Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00280

2 Trial Registration Date

2010-12-22

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Departmental research funding

5 Primary Sponsor

Urology Division, Department of Surgery, CUHK

6 Secondary Sponsor

Nil

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Lee, Wai Man

ii Address

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

iii Phone

26321663

iv Email

kimlwm@surgery.cuhk.edu.hk

v Affiliation

Urology Division, Department of Surgery, CUHK

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Prof. Ng, Chi Fai

ii Address

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

iii Phone

26322625

iv Email

ngcf@surgery.cuhk.edu.hk

v Affiliation

Urology Division, Department of Surgery, CUHK

vi Country

9 Official Scientific Title of the Study

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

10 Public Title

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

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Strategies to alleviate renal trauma – “START” trial

12 Countries of Recruitment

HONG KONG

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2010-12-08

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Renal Stone

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Extracorporeal shockwave lithotripsy

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

1 hour

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

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

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

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

ii Exclusion Criteria

 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

iii Age Minimum

18

iv Age Maximum

Nil

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Dose comparison

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2010-12-30

21 Target Sample Size

320

22 Recruitment Status

Recruiting

23 Primary Outcome

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

24 Secondary Outcome

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.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-07-06

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2011-02-08