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Completed

NCT Number: NCT01604304

Flexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in Renal Calculi

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.

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Key information

Conditions

Extracorporeal Shockwave Lithotripsy, Flexible Ureteroscopy Calculi Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service d'urologie, Hôpital Edouard Herriot

Lyon, 69 003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

flexible ureteroscopy

Procedure

Flexible ureteroscopy will be use for 120 min max to treat renal stone. Laser, access sheath, baskets can be use to perform the technique.

extracorporeal shockwave lithotripsy

Procedure

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Flexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in 5 to 20 mm Renal Calculi, Efficacity Prospective Randomized Trial

Acronym: CALIX-1

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 23, 2012
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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