Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05992363 |
| Other study ID # |
0100-23-RMC |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
October 2023 |
| Est. completion date |
December 2026 |
Study information
| Verified date |
August 2023 |
| Source |
Rabin Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Malignant ureteral obstruction (MUO) is an extrinsic ureteral obstruction caused by malignant
diseases. This study aim to compare tandem 6 Fr Percuflex™ stents and single large-caliber
8Fr silicone stent in patients with MUO. The primary endpoint is stent failure rate. The
secondary endpoints are patient comfort, quality of life and overall survival.
Description:
Malignant ureteral obstruction (MUO) is an extrinsic ureteral obstruction caused by malignant
diseases. MUO may induce renal failure, which would be a barrier to several therapies
including chemotherapy. Indwelling double-pigtail polymeric ureteral stent is a common method
to release renal obstruction, but does not necessarily guarantee renal decompression as most
studies reported stent failure with a mean of 30% at a mean time of three months [1-3].
Various endoscopic strategies have been proposed to increase time to failure, including
tandem polymeric stents, metallic spiral coil stent, self-expanding Nitinol stent and
polymeric stents with different lumen diameter and stiffness [4-7]. However, heterogeneity of
MUO, low number of patients, unspecified polymer type, retrospective studies and the lack of
a standard method to assess stent failure limit robust comparative analysis.
Tandem ureteral stents (TUS) technique uses two polymeric ureteral stents passed
simultaneously to better withstand the presumed compressive forces that overcome conventional
single stent. This method offers an additional parallel lumen and allows more extraluminal
flow between the two stents [6].
In a study on TUS in 39 renal units with MUO, two 6 Fr stents were inserted. Stent failure,
defined by flank pain with increasing creatinine level or worsening hydronephrosis during 3
months after stents insertion, was occurred in 4% of cases [7]. This low failure rate
compares favorably with the reported rates with single 6Fr polymeric stent or metallic stent.
However, stents irritation, defined by profound lower urinary tract symptoms or renal colic
in the absence of worsening hydronephrosis or infection, was reported in 29-85% of patients
[7,8].
Silicon stent, which is considered biocompatible and soft, has the potential to be less
irritative. In a recent systematic review, silicone stents has less stent-related symptoms in
comparison to non-silicone polymers and ''hard'' stents. [9]. However, silicone has high
susceptibility to compression, which in case of MUO may results in lower drainage efficacy.
This study aim to compare tandem 6 Fr Percuflex™ stents and single large-caliber 8Fr silicone
stent in patients with MUO. The primary endpoint is stent failure rate. The secondary
endpoints are patient comfort, quality of life and overall survival.
References:
1. Docimo SG, Dewolf WC. High failure rate of indwelling ureteral stents in patients with
extrinsic obstruction: experience at 2 institutions. J Urol. 1989;142(2 Pt 1):277-279.
doi:10.1016/s0022-5347(17)38729-3
2. Vogt B, Blanchet LH. Analysis of Ureteral Tumour Stents for Malignant Ureteral
Obstruction: Towards Reshaping an Optimal Stent. Res Rep Urol. 2021;13:773-782.
Published 2021 Oct 27. doi:10.2147/RRU.S334277
3. Chung SY, Stein RJ, Landsittel D, et al. 15-year experience with the management of
extrinsic ureteral obstruction with indwelling ureteral stents. J Urol.
2004;172(2):592-595. doi:10.1097/01.ju.0000130510.28768.f5
4. Patel C, Loughran D, Jones R, Abdulmajed M, Shergill I. The resonance® metallic ureteric
stent in the treatment of chronic ureteric obstruction: a safety and efficacy analysis
from a contemporary clinical series. BMC Urol. 2017;17(1):16. Published 2017 Mar 10.
doi:10.1186/s12894-017-0204-8
5. Khoo CC, Ho C, Palaniappan V, et al. Single-Center Experience with Three Metallic
Ureteral Stents (Allium® URS, Memokath™-051, and Resonance®) for Chronic Ureteral
Obstruction. J Endourol. 2021;35(12):1829-1837. doi:10.1089/end.2021.0208
6. Fromer DL, Shabsigh A, Benson MC, Gupta M. Simultaneous multiple double pigtail stents
for malignant ureteral obstruction. Urology. 2002;59(4):594-596.
doi:10.1016/s0090-4295(01)01646-7
7. Elsamra SE, Motato H, Moreira DM, et al. Tandem ureteral stents for the decompression of
malignant and benign obstructive uropathy. J Endourol. 2013;27(10):1297-1302.
doi:10.1089/end.2013.0281
8. Shvero A, Haifler M, Mahmud H, Dotan Z, Winkler H, Kleinmann N. Quality of life with
tandem ureteral stents compared to percutaneous nephrostomy for malignant ureteral
obstruction. Support Care Cancer. 2022;30(11):9541-9548. doi:10.1007/s00520-022-07354-2
9. Boeykens M, Keller EX, Bosio A, et al. Impact of Ureteral Stent Material on
Stent-related Symptoms: A Systematic Review of the Literature. Eur Urol Open Sci.
2022;45:108-117. Published 2022 Oct 19. doi:10.1016/j.euros.2022.09.005
