Fluorescent Imaging & Methylene Blue: Ureter Study
|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: NCT03177070|
Recruitment Status : Completed
First Posted : June 6, 2017
Last Update Posted : June 6, 2017
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
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
|Oxford University Hospitals NHS Foundation Trust|
|Oxford, Oxfordshire, United Kingdom, OX3 9DS|
|Principal Investigator:||Trevor Yeung, MBChB||University of Oxford|