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Ureteral Reimplantation for the Treatment of Extrinsic Malignant Ureteral Obstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02160652
Recruitment Status : Unknown
Verified October 2017 by Rabin Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : June 11, 2014
Last Update Posted : October 17, 2017
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

Tracking Information
First Submitted Date June 9, 2014
First Posted Date June 11, 2014
Last Update Posted Date October 17, 2017
Study Start Date June 2014
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 10, 2014)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 10, 2014)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ureteral Reimplantation for the Treatment of Extrinsic Malignant Ureteral Obstruction
Official Title Ureteral Reimplantation for the Treatment of Extrinsic Malignant Ureteral Obstruction
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Ureteral Obstruction
Intervention Procedure: Laparoscopic ureteral re-implantation.
Laparoscopic ureteral re-implantation for the treatment of malignant ureteral obstruction.
Study Groups/Cohorts 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.
Intervention: Procedure: Laparoscopic ureteral re-implantation.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 10, 2014)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2018
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02160652
Other Study ID Numbers 0185-14-RMC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Rabin Medical Center
Study Sponsor Rabin Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: David Margel, MD, PhD Rabin Medical Center
PRS Account Rabin Medical Center
Verification Date October 2017