Ureteral Reimplantation for the Treatment of Extrinsic Malignant Ureteral Obstruction
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|ClinicalTrials.gov Identifier: NCT02160652|
Recruitment Status : Enrolling by invitation
First Posted : June 11, 2014
Last Update Posted : October 17, 2017
|Condition or disease||Intervention/treatment|
|Ureteral Obstruction||Procedure: Laparoscopic ureteral re-implantation.|
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 Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Ureteral Reimplantation for the Treatment of Extrinsic Malignant Ureteral Obstruction|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
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.
- Ureteral patency - 6 months [ Time Frame: 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.
- Ureteral patency - 12 months [ Time Frame: 12 months following the operation ]Ureteral patency at 12 months following the operation.
- Post-operative complications [ Time Frame: 1, 3, 6, and 12-months following the operation ]Post-operative complications 1, 3, 6, and12-months following the operation
- Quality of life [ Time Frame: 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 [ Time Frame: 12 months following the operation ]Re-interventions following the operation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160652
|Principal Investigator:||David Margel, MD, PhD||Rabin Medical Center|