NCT07861815Not yet recruitingPhase 4
Assessing the Feasibility of Using Methylene Blue in Identifying Ureters During Colorectal Surgery
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
This study will assess whether methylene blue fluorescence imaging can help surgeons identify the ureters during colorectal surgery. Methylene blue, given through a vein during the operation, is taken up and excreted by the kidneys, allowing the ureters to appear under a special fluorescence camera system. The study will include adults undergoing open, laparoscopic, or robotic colorectal surgery at Prince of Wales Hospital. The surgeons will compare ureter visibility using standard white light with visibility using fluorescence imaging at different stages of the operation. The study will also assess the best dose of methylene blue, the additional time required, the ease of using the imaging system, and whether the imaging findings affect the surgical plan. The study's hypothesis is that methylene blue fluorescence imaging will make it easier or faster to identify the ureters than white light alone. The technique will be considered feasible if it is helpful in at least 20% of operations-for example, by identifying a ureter earlier or identifying it when it cannot be seen under white light. The findings will help determine whether a larger future study should be conducted.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 1 Oct 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 1 Oct 2027
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Colorectal cancer
- NCT number
- NCT07861815
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 20
- From 1 Oct 2026 to the primary completion date, 1 Oct 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known allergy to methylene blue
- Taking selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, monoamine oxidase inhibitors, or tricyclic antidepressants (risk of serotonin syndrome)
- Significant renal or hepatic impairment
- History of G6PD deficiency (risk of hemolytic anemia)
Other
- Unable to understand the aims and objectives of this study and unable to give consent for participation
- Pregnant
- Presence of renal or ureteric obstruction
Who the study is looking for
- Aged ≥18 years
- Scheduled to undergo open, laparoscopic or robotic colorectal surgery, including right colectomy, extended right colectomy, left colectomy, high anterior resection, low anterior resection, abdominoperineal resection, subtotal colectomy and total colectomy.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.