Ureteral ObstructionNCT02160652
Ureteral Reimplantation for the Treatment of Extrinsic Malignant Ureteral Obstruction
An observational study of Ureteral Obstruction, run by Rabin Medical Center.
Trial summary
A single center single arm prospective study, assessing the outcome of ureteral re-implantation for malignant ureteral obstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureteral Obstruction
- What is being tested?
- Laparoscopic ureteral re-implantation.
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult patient, older than 18 years of age.
- Patient with malignant ureteral obstruction diagnosed by creatinine elevation with evidence of ureteral obstruction on imaging.
- Patient is scheduled for ureteral reimplantation due to extrinsic malignant ureteral obstruction.
- American Society of Anesthesiologist score ≤3, enabling the patient to undergo surgery.
- Life expectancy of over 6 months ( see exclusion criteria for definition)
- WHO performance status 0-2
- The patient is willing and able to read, understand and sign the study specific informed consent form
Who cannot join
- Patients who underwent urinary diversion other than percutaneous nephrostomy or retrograde ureteral stenting prior to the planned treatment.
- Patients unable to sign an informed consent for or unwilling to undergo so.
- 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.
About this study
A single center single arm prospective study, assessing the outcome of ureteral re-implantation for malignant ureteral obstruction.
Read the 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.
- Conditions
- Ureteral Obstruction
- Being tested
- Laparoscopic ureteral re-implantation.
- Keywords
- Ureteral Obstruction, HYDRONEPHROSIS, nephrostomy tube
- Medical subject headings
- Ureteral Obstruction, Hydronephrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic ureteral re-implantation.Procedure or surgery
Laparoscopic ureteral re-implantation for the treatment of malignant ureteral obstruction.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Laparoscopic ureteral re-implantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months following the operation
Secondary outcomes (4)
Ureteral patency - 12 months
Ureteral patency at 12 months following the operation.
Measured: 12 months following the operation
Post-operative complications
Post-operative complications 1, 3, 6, and12-months following the operation
Measured: 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. ()
Measured: 1,3,6, and 12 months following the operation
Re-intervention
Re-interventions following the operation.
Measured: 12 months following the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Margel, MD, PhD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160652
- Sponsor's protocol ID
- 0185-14-RMC
- Status last verified
- Oct 2017
- First submitted
- 9 Jun 2014
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ureteral Reimplantation for the Treatment of Extrinsic Malignant Ureteral Obstruction
- ClinicalTrials.gov ID
- NCT02160652
- Acronym / sponsor ID
- 0185-14-RMC
- Conditions
- Ureteral Obstruction
- Keywords
- Ureteral Obstruction, HYDRONEPHROSIS, nephrostomy tube
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 11 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Procedure: Laparoscopic ureteral re-implantation.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Adult patient, older than 18 years of age.
- Patient with malignant ureteral obstruction diagnosed by creatinine elevation with evidence of ureteral obstruction on imaging.
- Patient is scheduled for ureteral reimplantation due to extrinsic malignant ureteral obstruction.
- American Society of Anesthesiologist score ≤3, enabling the patient to undergo surgery.
- Life expectancy of over 6 months ( see exclusion criteria for definition)
Key exclusion criteria (6 listed)
- Patients who underwent urinary diversion other than percutaneous nephrostomy or retrograde ureteral stenting prior to the planned treatment.
- Patients unable to sign an informed consent for or unwilling to undergo so.
- Life expectancy of less than 6 months, as defined according to the criteria by Ishioka et al. and predicted in the presence of:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic ureteral re-implantation.Laparoscopic ureteral re-implantation for the treatment of malignant ureteral obstruction. | Procedure or surgery | Patients |
Primary outcome
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.
4 secondary outcomes
Ureteral patency - 12 months
Time frame: 12 months following the operation
Post-operative complications
Time frame: 1, 3, 6, and 12-months following the operation
Quality of life
Time frame: 1,3,6, and 12 months following the operation
Re-intervention
Time frame: 12 months following the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Margel, MD, PhD principal investigator
Rabin Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Ureteral Obstruction, run by Rabin Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ureteral patency - 6 months (time frame: 6 months following the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2017.