Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

cuhk_cct00166

2 Trial Registration Date

2008-07-15

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Research Grants Council General Research Fund

5 Primary Sponsor

Division of Urology, Department of Surgery, the Chinese University of Hong Kong

6 Secondary Sponsor

NA

Function

Please specify

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

i Name

Ng Chi Fai

ii Address

Department of Surgery, 4/F, Clinical Science Building, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, NT

iii Phone

Phone: 26322625/ 26323953, Fax: 26377974,

iv Email

e-mail: ngcf@surgery.cuhk.edu.hk

v Affiliation

Associate Professor, Department of Surgery

vi Country

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

i Name

Ng Chi Fai

ii Address

Department of Surgery, 4/F, Clinical Science Building, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, NT

iii Phone

Phone: 26322625/ 26323953, Fax: 26377974,

iv Email

e-mail: ngcf@surgery.cuhk.edu.hk

v Affiliation

Professor, Department of Surgery

vi Country

9 Official Scientific Title of the Study

A Prospective Study to Investigate the Effects of Different Shockwave Delivery Rates in Extracorporeal Shockwave Lithotripsy in Patients Suffer form Renal Calculi

10 Public Title

A Prospective Study to Investigate the Effects of Different Shockwave Delivery Rates in Extracorporeal Shockwave Lithotripsy in Patients Suffer form Renal Calculi

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Nil

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?

2008-03-13

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Renal calculi

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Extracorporeal Shockwave Lithotripsy (ESWL)

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

1 day

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

All patients will be treated with ESWL but at a different shockwave delivery rate among groups

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

Inclusion criteria are: •Adult patient (aged ≥ 18 years old). •Solitary radio-opaque renal stones of size 5-20mm in maximal diameter as measured from plain radiography •Clinically decided for primary ESWL

ii Exclusion Criteria

Exclusion criteria are: •Stones associated with any renal or ureteric anatomical abnormality, such as caliceal diverticulum, horseshoe kidney, ureteropelvic junction obstruction etc •Patients with ureteric stent or nephrostomy tube inserted •Patients with known history of cystine stone. •Patients with multiple stones in the same calix •Patient with history of allergy or any abnormal reaction alfentanil

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

2008-08-01

21 Target Sample Size

220

22 Recruitment Status

Complete

23 Primary Outcome

Primary outcomes: Successful treatment •Defined as either stone free or presence of clinically insignificant residual fragments (less than 4mm) at 12 weeks after one session of lithotripsy. •This will be assessed by plain radiography and non-contrast computerized tomogram.

24 Secondary Outcome

Secondary outcomes: •Degree of renal injury o The changes in the urine level (compared to pre-SWL level) of NAG, HA, NGAL and IL-18 of the two groups (different shockwave delivery rates) will be assessed. •Response of patients to the treatment o The following factors will be assessed and then compared between the two groups Maximal Pain score - Pain intensity verbal rating scale tool [8] will be used to assess the severity of pain at every 1000 shocks and at the end of treatment Analgesics consumption - the amount of additional usage of analgesics delivered by PCA will be recorded at the end of treatment.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2012-04-03

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000627

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2011-03-02