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Fluorescent Imaging & Methylene Blue: Ureter Study

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ClinicalTrials.gov Identifier: NCT03177070
Recruitment Status : Completed
First Posted : June 6, 2017
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Ureteric Injury Surgery Surgery--Complications Drug: Methylene Blue Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Investigating the Use of Fluorescent Imaging and Methylene Blue to Identify and Prevent Ureteric Injuries During Laparoscopic and Open Colorectal Surgery
Actual Study Start Date : May 9, 2016
Actual Primary Completion Date : May 2, 2017
Actual Study Completion Date : May 2, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Methylene Blue
Intravenous administration of methylene blue and assessment of ureteric fluorescence intraoperatively.
Drug: Methylene Blue
As described above. Intravenous injection with visualisation via fluorescence enabled laparoscope.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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)

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): NCT03177070


Locations
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United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, United Kingdom, OX3 9DS
Sponsors and Collaborators
University of Oxford
Investigators
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Principal Investigator: Trevor Yeung, MBChB University of Oxford
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT03177070    
Other Study ID Numbers: 10871
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oxford:
Ureteric injury
Colorectal Surgery
Additional relevant MeSH terms:
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Wounds and Injuries
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action