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NCT06110299 Clinical Trial

Room Air a Safe Alternative to Dye Injection in Ureterography

Ureteral Obstruction Clinical Trial

Official title:
Room Air vs Iohexol Injection in URS

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06110299
Other study ID # delination of PCS by air
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 29, 2023
Est. completion date December 29, 2023

Study information
Verified date October 2023
Source Assiut University
Contact abdelrahman M abdelkader
Phone 01068336396
Email abdelrahmanmohamed.aa@aun.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The procedure began in the Thirties .Retrograde pyelography is an essential step in most endoscopic procedure. This procedure is used as an investigation, with different indication in the past and the present, to delineate the ureter and pelvicalyceal system either before or after the operation, for example to detect any complication as a perforation and the need for stent placement. The procedure has an alternative, less invasive, the IVP. Multiple articles explored the use of air in the puncture of PCNL and to identify the posterior calyx, but to our knowledge there is no articles addressed the idea of air injection in the ureter. The greatest fear is air embolism or non-visualization of the ureter. The availability and cost of contrast material may be a problem, most urologist face

Description:

Our aim is to explore the feasibility of using Room air as a contrast material and check the safety of this procedure. Materials and methods: A pilot study in Assiut university hospital Urology department to evaluate the efficacy of air injection as a replacement dye injection in cases of endoscopy either in emergency or elective situation. Twenty patients were selected randomly, to evaluate the impact of retrograde pyelography (RPG) using air in cases of obstructed ureters and raised renal function.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 24
Est. completion date December 29, 2023
Est. primary completion date December 29, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - all patients undergoing Urs Exclusion Criteria: - no

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• air injection
delination of the ureter and pelvis by injecting air under C-ARM

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

References & Publications (5)

Garg A, Ali Khan MM, Singh P, Agarwal MK. Air embolism during percutaneous nephrolithotomy using air pyelogram during initial access: Does it really occur? Urol Ann. 2020 Jan-Mar;12(1):54-56. doi: 10.4103/UA.UA_10_19. Epub 2019 Nov 7. — View Citation

Gupta P, Choudhary GR, Pandey H, Madduri VKS, Singh M, Pallagani L. Air vs contrast pyelogram for initial puncture access in percutaneous nephrolithotomy: a randomized controlled trial. Urolithiasis. 2021 Jun;49(3):261-267. doi: 10.1007/s00240-020-01222-6. Epub 2020 Nov 7. — View Citation

Jangid DK, Sharma G, Yadav SS, Tomar V, Mathur R. A Comparative Study of Antegrade Air Pyelogram and Retrograde Air Pyelogram for Initial Puncture Access during Percutaneous Nephrolithotomy. J Clin Diagn Res. 2017 Apr;11(4):PC01-PC03. doi: 10.7860/JCDR/2017/24821.9724. Epub 2017 Apr 1. — View Citation

Lipkin ME, Mancini JG, Zilberman DE, Raymundo ME, Yong D, Ferrandino MN, Miller MJ, Yoshizumi TT, Preminger GM. Reduced radiation exposure with the use of an air retrograde pyelogram during fluoroscopic access for percutaneous nephrolithotomy. J Endourol. 2011 Apr;25(4):563-7. doi: 10.1089/end.2010.0431. Epub 2011 Mar 22. — View Citation

Sharma AK, Sharma S, Swain S, Goel G, Gujela A, Hota D, Mohapatra B, Sharma B. A comparative study of air pyelogram and contrast pyelogram for initial puncture access and to see its efficacy during percutaneous nephrolithotomy. Urol Ann. 2022 Oct-Dec;14(4):340-344. doi: 10.4103/ua.ua_80_21. Epub 2022 Sep 7. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary no air embolism 3 months
Secondary identification of ureter intraoperative
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