Ureteral Reimplantation for the Treatment of Extrinsic Malignant Ureteral Obstruction

Ureteral Obstruction Clinical Trial

Official title:

Ureteral Reimplantation for the Treatment of Extrinsic Malignant Ureteral Obstruction

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02160652
• Other study ID #: 0185-14-RMC
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 9, 2014
• Last updated: October 15, 2017
• Start date: June 2014
• Est. completion date: June 2018

Study information

• Verified date: October 2017
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A single center single arm prospective study, assessing the outcome of ureteral re-implantation for malignant ureteral obstruction.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ureteral Obstruction

Intervention

Procedure:
• Laparoscopic ureteral re-implantation.
Laparoscopic ureteral re-implantation for the treatment of malignant ureteral obstruction.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ureteral patency - 6 months	Ureteral patency at 6 months following the operation- assessed by stable or improved hydronephrosis and estimated GFR according to the CKD-EPI equation.	6 months following the operation
Secondary	Ureteral patency - 12 months	Ureteral patency at 12 months following the operation.	12 months following the operation
Secondary	Post-operative complications	Post-operative complications 1, 3, 6, and12-months following the operation	1, 3, 6, and 12-months following the operation
Secondary	Quality of life	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. ()	1,3,6, and 12 months following the operation
Secondary	Re-intervention	Re-interventions following the operation.	12 months following the operation