Ureteral Obstruction
Conditions
Keywords
Ureteral Obstruction, HYDRONEPHROSIS, nephrostomy tube
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.
Interventions
PROCEDURELaparoscopic ureteral re-implantation.
Laparoscopic ureteral re-implantation for the treatment of malignant ureteral obstruction.
Sponsors
Rabin Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patient, older than 18 years of age. 2. Patient with malignant ureteral obstruction diagnosed by creatinine elevation with evidence of ureteral obstruction on imaging. 3. Patient is scheduled for ureteral reimplantation due to extrinsic malignant ureteral obstruction. 4. American Society of Anesthesiologist score ≤3, enabling the patient to undergo surgery. 5. Life expectancy of over 6 months ( see
Exclusion criteria
for definition) 6. WHO performance status 0-2 7. The patient is willing and able to read, understand and sign the study specific informed consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed