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

This study has been completed.
Information provided by (Responsible Party):
Hospices Civils de Lyon Identifier:
First received: May 21, 2012
Last updated: August 26, 2014
Last verified: August 2014
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 Intervention
Extracorporeal Shockwave Lithotripsy, Flexible Ureteroscopy
Procedure: flexible ureteroscopy
Procedure: extracorporeal shockwave lithotripsy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Flexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in 5 to 20 mm Renal Calculi, Efficacity Prospective Randomized Trial

Resource links provided by NLM:

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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:
  • 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

  • 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

  • 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

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

Enrollment: 30
Study Start Date: May 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01604304

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

Additional Information:
Responsible Party: Hospices Civils de Lyon Identifier: NCT01604304     History of Changes
Other Study ID Numbers: 2011.692
Study First Received: May 21, 2012
Last Updated: August 26, 2014

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

Additional relevant MeSH terms:
Kidney Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urinary Calculi processed this record on May 22, 2017