Long-term outcomes of paclitaxel-coated balloons for non-malignant ureteral strictures.
World J Urol
; 40(5): 1231-1238, 2022 May.
Article
en En
| MEDLINE
| ID: mdl-35246705
ABSTRACT
PURPOSE:
To evaluate the clinical efficacy and safety of drug-coated balloon (DCB) ureteroplasty for the management of non-malignant ureteral strictures. MATERIAL ANDMETHODS:
A prospective "off-label" monocentric single-arm pilot study investigating the safety and efficacy of drug-coated balloon (DCB) (Lutonix®; BD, USA) was performed. Twenty-five patients with benign ureteral strictures related to uretero-enteric anastomosis (n = 13); lithiasis (n = 5), post-surgical complications (iatrogenic n = 5), transplanted kidney (n = 1) and post-radiotherapy (n = 1) were included. Following lesion crossing, predilatation was performed using 4-7 mm high-pressure balloon catheter (5-6Fr) with a balloon pressure of 6-7 atm based on the manufacturer's recommendation. In the absence of rupture of the ureteral wall, the DCB was dilated for 4 min. across the lesion. The process was repeated if deemed necessary to a maximum of three stricture dilatations. We analysed both clinical and radiological primary patency (no signs of ipsilateral hydronephrosis or improvement of the existing residual dilatation at the follow-up examinations) and secondarily safety endpoints.RESULTS:
Mean lesion length was 40 ± 28.5 mm. Mean time follow up was 36 months ± 10.46 months. Strictures were located at upper ureteric (12%), lower ureteric (32%), ureterovesical anastomosis (4%) and uretero-enteric anastomosis (52%) levels. The overall radiological success at 1-year follow-up was 88% (22/25 patients). In 56% patients (14/25 patients with primary patency) the nephrostomy catheter was removed 21 days following a single DCB procedure. In 32% (8/25 patients) an additional dilatation sessions were required for maintaining the ureteral patency. The overall failure rate at 1-year follow-up was 12% (3/25 patients). Only one case of febrile urinary tract infection in a female patient (acute pyelonephritis) was encountered after the first dilatation.CONCLUSIONS:
Paclitaxel-coated balloon ureteroplasty proved to be safe and effective for the treatment of non-malignant ureteral strictures. Larger studies are warranted to validate these promising initial results.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Obstrucción Ureteral
/
Paclitaxel
Tipo de estudio:
Etiology_studies
/
Guideline
/
Observational_studies
Límite:
Female
/
Humans
/
Male
Idioma:
En
Revista:
World J Urol
Año:
2022
Tipo del documento:
Article
País de afiliación:
Grecia