Flexible Ureteroscopy With and Without Ureteral Access Sheath in Treatment of Large Renal Stones

N

New Valley University

Status

Completed

Conditions

Large Renal Stones
Flexible Ureteroscopy
Ureteral Access Sheath

Treatments

Procedure: Flexible ureteroscope with ureteral access sheath
Procedure: Flexible ureteroscope without ureteral access sheath

Study type

Interventional

Funder types

Other

Identifiers

NCT06122129
0739-20233

Details and patient eligibility

About

The aim of this study is to evaluate the flexible ureteroscope (FURS) technique with and without ureteral access sheath (UAS).

Full description

Treating a large renal stone, more than 2 cm, is changing during the last decades. Technological innovations have led to a significant improvement in flexible ureteroscopes over recent years. Many authors have used flexible ureteroscope (FURS) with laser fragmentation as proved treating modality with high efficacy. Although percutaneous extraction of large renal stones is still the first option, it has higher and more severer complications than flexible ureteroscopy. FURS has developed into a standard diagnostic and treatment modality for upper urinary stone disease, transitional cell carcinoma and ureteral strictures. Indeed, more recently FURS is becoming a minimally invasive competitor to percutaneous nephrolithotomy for larger kidney stones as well as an accepted modality for localized treatment of small upper urinary tract transitional cell carcinoma. The use of ureteral access sheath (UAS) is widely recognized as a technique utilized to keep the intrarenal pressure low when performing FURS for larger and more complex stones, although some authors advocate its use for most renal stones. UASs are now produced with varying characteristics including various lengths, diameters, materials, dilator tip designs, radiopaque markers, and stiffness. However, it also rises surgical costs and may injure the ureteral wall. Most common reasons cited by urologists for using a UAS are to facilitate repeated entrance into the ureter and collecting system (as a time-saver), lower intrarenal pressure and protection of ureteroscope and ureter when extracting stone fragments. UAS has encouraged urologists in the fragmentation of large stones; it facilitates multiple entries and stone extraction during FURS.

Enrollment

84 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age > 18 years old.
  • Both sexes.
  • Patients with upper ureter and renal stones scheduled for flexible ureteroscope.

Exclusion criteria

  • Patients with associated distal ureteral stone, kidney transplant or any kind of urinary diversion.
  • Larger stones (11 cm) where the routine use of an access sheath will be felt appropriate to aid multiple passes of the scope.
  • Known ureteric strictures.
  • Concomitant ureteric stones.
  • Patients with narrow ureter where ureteral access sheath was anticipated to be difficult.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

84 participants in 2 patient groups

Flexible ureteroscope with ureteral access sheath
Experimental group
Description:
Stones will be treated by flexible ureteroscope with ureteral access sheath
Treatment:
Procedure: Flexible ureteroscope with ureteral access sheath
Flexible ureteroscope without ureteral access sheath
Active Comparator group
Description:
Stones will be treated by flexible ureteroscope without ureteral access sheath
Treatment:
Procedure: Flexible ureteroscope without ureteral access sheath

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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