Ureteral Reimplantation for the Treatment of Extrinsic Malignant Ureteral Obstruction
- Conditions
- Ureteral Obstruction
- Interventions
- Procedure: Laparoscopic ureteral re-implantation.
- Registration Number
- NCT02160652
- Lead Sponsor
- Rabin Medical Center
- Brief Summary
A single center single arm prospective study, assessing the outcome of ureteral re-implantation for malignant ureteral obstruction.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients Laparoscopic ureteral re-implantation. 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.
- Primary Outcome Measures
Name Time Method Ureteral patency - 6 months 6 months following the operation Ureteral patency at 6 months following the operation- assessed by stable or improved hydronephrosis and estimated GFR according to the CKD-EPI equation.
- Secondary Outcome Measures
Name Time Method Ureteral patency - 12 months 12 months following the operation Ureteral patency at 12 months following the operation.
Post-operative complications 1, 3, 6, and 12-months following the operation Post-operative complications 1, 3, 6, and12-months following the operation
Quality of life 1,3,6, and 12 months following the operation Changes in quality of life at 1,3, 6 and 12 months following the operation. Quality of life will be evaluated using two questionnaires:
* Functional Assessment of Cancer Therapy scale - General (FACT-G).
* Intervention specific questionnaire based on Joshi et al. ()Re-intervention 12 months following the operation Re-interventions following the operation.