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Trial History Detail on 2013-04-05

CUHK_CCT00260

2010-02-11

Prospective

Nil

The Chinese University of Hong Kong

The Chinese University of Hong Kong

N/A

Prof. Chi Fai Ng

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

26322625

ngcf@surgery.cuhk.edu.hk

Department of Surgery, The Chinese University of Hong Kong

Lo Kin Yin Anthony

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

26323186

anthonylo@surgery.cuhk.edu.hk

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

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.

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.

Strategies To Avoid Renal Trauma – “START” trial.

Hong Kong, China

Yes

2009-01-05

Renal stone

Procedure

Extracorporeal Shock Wave Lithotripsy

45 minutes (2Hz)

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.

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.

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.

18

80

Both Male and Female

Interventional

Randomized

Active

Open label

Parallel

2010-02-17

250

Complete

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

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

No

2015-07-06

ChiCTR-TRC-10000793

2010-05-04


Yes

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