Ureteric InjuryPhase 2NCT03177070
Fluorescent Imaging & Methylene Blue: Ureter Study
A Phase 2 study testing Methylene Blue in people with Ureteric Injury and Surgery, run by University of Oxford at 1 site in United Kingdom.
Trial summary
The main aim of this project is to assess whether intravenous methylene blue can help identify the ureters during open and laparoscopic (keyhole) surgery. The ureters are small tubes that link the kidney to the bladder and, if not properly identified during surgery, may be damaged. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ureteric Injury, Surgery, Surgery--Complications
- What is being tested?
- Methylene Blue
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 May 2016to 2 May 2017
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Patients undergoing laparoscopic or open colorectal surgery
- In the Investigator's opinion, is able and willing to comply with all study requirements.
Who cannot join
- The participant may not enter the study if ANY of the following apply:
- Patient who is unable or unwilling to give informed consent
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
- Significant renal or hepatic impairment.
- Any patients with previous allergies to Methylene Blue
- Any patients at risk of serotonin syndrome, including those taking serotonin reuptake inhibitors (SSRIs) or serotonin reuptake inhibitors (e.g. duloxetine, sibutramine, venlafaxine, clomipramine, imipramine)
- Patients with glucose-6-phosphate dehydrogenase (G6PD deficiency)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, OX3 9DS
About this study
Official title: Investigating the Use of Fluorescent Imaging and Methylene Blue to Identify and Prevent Ureteric Injuries During Laparoscopic and Open Colorectal Surgery
The main aim of this project is to assess whether intravenous methylene blue can help identify the ureters during open and laparoscopic (keyhole) surgery. The ureters are small tubes that link the kidney to the bladder and, if not properly identified during surgery, may be damaged.
Methylene blue has been safely given to patients for many years and it is fluorescent. It is removed by the kidney and will therefore travel through the ureters. Methylene blue shines brightly (becomes fluorescent) when viewed under red light.
Read more
This study aims to compare the ability of methylene blue with white light to identify the location of the ureters during colorectal surgery. Recruitment will include 50 patients undergoing colorectal surgery (25 for keyhole/laparoscopic, 25 for open procedures). Each patient will act as their own control.
To detect the fluorescence, a special fluorescent laparoscope for keyhole surgery will be utilised, and a wide-field camera will be used for open surgery.
The potential benefits of this procedure are to identify the ureters during surgery and therefore prevent inadvertent damage to them
It is hoped that near infra-red light emitting from the ureters will be detected. This will allow the surgeon to determine the anatomy of the ureters during the operation and avoid inadvertent injury.
Funding source: Nuffield Department of Surgical Sciences, University of Oxford Recruitment sites: Oxford University Hospitals NHS Trust.
- Conditions
- Ureteric Injury, Surgery, Surgery--Complications
- Being tested
- Methylene Blue
- Keywords
- Ureteric injury, Colorectal Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene BlueDrug
As described above. Intravenous injection with visualisation via fluorescence enabled laparoscope.
| Study group | Role | What they receive |
|---|---|---|
| Methylene Blue | Experimental | Intravenous administration of methylene blue and assessment of ureteric fluorescence intraoperatively. Receives: Drug: Methylene Blue |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the change in ureter identification over time using white light versus intravenous methylene blue in each patient.
Ureter identification with and without fluorescence.
Measured: This will be assessed at the following time points post methylene blue administration: 0 minutes; 5 minutes; 10 minutes; 20 minutes; 30 minutes; 40 minutes; 50 minutes; 60 minutes; 70 minutes; 80 minutes; 90 minutes; 100 minutes.
Secondary outcomes (1)
Fluorescence quantification following administration of methylene blue between dosing cohorts post methylene blue administration.
Fluorescence quantification is measured using signal to background ratio. Signal is assessed on images using software that determines the brightness of a selected area using the average intensity of Red, Green and Blue pixels.
