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Flexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in Renal Calculi (CALIX-1)

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ClinicalTrials.gov Identifier: NCT01604304
Recruitment Status : Completed
First Posted : May 23, 2012
Last Update Posted : August 27, 2014
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
Flexible ureteroscopy is a recent procedure to treat renal stone. Extracorporeal shockwave lithotripsy was the gold standard treatment for calculi between 5 and 20 mm. In literature, the two procedures are available to treat these stones with a good stone free rate. There is no prospective randomized study comparing these two treatments. Our study will define with a good level of evidence which technique is the best with regard to the stone free rate, secondary procedure rate and adverse effect.

Condition or disease Intervention/treatment Phase
Extracorporeal Shockwave Lithotripsy, Flexible Ureteroscopy Procedure: flexible ureteroscopy Procedure: extracorporeal shockwave lithotripsy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Flexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in 5 to 20 mm Renal Calculi, Efficacity Prospective Randomized Trial
Study Start Date : May 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Arm Intervention/treatment
Active Comparator: Extracorporeal shockwave lithotripsy
stone treatment using electroconductive technology
Procedure: extracorporeal shockwave lithotripsy
The lithotriptor is use with 1,1 Hz frequency and stop when patient get 1000 joules of energy or if there is a problem with tolerance of this treatment or if stone is broken

Active Comparator: Flexible ureteroscopy
intra renal retrograde surgery with or without laser and stone extraction
Procedure: flexible ureteroscopy
Flexible ureteroscopy will be use for 120 min max to treat renal stone. Laser, access sheath, baskets can be use to perform the technique.




Primary Outcome Measures :
  1. Stone free rate [ Time Frame: Three months ]
    Rate of stone free patient or patient with residual fragment ≤ 3 mm, 3 months after the treatment evaluated, will be compare. This outcome is measured with a tomodensitometry and compares with pre treatment exams.


Secondary Outcome Measures :
  1. Stone free rate in weight's sub group [ Time Frame: 3 months ]
    Each arm wil be divise in 3 sub group based on body mass index (20 to 25, 25 to 30, 30 to 35). We'll compare rate of efficacity in each sub group

  2. Stone free rate in sub group depending on stone diameters [ Time Frame: 3 months ]
    Each arm wil be divise in 3 sub group based on calculi diameter (5 to 10mm, 10 to 15 and 15 to 20). We'll compare rate of efficacity in each sub group

  3. Secondary procedure rate [ Time Frame: 3 months ]
    In each arm will be evaluate rate of secondary procedure needed to have the best stone free rate

  4. Serious and non serious adverse events [ Time Frame: 3 months ]
    In each arm will be evaluate rate of adverse event, type, severity.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with 5 to 20 mm renal stone
  • Age ≥ 18 years old
  • Patient agreement signed
  • BMI < 35
  • Contraception

Exclusion Criteria:

  • Pregnancy
  • Severe musculoskeletal deformities
  • Renal artery or aorta aneurysm
  • Pacemaker
  • Anesthesia contra indication
  • Psychiatric trouble or law protection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01604304


Locations
France
Service d'urologie, Hôpital Edouard Herriot
Lyon, France, 69 003
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Xavier Martin, PhD Hospices Civils de Lyon

Additional Information:
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01604304     History of Changes
Other Study ID Numbers: 2011.692
First Posted: May 23, 2012    Key Record Dates
Last Update Posted: August 27, 2014
Last Verified: August 2014

Keywords provided by Hospices Civils de Lyon:
stone
calculi
kidney
renal treatment
flexible ureteroscopy
extracoporeal shockwave lithotripsy
retrograde intra renal surgery

Additional relevant MeSH terms:
Calculi
Kidney Calculi
Nephrolithiasis
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi