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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01604304
First received: May 21, 2012
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Stone free rate [ Time Frame: Three months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01604304     History of Changes
Other Study ID Numbers: 2011.692
Study First Received: May 21, 2012
Last Updated: August 26, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Pathological Conditions, Anatomical
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi

ClinicalTrials.gov processed this record on August 28, 2014