Fluorescent Imaging & Methylene Blue: Ureter Study

NCT03177070 | Completed Phase 2

• 1 other identifier: 10871
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Ureteric Injury; Surgery; Surgery--Complications

Keywords

Ureteric injury; Colorectal Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

Study Arms (1)

Methylene Blue

EXPERIMENTAL

Intravenous administration of methylene blue and assessment of ureteric fluorescence intraoperatively.

Drug: Methylene Blue

Interventions

Methylene Blue DRUG

As described above. Intravenous injection with visualisation via fluorescence enabled laparoscope.

Methylene Blue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, OX3 9DS, United Kingdom

Location

MeSH Terms

Interventions

Methylene Blue

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Trevor Yeung, MBChB

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: June 6, 2017
• Study Start: May 9, 2016
• Primary Completion: May 2, 2017
• Study Completion: May 2, 2017
• Last Updated: June 6, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)