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Laser Versus Ultrasonic Lithotripsy in Percutaneous Nephrolithotomy for Staghorn Stones

Primary Purpose

Kidney Stones

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laser
Ultrasonic
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Stones focused on measuring Staghorn stones, Percutaneous nephrolithotomy, Laser, Randomized trial, Lithotripsy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Urology and Nephrology Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Laser

Ultrasonic

Arm Description

Patients will undergo Laser lithotripsy

Patients will undergo ultrasonic lithotripsy

Outcomes

Primary Outcome Measures

Stone Free rate
Assessment of stone free rate after 3 months from treatment using NCCT

Secondary Outcome Measures

Assessment of the safety of each technique
Measurement of complication rates, classifications of the severity of complications
Operative time
Measurement of the time from start of ureteral catheter fixation till the fixation of the nephrostomy tube
Hospital stay

Full Information

First Posted
August 1, 2013
Last Updated
August 10, 2015
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT01922414
Brief Title
Laser Versus Ultrasonic Lithotripsy in Percutaneous Nephrolithotomy for Staghorn Stones
Official Title
Laser Versus Ultrasonic Lithotripsy in Percutaneous Nephrolithotomy for Staghorn Stones
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stones
Keywords
Staghorn stones, Percutaneous nephrolithotomy, Laser, Randomized trial, Lithotripsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser
Arm Type
Active Comparator
Arm Description
Patients will undergo Laser lithotripsy
Arm Title
Ultrasonic
Arm Type
Active Comparator
Arm Description
Patients will undergo ultrasonic lithotripsy
Intervention Type
Device
Intervention Name(s)
Laser
Intervention Description
Patients will undergo laser lithotripsy durin PNL
Intervention Type
Device
Intervention Name(s)
Ultrasonic
Intervention Description
Patients will undergo ultrasonic lithotripsy during PNL
Primary Outcome Measure Information:
Title
Stone Free rate
Description
Assessment of stone free rate after 3 months from treatment using NCCT
Time Frame
Patients will be followed for 3 months after the procedure
Secondary Outcome Measure Information:
Title
Assessment of the safety of each technique
Description
Measurement of complication rates, classifications of the severity of complications
Time Frame
From the start of the operation till 3 months after discharge from the hospital
Title
Operative time
Description
Measurement of the time from start of ureteral catheter fixation till the fixation of the nephrostomy tube
Time Frame
An expected average of 3 hours
Title
Hospital stay
Time Frame
up to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Complete staghorn stones (filling the renal pelvis and branching to 3 major calyces Age: 18-70 years Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed R. EL-Nahas, MD
Organizational Affiliation
faculty of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology and Nephrology Center
City
Mansoura
State/Province
Dakhlia
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
15879803
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. doi: 10.1097/01.ju.0000161171.67806.2a. No abstract available.
Results Reference
background
PubMed Identifier
12072646
Citation
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.
Results Reference
background
PubMed Identifier
15780354
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. doi: 10.1016/j.urology.2004.09.069.
Results Reference
background
PubMed Identifier
20232221
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.
Results Reference
background
PubMed Identifier
22509933
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. No abstract available.
Results Reference
background
PubMed Identifier
24083829
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.
Results Reference
background
PubMed Identifier
22465085
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.
Results Reference
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PubMed Identifier
21774666
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.
Results Reference
background
PubMed Identifier
17270603
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. doi: 10.1016/j.urology.2006.08.1114.
Results Reference
result
PubMed Identifier
19732015
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.
Results Reference
result
PubMed Identifier
17902519
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.
Results Reference
result
PubMed Identifier
21166763
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. Epub 2010 Dec 16.
Results Reference
result

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Laser Versus Ultrasonic Lithotripsy in Percutaneous Nephrolithotomy for Staghorn Stones

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