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Not yet recruitingNCT06110299Updated Oct 31, 2023

Room Air a Safe Alternative to Dye Injection in Ureterography

An interventional study of air injection in Ureteral Obstruction, sponsored by Assiut University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2023-10-31.

Sponsored by Assiut University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Ureteral Obstruction

Browse trials for

03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • all patients undergoing Urs

Exclusion criteria

Exclusion Criteria:

  • no
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    patients with obstructed ureters

    Diagnostic Test: air injection

Interventions

  • Diagnostic testair injection

    delination of the ureter and pelvis by injecting air under C-ARM

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What researchers measure

Primary outcomes

  1. no air embolism

    Time frame: 3 months

Secondary outcomes

  1. identification of ureter

    Time frame: intraoperative

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 33159536 ↗
  • 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. PubMed 36505991 ↗
  • 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. PubMed 28571203 ↗
  • 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. PubMed 32015618 ↗
  • 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. PubMed 21426236 ↗

Individual participant data

Plan to share: Undecided

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Registry details

Key details

Study ID
NCT06110299
Lead sponsor
Assiut University
Responsible party
Abdelrahman Mohamed Abdelkader (teaching assistant of urology & andrology, Assiut University) — Principal investigator
First posted
Oct 31, 2023
Start date
Oct 29, 2023 (estimated)
Primary completion
Dec 29, 2023 (estimated)
Completion
Dec 29, 2023 (estimated)
Last update
Oct 31, 2023

Study contacts

abdelrahman M abdelkader
Contact
abdelrahmanmohamed.aa@aun.edu.eg
01068336396

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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