urol. 2017 Sep;35(9):1361-1368. doi: 10.1007/s00345-017-2001-0. Epub 2017 Jan 25. — View Citation

Liu YH, Jhou HJ, Chou MH, Wu ST, Cha TL, Yu DS, Sun GH, Chen PH, Meng E. Endoscopic Combined Intrarenal Surgery Versus Percutaneous Nephrolithotomy for Complex Renal Stones: A Systematic Review and Meta-Analysis. J Pers Med. 2022 Mar 28;12(4):532. doi: 10.3390/jpm12040532. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of PCNL vs ECIRS	Operative duration in minutes (from positioning to the end of the procedure) will be recorded for the two groups Stone-free status will be evaluated with a plain abdominal radiograph of the kidneys, ureters, and bladder (KUB) for radiopaque stones and NCCT for lucent stones before hospital discharge. Stone-free status is defined as no or small calyceal residuals of = 4 mm (clinically insignificant residual fragment) without infection.	2 days
Secondary	Safety and complication of PCNL Vs ECIRS	Intraoperative complications will be recorded and 30-day postoperative complications will be graded according to the modified Clavien classification.	1 month.