Measured: This will be assessed at the following time points post methylene blue administration: 0 minutes; 5 minutes; 10 minutes; 20 minutes; 30 minutes; 40 minutes; 50 minutes; 60 minutes; 70 minutes; 80 minutes; 90 minutes; 100 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start9 May 2016
- Primary completion2 May 2017
- Study completion2 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteric InjuryStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Trevor Yeung, MBChB, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177070
- Sponsor's protocol ID
- 10871
- Status last verified
- Jun 2017
- First submitted
- 15 May 2017
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Use of Fluorescent Imaging and Methylene Blue to Identify and Prevent Ureteric Injuries During Laparoscopic and Open Colorectal Surgery
- ClinicalTrials.gov ID
- NCT03177070
- Acronym / sponsor ID
- 10871
- Conditions
- Ureteric Injury, Surgery, Surgery--Complications
- Keywords
- Ureteric injury, Colorectal Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 9 May 2016 (actual)
- Primary completion
- 2 May 2017 (actual)
- Study completion
- 2 May 2017 (actual)
- First posted
- 6 Jun 2017 (actual)
- 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.
The main aim of this project is to assess whether intravenous methylene blue can help identify the ureters during open and laparoscopic (keyhole) surgery. The ureters are small tubes that link the kidney to the bladder and, if not properly identified during surgery, may be damaged.
Methylene blue has been safely given to patients for many years and it is fluorescent. It is removed by the kidney and will therefore travel through the ureters. Methylene blue shines brightly (becomes fluorescent) when viewed under red light.
This study aims to compare the ability of methylene blue with white light to identify the location of the ureters during colorectal surgery. Recruitment will include 50 patients undergoing colorectal surgery (25 for keyhole/laparoscopic, 25 for open procedures). Each patient will act as their own control.
To detect the fluorescence, a special fluorescent laparoscope for keyhole surgery will be utilised, and a wide-field camera will be used for open surgery.
The potential benefits of this procedure are to identify the ureters during surgery and therefore prevent inadvertent damage to them
It is hoped that near infra-red light emitting from the ureters will be detected. This will allow the surgeon to determine the anatomy of the ureters during the operation and avoid inadvertent injury.
Funding source: Nuffield Department of Surgical Sciences, University of Oxford Recruitment sites: Oxford University Hospitals NHS Trust.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methylene Blue | Experimental | Drug: Methylene BlueIntravenous administration of methylene blue and assessment of ureteric fluorescence intraoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Patients undergoing laparoscopic or open colorectal surgery
- In the Investigator's opinion, is able and willing to comply with all study requirements.
Key exclusion criteria (7 listed)
- Patient who is unable or unwilling to give informed consent
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
- Significant renal or hepatic impairment.
- Any patients with previous allergies to Methylene Blue
- Any patients at risk of serotonin syndrome, including those taking serotonin reuptake inhibitors (SSRIs) or serotonin reuptake inhibitors (e.g. duloxetine, sibutramine, venlafaxine, clomipramine, imipramine)
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 |
|---|---|---|
| Methylene BlueAs described above. Intravenous injection with visualisation via fluorescence enabled laparoscope. | Drug | Methylene Blue |
Primary outcome
To compare the change in ureter identification over time using white light versus intravenous methylene blue in each patient.
Time frame: This will be assessed at the following time points post methylene blue administration: 0 minutes; 5 minutes; 10 minutes; 20 minutes; 30 minutes; 40 minutes; 50 minutes; 60 minutes; 70 minutes; 80 minutes; 90 minutes; 100 minutes.
Ureter identification with and without fluorescence.
1 secondary outcome
Fluorescence quantification following administration of methylene blue between dosing cohorts post methylene blue administration.
Time frame: This will be assessed at the following time points post methylene blue administration: 0 minutes; 5 minutes; 10 minutes; 20 minutes; 30 minutes; 40 minutes; 50 minutes; 60 minutes; 70 minutes; 80 minutes; 90 minutes; 100 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- Individual participant dataSharing planned: No. No plan to share IPD
Related trials for Ureteric Injury
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Assessing the Feasibility of Using Methylene Blue in Identifying Ureters During Colorectal Surgery
Colorectal Cancer, Colorectal Surgery
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Tissue Sensor for Semirigid Thulium Fiber Laser Ureterolithotripsy
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Active, not recruitingPhase 1
Evaluation of Lumitrace for Visualizing Ureters During Abdominopelvic Surgeries
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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.
Trevor Yeung, MBChB principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methylene Blue in people with Ureteric Injury and Surgery, run by University of Oxford at 1 site in United Kingdom.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To compare the change in ureter identification over time using white light versus intravenous methylene blue in each patient. (time frame: This will be assessed at the following time points post methylene blue administration: 0 minutes; 5 minutes; 10 minutes; 20 minutes; 30 minutes; 40 minutes; 50 minutes; 60 minutes; 70 minutes; 80 minutes; 90 minutes; 100 minutes.). 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 6 Jun 2017.