Clinical trial NCT06110299: Room Air a Safe Alternative to Dye Injection in Ureterography
Official title: Room Air vs Iohexol Injection in URS
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ureteral Obstruction
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* all patients undergoing Urs

Exclusion Criteria:

* no

Primary outcomes:
measure: no air embolism
timeFrame: 3 months
Secondary outcomes:
measure: identification of ureter
timeFrame: intraoperative
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.
citation: 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.
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.