Laser Versus Ultrasonic Lithotripsy in Percutaneous Nephrolithotomy for Staghorn Stones

NCT ID: NCT01922414

Last Updated: 2015-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Kidney Stones

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Laser

Patients will undergo Laser lithotripsy

Group Type ACTIVE_COMPARATOR

Laser

Intervention Type DEVICE

Patients will undergo laser lithotripsy durin PNL

Ultrasonic

Patients will undergo ultrasonic lithotripsy

Group Type ACTIVE_COMPARATOR

Ultrasonic

Intervention Type DEVICE

Patients will undergo ultrasonic lithotripsy during PNL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Laser

Patients will undergo laser lithotripsy durin PNL

Intervention Type DEVICE

Ultrasonic

Patients will undergo ultrasonic lithotripsy during PNL

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ahmed R. EL-Nahas

Assistant Professor of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ahmed R. EL-Nahas, MD

Role: PRINCIPAL_INVESTIGATOR

faculty of medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Urology and Nephrology Center

Al Mansurah, Dakhlia, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

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. doi: 10.1097/01.ju.0000161171.67806.2a. No abstract available.

Reference Type BACKGROUND
PMID: 15879803 (View on PubMed)

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. doi: 10.1097/00042307-200207000-00003.

Reference Type BACKGROUND
PMID: 12072646 (View on PubMed)

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. doi: 10.1016/j.urology.2004.09.069.

Reference Type BACKGROUND
PMID: 15780354 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20232221 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 22509933 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24083829 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22465085 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21774666 (View on PubMed)

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. doi: 10.1016/j.urology.2006.08.1114.

Reference Type RESULT
PMID: 17270603 (View on PubMed)

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.

Reference Type RESULT
PMID: 19732015 (View on PubMed)

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.

Reference Type RESULT
PMID: 17902519 (View on PubMed)

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. Epub 2010 Dec 16.

Reference Type RESULT
PMID: 21166763 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Staghorn Laser vs US

Identifier Type: OTHER

Identifier Source: secondary_id

Staghorn Laser

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Laser Lithotripsy for Ureteral Stones
NCT06465784 COMPLETED PHASE4
Lithotripsy for the Treatment of Gallstones
NCT00042549 TERMINATED PHASE4