Ureteral Reimplantation for the Treatment of Extrinsic Malignant Ureteral Obstruction

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

Study Overview

• Status: Unknown
• Conditions: Ureteral Obstruction
• Intervention / Treatment: Procedure: Laparoscopic ureteral re-implantation.

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 Type: Observational
• Enrollment (Anticipated): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ureteral patency - 12 months	Ureteral patency at 12 months following the operation.	12 months following the operation
Post-operative complications	Post-operative complications 1, 3, 6, and12-months following the operation	1, 3, 6, and 12-months following the operation
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
Re-intervention	Re-interventions following the operation.	12 months following the operation

Collaborators and Investigators

• Sponsor: Rabin Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: June 9, 2014
• First Submitted That Met QC Criteria: June 10, 2014
• First Posted (Estimate): June 11, 2014

Study Record Updates

• Last Update Posted (Actual): October 17, 2017
• Last Update Submitted That Met QC Criteria: October 15, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Ureteral Obstruction; HYDRONEPHROSIS; nephrostomy tube
• Additional Relevant MeSH Terms: Urologic Diseases; Ureteral Diseases; Ureteral Obstruction
• Other Study ID Numbers: 0185-14-RMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided