Ureteral Obstruction Clinical Trial
Official title:
Ureteral Reimplantation for the Treatment of Extrinsic Malignant Ureteral Obstruction
A single center single arm prospective study, assessing the outcome of ureteral re-implantation for malignant ureteral obstruction.
The Research Question: Is laparoscopic ureteral re-implantation, for the treatment of
malignant ureteral obstruction, associated with high patency rates, low complication rates,
and a significant improvement in quality of life?
Study design: A single center single arm prospective study, assessing the outcome of ureteral
re-implantation for malignant ureteral obstruction.
Study population: Patients with malignant ureteral obstruction, treated with laparoscopic
ureteral re-implantation, who have a life expectancy of over 6 months and are willing and
able to participate in the study.
Intervention: Laparoscopic ureteral re-implantation.
Study Time line: This will be a 1 year study. At initiation a baseline physical exam, blood
test, and ultrasonography will be performed. Baseline quality of life questionnaires will be
filled. After the operation, Follow-up visits will occur at 1, 3, 6 and 12 months after
surgery. At each follow up visit a medical history and physical examination, blood tests and
quality of life questionnaires will be performed. At 3, 6 and 12 months renal ultrasonography
will be performed.
Primary Endpoint: Ureteral patency at 6 months following treatment - assessed by stable or
improved hydronephrosis and estimated glomerular filtration rate (eGFR) according to the
Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
Study impact: Current treatments for malignant ureteral obstruction with nephrostomy tubes
negatively impact the patient's quality of life. The findings of the current study may
support the use of laparoscopic ureteral re-implantation for the treatment of malignant
ureteral obstruction, if patency is preserved, and quality of life is improved, following the
procedure.
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|---|---|---|---|
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