Clinical trial NCT05894668: Perioperative Parameter and Treatment Outcomes of ECIRS in Asia
Official title: A Prospective Assessment of the Perioperative Parameter and Treatment Outcomes of Endoscopic Combined Intrarenal Surgery (ECIRS) in Asia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Stone
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with urinary stones and planned for ECIRS

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

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Target Stone status
timeFrame: up to 1 year
measure: Treatment related complication
timeFrame: Thirty days after the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Alice Ho Miu Ling Nethersole Hospital
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
city: Sheung Shui
country: Hong Kong
facility: North District Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Chi Fai NG, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.