NCT02160652

Ureteral Reimplantation for the Treatment of Extrinsic Malignant Ureteral Obstruction

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ureteral Obstruction

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic ureteral re-implantation.	Laparoscopic ureteral re-implantation for the treatment of malignant ureteral obstruction.

Timeline

• Start date: 2014-06-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2014-06-11
• Last updated: 2017-10-17