Ureteral Reimplantation for the Treatment of Extrinsic Malignant Ureteral Obstruction
Study Details
Study Description
Brief Summary
A single center single arm prospective study, assessing the outcome of ureteral re-implantation for malignant ureteral obstruction.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients 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. |
Procedure: Laparoscopic ureteral re-implantation.
Laparoscopic ureteral re-implantation for the treatment of malignant ureteral obstruction.
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Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion criteria:
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Adult patient, older than 18 years of age.
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Patient with malignant ureteral obstruction diagnosed by creatinine elevation with evidence of ureteral obstruction on imaging.
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Patient is scheduled for ureteral reimplantation due to extrinsic malignant ureteral obstruction.
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American Society of Anesthesiologist score ≤3, enabling the patient to undergo surgery.
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Life expectancy of over 6 months ( see exclusion criteria for definition)
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WHO performance status 0-2
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The patient is willing and able to read, understand and sign the study specific informed consent form
Exclusion criteria:
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Patients who underwent urinary diversion other than percutaneous nephrostomy or retrograde ureteral stenting prior to the planned treatment.
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Patients unable to sign an informed consent for or unwilling to undergo so.
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Life expectancy of less than 6 months, as defined according to the criteria by Ishioka et al. and predicted in the presence of:
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Low serum albumin before percutaneous nephrostomy/ retrograde ureteral stenting (3 gm/dl or less).
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Low grade hydronephrosis prior to percutaneous nephrostomy/ retrograde ureteral stenting placement (grade 1 or 2) as graded by the grading system of the Society for Fetal Urology
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Malignant ascites or malignant pleural effusion.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Rabin Medical Center
Investigators
- Principal Investigator: David Margel, MD, PhD, Rabin Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0185-14-RMC