Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00260

2 Trial Registration Date

2010-02-11

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

The Chinese University of Hong Kong

5 Primary Sponsor

The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Prof. Chi Fai Ng

ii Address

Department of Surgery, 4/F Clinical Science Building, Prince of Wales Hospital, Shatin, N.T., HKSAR

iii Phone

26322625

iv Email

ngcf@surgery.cuhk.edu.hk

v Affiliation

Department of Surgery, The Chinese University of Hong Kong

vi Country

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

i Name

Lo Kin Yin Anthony

ii Address

Department of Surgery, 4/F Clinical Science Building, Prince of Wales Hospital, Shatin, N.T., HKSAR

iii Phone

26323186

iv Email

anthonylo@surgery.cuhk.edu.hk

v Affiliation

Department of Surgery, 4/F Clinical Science Building, Prince of Wales Hospital, Shatin, N.T., HKSAR

vi Country

9 Official Scientific Title of the Study

Strategies To Prevent Renal Trauma – “START” trial: An Investigation on the Effect of Different Treatment Protocols in Minimizing Renal Injury during Extracoroperal Shock Wave Lithotripsy.

10 Public Title

Strategies To Prevent Renal Trauma – “START” trial: An Investigation on the Effect of Different Treatment Protocols in Minimizing Renal Injury during Extracoroperal Shock Wave Lithotripsy.

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Strategies To Avoid Renal Trauma – “START” trial.

12 Countries of Recruitment

Hong Kong, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2009-01-05

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 Shock Wave Lithotripsy

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

45 minutes (2Hz)

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

1 Patients will receive increasing power of SWs from 25% to 80% within 20 shocks. This is the standard SWL treatment protocol in our centre.
2 Patients will receive the first 100 shocks at 40% power and then followed by SWs at 80% power until the end of whole treatment.
3 Patients will receive the first 500 shocks at 40% power and then followed by SWs at 80% power until the end of whole treatment.
4 Patients will receive 500 shocks at 40% power, followed by a 3-minute pause and then further SWs at 80% power until the end of whole treatment.
5 Patients will receive 500 shocks at 80% power, followed by a 3-minute pause and then further SWs at 80% power until the end of whole treatment.

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

1. Adult patient (aged ≥ 18 years old);
2. Solitary radio-opaque renal stones of total size 5-20mm in maximal diameter as measured from plain radiography;
3. Clinically decided for SWL.

ii Exclusion Criteria

1. Stones associated with any renal or ureteric anatomical abnormality, such as caliceal diverticulum, horseshoe kidney, ureteropelvic junction obstruction etc.
2. Patients with ureteric stent or nephrostomy tube inserted.

iii Age Minimum

18

iv Age Maximum

80

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Open label

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

2010-02-17

21 Target Sample Size

250

22 Recruitment Status

Complete

23 Primary Outcome

The difference of the degree of renal injury related to SWL as measured by a panel of urine markers.

24 Secondary Outcome

Patient tolerance to various protocols by assessment of analgesic demand and pain score during treatment.

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

ChiCTR-TRC-10000793

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2013-04-05