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

Civil Hospices of Lyon

Status: Completed

Conditions: Extracorporeal Shockwave Lithotripsy, Flexible Ureteroscopy

Treatments: Procedure: extracorporeal shockwave lithotripsy; Procedure: flexible ureteroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01604304

2011.692

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Extracorporeal shockwave lithotripsy

Active Comparator group

Description:

stone treatment using electroconductive technology

Treatment:

Procedure: extracorporeal shockwave lithotripsy

Flexible ureteroscopy

Active Comparator group

Description:

intra renal retrograde surgery with or without laser and stone extraction

Treatment:

Procedure: flexible ureteroscopy