NCT01922414

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

August 11, 2015

Status Verified

August 1, 2015

Enrollment Period

3.1 years

First QC Date

August 1, 2013

Last Update Submit

August 10, 2015

Conditions

Kidney Stones

Keywords

Staghorn stonesPercutaneous nephrolithotomyLaserRandomized trialLithotripsy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Assessment of the safety of each technique

    From the start of the operation till 3 months after discharge from the hospital

  • Operative time

    An expected average of 3 hours

  • Hospital stay

    up to 7 days

Study Arms (2)

Laser

ACTIVE COMPARATOR

Patients will undergo Laser lithotripsy

Device: Laser

Ultrasonic

ACTIVE COMPARATOR

Patients will undergo ultrasonic lithotripsy

Device: Ultrasonic

Interventions

LaserDEVICE

Patients will undergo laser lithotripsy durin PNL

Laser
UltrasonicDEVICE

Patients will undergo ultrasonic lithotripsy during PNL

Ultrasonic

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Complete staghorn stones (filling the renal pelvis and branching to 3 major calyces
  • Age: 18-70 years

You may not qualify if:

  • Congenital renal anomalies such as horse shoe kidney.
  • Contraindications to PNL such as bleeding tendency and uncontrolled hypertension.
  • Associated pathological features requiring open intervention such as UPJO
  • Partial staghorn stones (filling the renal pelvis and branching to 2 major calyces)
  • Giant staghorn stone (very large staghorn stone that branch and re-branch in hugely dilated calyceal system)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, Dakhlia, 35516, Egypt

Location

Related Publications (12)

  • 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.

    PMID: 15879803BACKGROUND

  • 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.

    PMID: 12072646BACKGROUND

  • 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.

    PMID: 15780354BACKGROUND

  • 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.

    PMID: 20232221BACKGROUND

  • 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.

    PMID: 22509933BACKGROUND

  • 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.

    PMID: 24083829BACKGROUND

  • 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.

    PMID: 22465085BACKGROUND

  • 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.

    PMID: 21774666BACKGROUND

  • 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.

    PMID: 17270603RESULT

  • 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.

    PMID: 19732015RESULT

  • 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.

    PMID: 17902519RESULT

  • 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.

    PMID: 21166763RESULT

MeSH Terms

Conditions

Kidney Calculi

Interventions

LasersUltrasonography

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and SuppliesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Ahmed R. EL-Nahas, MD

    faculty of medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Urology

Study Record Dates

First Submitted

August 1, 2013

First Posted

August 14, 2013

Study Start

August 1, 2011

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

August 11, 2015

Record last verified: 2015-08

Locations

EG(1)