NCT05894668

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
35mo left

Started Aug 2023

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Aug 2023Mar 2029

First Submitted

Initial submission to the registry

May 31, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 8, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2029

Last Updated

August 23, 2024

Status Verified

August 1, 2024

Enrollment Period

5.4 years

First QC Date

May 31, 2023

Last Update Submit

August 21, 2024

Conditions

Renal Stone

Outcome Measures

Primary Outcomes (2)

  • Target Stone status

    The fragmentation rate of target stone

    up to 1 year

  • Treatment related complication

    he 30-day complications will be graded according to the Clavien-Dindo classification

    Thirty days after the operation

Interventions

ECIRSOTHER

Endoscopic Combined Intrarenal Surgery

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with urinary stones and planned for ECIRS

You may qualify if:

  • Patients with urinary calculi
  • Undergoing Endoscopic Combined Intrarenal Surgery (ECIRS)
  • Agreed to consent for the study

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Alice Ho Miu Ling Nethersole Hospital

Hong Kong, Hong Kong

RECRUITING

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

North District Hospital

Sheung Shui, Hong Kong

RECRUITING

Related 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.

    PMID: 19060340BACKGROUND

  • 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.

    PMID: 31016804BACKGROUND

  • 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.

    PMID: 18715696BACKGROUND

  • 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.

    PMID: 22057344BACKGROUND

  • 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.

    PMID: 23987470BACKGROUND

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Study Officials

  • Chi Fai NG, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi Fai NG, MD

CONTACT

35052625ngcf@surgery.cuhk.edu.hk

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 31, 2023

First Posted

June 8, 2023

Study Start

August 1, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

March 31, 2029

Last Updated

August 23, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

HK(3)