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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05894668
Other study ID # CRE-2023.172
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date March 31, 2029

Study information

Verified date May 2023
Source Chinese University of Hong Kong
Contact Chi Fai NG, MD
Phone 35052625
Email ngcf@surgery.cuhk.edu.hk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is an observational, international, multicenter, cohort study, prospectively collecting clinical data registry on consecutive patients with urinary stone undergoing ECIRS.


Description:

Patients diagnosed with urinary stones and planned for ECIRS in different centres will be recruited for the study. This registry collects clinical data on patients with ECIRS performed, includes baseline information on demography, symptoms, risk factors, and laboratory variables. Treatment information, perioperative outcomes, and follow-up details (up to 3 months after surgery) will also be collected. In summary, it captures patterns of presentation and treatment parameters, as well as perioperative and short-term outcomes of patients managed by ECIRS.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1000
Est. completion date March 31, 2029
Est. primary completion date December 31, 2028
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with urinary calculi - Undergoing Endoscopic Combined Intrarenal Surgery (ECIRS) - Agreed to consent for the study Exclusion Criteria: - Patients who have ECIRS for other conditions, such as urothelial cancer etc. - Patients who intraoperative record was incomplete. - Patients only have either PCNL or ureteroscopy done (not both)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
ECIRS
Endoscopic Combined Intrarenal Surgery

Locations

Country Name City State
Hong Kong Alice Ho Miu Ling Nethersole Hospital Hong Kong
Hong Kong Prince of Wales Hospital Shatin
Hong Kong North District Hospital Sheung Shui

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (5)

Chan SW, Ng CF, Man CW, Chung R, Li SK. A report on a randomly sampled questionnaire survey about renal stone disease in Hong Kong. Hong Kong Med J. 2008 Dec;14(6):427-31. — View Citation

Cracco CM, Scoffone CM. ECIRS (Endoscopic Combined Intrarenal Surgery) in the Galdakao-modified supine Valdivia position: a new life for percutaneous surgery? World J Urol. 2011 Dec;29(6):821-7. doi: 10.1007/s00345-011-0790-0. Epub 2011 Nov 6. — View Citation

Hamamoto S, Yasui T, Okada A, Taguchi K, Kawai N, Ando R, Mizuno K, Kubota Y, Kamiya H, Tozawa K, Kohri K. Endoscopic combined intrarenal surgery for large calculi: simultaneous use of flexible ureteroscopy and mini-percutaneous nephrolithotomy overcomes the disadvantageous of percutaneous nephrolithotomy monotherapy. J Endourol. 2014 Jan;28(1):28-33. doi: 10.1089/end.2013.0361. Epub 2013 Oct 24. — View Citation

Scoffone CM, Cracco CM, Cossu M, Grande S, Poggio M, Scarpa RM. Endoscopic combined intrarenal surgery in Galdakao-modified supine Valdivia position: a new standard for percutaneous nephrolithotomy? Eur Urol. 2008 Dec;54(6):1393-403. doi: 10.1016/j.eururo.2008.07.073. Epub 2008 Aug 8. — View Citation

Taguchi K, Cho SY, Ng AC, Usawachintachit M, Tan YK, Deng YL, Shen CH, Gyawali P, Alenezi H, Basiri A, Bou S, Djojodemedjo T, Sarica K, Shi L, Singam P, Singh SK, Yasui T. The Urological Association of Asia clinical guideline for urinary stone disease. Int J Urol. 2019 Jul;26(7):688-709. doi: 10.1111/iju.13957. Epub 2019 Apr 24. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Target Stone status The fragmentation rate of target stone up to 1 year
Primary Treatment related complication he 30-day complications will be graded according to the Clavien-Dindo classification Thirty days after the operation
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