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Trial History Detail on 2011-02-08

CUHK_CCT00280

2010-12-22

Prospective

Nil

Departmental research funding

Urology Division, Department of Surgery, CUHK

Nil

Lee, Wai Man

4/F., Department of Surgery, Clinical Science Building, PWH

26321663

kimlwm@surgery.cuhk.edu.hk

Urology Division, Department of Surgery, CUHK

Prof. Ng, Chi Fai

4/F., Department of Surgery, Clinical Science Building, PWH

26322625

ngcf@surgery.cuhk.edu.hk

Urology Division, Department of Surgery, CUHK

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

Strategies to alleviate renal trauma – “START” trial

HONG KONG

Yes

2010-12-08

Renal Stone

Procedure

Extracorporeal shockwave lithotripsy

1 hour

Different starting energy and/ or a short pause comparing with the usual protocol.

• Adult patient (aged ≥ 18 years old).
• Renal stones planned for SWL
• Solitary radio-opaque stone of size less than or equal to 15mm

 Patients with more than 2 SWLs done before current SWL to the same kidney
 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)
 Patients with ureteric stent or nephrostomy tube in-situ
 Patients with conditions that may increase risk of developing renal scarring:
o Patients with any previous major procedures to the same kidney (including percutaneous nephrolithotomy, any kidney surgery, etc)
o 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,
o Patients with known bleeding tendency or on antiplatelet / anticoagulation therapy
o Patients with positive urine culture [9]
o 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

18

Nil

Both Male and Female

Interventional

Randomized

Dose comparison

Single-blind

Parallel

2010-12-30

320

Recruiting

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

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.

No

2015-07-06


Yes

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