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A prospective study to investigate the effect of different treatment protocols on renal injury during extracorporeal shockwave lithotripsy

A prospective study to investigate the effect of different treatment protocols on renal injury during extracorporeal shockwave lithotripsy

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10001134
Enrollment
Unknown
Registered
2010-12-22
Start date
2011-02-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Stone

Interventions

Two groups:Extracorporeal shockwave lithotripsy vs Different starting energy and/ or a short pause comparing with the usual protocol for 1 hour

Sponsors

Urology Division, Department of Surgery, Chinese University, Hong Kong
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Adult patient (aged >=18 years old); 2. Renal stones planned for SWL; 3. Solitary radio-opaque stone of size less than or equal to 15mm.

Exclusion criteria

Exclusion criteria: 1. Patients with more than 2 SWLs done before current SWL to the same kidney; 2. Patients with SWL / nephrostomy tube insertion within 90 days of current SWL (to minimize the effect of previous procedure on the assessment of renal injury secondary to current SWL); 3. Patients with ureteric stent or nephrostomy tube in-situ; 4. Patients with conditions that may increase risk of developing renal scarring: (1) Patients with any previous major procedures to the same kidney (including percutaneous nephrolithotomy, any kidney surgery, etc); (2) Chronic renal impairment Defined as serum creatinine level 1.5x above the upper limit of serum level; this may help to exclude patients with significant underlying renal pathology that lead to progressive renal fibrosis; Patients with increased risk of haematoma formation, including; Patients with known bleeding tendency or on antiplatelet / anticoagulation therapy; (1) Patients with positive urine culture [9]; (2) Patients with uncontrolled hypertension prior to SWL (BP > 150/90) [9]; Patients with renal stone(s) that expected to require more than 1 section of SWL for treatment.

Design outcomes

Primary

MeasureTime frame
ncidence of renal haematoma (perirenal and intrarenal) developed after SWL as assessed by imaging on Day-2 after treatment.;

Secondary

MeasureTime frame
Change in urine markers for acute kidney injury after SWL, change in urine markers for renal fibrosis after SWL, incidence of new onset hypertension, response of patients to the treatment and incidence of unplanned hospital visit and complications within 30 days after SWL.;

Countries

China

Contacts

Public ContactProf. Ng, Chi Fai
ngcf@surgery.cuhk.edu.hk+852 26322625

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026