Perioperative Parameter and Treatment Outcomes of ECIRS in Asia

Renal Stone Clinical Trial

Official title:

A Prospective Assessment of the Perioperative Parameter and Treatment Outcomes of Endoscopic Combined Intrarenal Surgery (ECIRS) in Asia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05894668
• Other study ID #: CRE-2023.172
• Status: Not yet recruiting
• 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
• 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
• 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)

Related Conditions & MeSH terms

• Kidney Calculi
• Nephrolithiasis
• Renal Stone

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