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Ureteral Reimplantation for the Treatment of Extrinsic Malignant Ureteral Obstruction

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ClinicalTrials.gov Identifier: NCT02160652
Recruitment Status : Enrolling by invitation
First Posted : June 11, 2014
Last Update Posted : October 17, 2017
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

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

Condition or disease Intervention/treatment
Ureteral Obstruction 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.


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Ureteral Reimplantation for the Treatment of Extrinsic Malignant Ureteral Obstruction
Study Start Date : June 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Ureteral patency - 12 months [ Time Frame: 12 months following the operation ]
    Ureteral patency at 12 months following the operation.

  2. 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

  3. 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. ()

  4. Re-intervention [ Time Frame: 12 months following the operation ]
    Re-interventions following the operation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160652


Sponsors and Collaborators
Rabin Medical Center
Investigators
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Principal Investigator: David Margel, MD, PhD Rabin Medical Center

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Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02160652     History of Changes
Other Study ID Numbers: 0185-14-RMC
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Rabin Medical Center:
Ureteral Obstruction
HYDRONEPHROSIS
nephrostomy tube

Additional relevant MeSH terms:
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Ureteral Obstruction
Ureteral Diseases
Urologic Diseases