Clinical trial NCT02160652: Ureteral Reimplantation for the Treatment of Extrinsic Malignant Ureteral Obstruction
Official title: Ureteral Reimplantation for the Treatment of Extrinsic Malignant Ureteral Obstruction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ureteral Obstruction
Keywords: Ureteral Obstruction
HYDRONEPHROSIS
nephrostomy tube
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2014-06-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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

Exclusion criteria:

1. Patients who underwent urinary diversion other than percutaneous nephrostomy or retrograde ureteral stenting prior to the planned treatment.
2. Patients unable to sign an informed consent for or unwilling to undergo so.
3. Life expectancy of less than 6 months, as defined according to the criteria by Ishioka et al. and predicted in the presence of:

   * Low serum albumin before percutaneous nephrostomy/ retrograde ureteral stenting (3 gm/dl or less).
   * 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
   * Malignant ascites or malignant pleural effusion.

Primary outcomes:
measure: Ureteral patency - 6 months
timeFrame: 6 months following the operation
Secondary outcomes:
measure: Ureteral patency - 12 months
timeFrame: 12 months following the operation
measure: Post-operative complications
timeFrame: 1, 3, 6, and 12-months following the operation
measure: Quality of life
timeFrame: 1,3,6, and 12 months following the operation
measure: Re-intervention
timeFrame: 12 months following the operation
Other outcomes:
Locations:
Study officials:
affiliation: Rabin Medical Center
name: David Margel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: