Laser Versus Ultrasonic Lithotripsy in Percutaneous Nephrolithotomy for Staghorn Stones

Kidney Stones Clinical Trial

Official title:

Laser Versus Ultrasonic Lithotripsy in Percutaneous Nephrolithotomy for Staghorn Stones

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01922414
• Other study ID #: Staghorn Laser
• Secondary ID: Staghorn Laser v
• Status: Completed
• Phase: N/A
• First received: August 1, 2013
• Last updated: August 10, 2015
• Start date: August 2011
• Est. completion date: September 2014

Study information

• Verified date: August 2015
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

This study will be conducted to compare the results of Laser and ultrasonic lithotripsy in disintegration of staghorn stones during percutaneous nephrolithotomy.

Description:

Patients with complete staghorn stones who are eligible to percutaneous nephrolithotomy (PNL) will be randomized between two groups.

Group 1: will undergo Laser lithotripsy during PNL Group 2: will undergo ultrasonic lithotripsy during PNL

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Complete staghorn stones (filling the renal pelvis and branching to 3 major calyces

2. Age: 18-70 years

Exclusion Criteria:

1. Congenital renal anomalies such as horse shoe kidney.

2. Contraindications to PNL such as bleeding tendency and uncontrolled hypertension.

3. Associated pathological features requiring open intervention such as UPJO

4. Partial staghorn stones (filling the renal pelvis and branching to 2 major calyces)

5. Giant staghorn stone (very large staghorn stone that branch and re-branch in hugely dilated calyceal system)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Kidney Stones
• Nephrolithiasis

Intervention

Device:
• Laser
Patients will undergo laser lithotripsy durin PNL
• Ultrasonic
Patients will undergo ultrasonic lithotripsy during PNL

Locations

Country	Name	City	State
Egypt	Urology and Nephrology Center	Mansoura	Dakhlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (12)

Bagley DH. Expanding role of ureteroscopy and laser lithotripsy for treatment of proximal ureteral and intrarenal calculi. Curr Opin Urol. 2002 Jul;12(4):277-80. Review. — View Citation

Desai M, De Lisa A, Turna B, Rioja J, Walfridsson H, D'Addessi A, Wong C, Rosette On Behalf Of The Croes Pcnl Study Group J. The clinical research office of the endourological society percutaneous nephrolithotomy global study: staghorn versus nonstaghorn stones. J Endourol. 2011 Aug;25(8):1263-8. doi: 10.1089/end.2011.0055. Epub 2011 Jul 20. — View Citation

El-Nahas AR, Eraky I, Shokeir AA, Shoma AM, El-Assmy AM, El-Tabey NA, El-Kappany HA, El-Kenawy MR. Long-term results of percutaneous nephrolithotomy for treatment of staghorn stones. BJU Int. 2011 Sep;108(5):750-4. doi: 10.1111/j.1464-410X.2010.09942.x. E — View Citation

el-Nahas AR, Eraky I, Shokeir AA, Shoma AM, el-Assmy AM, el-Tabey NA, Soliman S, Elshal AM, el-Kappany HA, el-Kenawy MR. Factors affecting stone-free rate and complications of percutaneous nephrolithotomy for treatment of staghorn stone. Urology. 2012 Jun;79(6):1236-41. doi: 10.1016/j.urology.2012.01.026. Epub 2012 Apr 1. — View Citation

Gu Z, Qi J, Shen H, Liu J, Chen J. Percutaneous nephroscopic with holmium laser and ultrasound lithotripsy for complicated renal calculi. Lasers Med Sci. 2010 Jul;25(4):577-80. doi: 10.1007/s10103-010-0769-x. Epub 2010 Mar 16. — View Citation

Jou YC, Shen CH, Cheng MC, Lin CT, Chen PC. High-power holmium:yttrium-aluminum-garnet laser for percutaneous treatment of large renal stones. Urology. 2007 Jan;69(1):22-5; discussion 25-6. — View Citation

Jou YC, Shen JH, Cheng MC, Lin CT, Chen PC. Percutaneous nephrolithotomy with holmium: Yttrium-aluminum-garnet laser and fiber guider--report of 349 cases. Urology. 2005 Mar;65(3):454-8. — View Citation

Malik HA, Tipu SA, Mohayuddin N, Sultan G, Hussain M, Hashmi A, Naqvi SA, Rizvi SA. Comparison of holmium: Yag laser and pneumatic lithoclast in percutaneous nephrolithotomy. J Pak Med Assoc. 2007 Aug;57(8):385-7. — View Citation

Mandal S, Goel A, Goyal NK. Re: Staghorn morphometry: a new tool for clinical classification and prediction model for percutaneous nephrolithotomy monotherapy. (From: Mishra S, Sabnis RB, Desai M. J Endourol 2012;26:6-14). J Endourol. 2012 Aug;26(8):1099. doi: 10.1089/end.2012.0088. Epub 2012 Apr 17. — View Citation

Preminger GM, Assimos DG, Lingeman JE, Nakada SY, Pearle MS, Wolf JS Jr; AUA Nephrolithiasis Guideline Panel). Chapter 1: AUA guideline on management of staghorn calculi: diagnosis and treatment recommendations. J Urol. 2005 Jun;173(6):1991-2000. — View Citation

Qi S, Li L, Liu R, Qiao B, Zhang Z, Xu Y. Impact of stone branch number on outcomes of percutaneous nephrolithotomy for treatment of staghorn calculi. J Endourol. 2014 Feb;28(2):152-7. doi: 10.1089/end.2013.0333. Epub 2013 Nov 20. — View Citation

Sun Y, Gao X, Zhou T, Chen S, Wang L, Xu C, Hou J. 70 W holmium: yttrium-aluminum-garnet laser in percutaneous nephrolithotomy for staghorn calculi. J Endourol. 2009 Oct;23(10):1687-91. doi: 10.1089/end.2009.1536. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone Free rate	Assessment of stone free rate after 3 months from treatment using NCCT	Patients will be followed for 3 months after the procedure	No
Secondary	Assessment of the safety of each technique	Measurement of complication rates, classifications of the severity of complications	From the start of the operation till 3 months after discharge from the hospital	Yes
Secondary	Operative time	Measurement of the time from start of ureteral catheter fixation till the fixation of the nephrostomy tube	An expected average of 3 hours	No
Secondary	Hospital stay		up to 7 days	No