Placement of a double-J catheter transurethral via the urinary bladder versus transcutaneous via the kidney in patients with extrinsic obstruction of the ureter.
- Conditions
- Extrinsieke ureter obstructieExtrinsic ureter obstruction
- Registration Number
- NL-OMON25446
- Lead Sponsor
- Dr. H. van OverhagenHaga ZiekienhuisLeyweg 2752545 CH Den Haag070-2100000h.voverhagen@hagaziekenhuis.nl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 214
Inclusion Criteria
• Legally capable and written informed consent
• 18 years or older
• A CT or MRI diagnosis of extrinsic ureter obstruction by visible or non-visible mass surrounding the urinary tract
• Possible dorsal percutaneous approach to kidney
• Possible transvesical approach
• Possible treatment by an urologist and intervention radiologist with sufficient experience
• Patient is willing and able to comply with the specified follow-up evaluation
Exclusion Criteria
• Active infection, defined as temperature >38,0 °C
• Macroscopic haematuria
• INR > 2,0
• Thrombocytes < 50 109/l
• Ileal conduit urinary diversion
• Kidney transplantation
• Horseshoe kidney
• Known allergy to contrast media
• Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immediate technical success rate
- Secondary Outcome Measures
Name Time Method • To compare VAS scores after retrograde and antegrade stent insertion in patients with extrinsic urinary tract obstruction.<br>• To compare the complications after retrograde and antegrade stent insertion in patients with extrinsic urinary tract obstruction.<br>• To compare technical success rates at 30 days after retrograde and antegrade stent insertion in patients with extrinsic urinary tract obstruction.<br>• To compare scores on EQ5D questionnaire at 30 days after retrograde and antegrade stent insertion in patients with extrinsic urinary tract obstruction.<br>• To assess possible predictive factors for immediate technical success.<br>• To assess possible predictive factors for technical success at 30 days.<br>• To assess possible predictive factors for the evolvement of major and minor complications.<br>• To assess possible predictive factors for the outcome on the EQ5D questionnaire.<br>