NCT05911945

Failed Insertion of Ureteral Access Sheath During Flexible Ureterorenoscopy

Completed NA Last updated 23 June 2023

What this trial tests

NA trial testing Flexible Ureterorenoscopy in Kidney Calculi in 48 participants. Completed in 1 December 2021.

Timeline

10 September 2020

Primary endpoint
10 September 2021

1 December 2021

Quick facts

Lead sponsor	Haseki Training and Research Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	10 September 2020
Primary completion	10 September 2021
Estimated completion	1 December 2021
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Flexible Ureterorenoscopy
• Mini Percutaneous Nephrolithotomy

Conditions studied

• Kidney Calculi — all drugs for Kidney Calculi →

Sponsor

Haseki Training and Research Hospital

Who can join

18 and older, any sex, with Kidney Calculi. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Percutaneous nephrolithotomy (PNL) is the gold standard recommended treatment technique for kidney stones larger than 20 mm. For kidney stones between 10 - 20 mm, both shock wave lithotripsy (SWL) or flexible ureterorenoscopy (f-URS) are recommended as the first choice of treatment and PNL is recommended as the second. In patients who are planned to undergo f-URS, a ureteral access sheath (UAS) is placed in the ureter at the beginning of the operation in order to provide a better image, reduce intra-renal pressure, easier stone fragment retrieval and shorter operative time. In certain cases, such as ureteral stricture, kink or edema, the ureteral access sheath may not be able to successfully inserted into the ureter. At this stage, double-J (JJ) stent can be inserted into the ureter to create passive dilatation, and a second f-URS session can be scheduled a few weeks later. Another option is to perform PNL operation to the patient in the same session. In this randomized prospective study, we aimed to compare these two different surgical approaches in terms of patient comfort and surgical success in patients with kidney stones between 10 - 20 mm in which access sheath insertion was failed in the initial f-URS session.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Failed insertion of ureteral access sheath during flexible ureterorenoscopy: a randomized controlled trial comparing second session flexible ureterorenoscopy or same session mini percutaneous nephrolithotomy.
   Caglar U, Erbin A, Ucpinar B, Ayranci A, et al · · 2024 · cited 2× · PMID 37807032 · DOI 10.1007/s11255-023-03820-w