| Registry | NCT07861815 |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 4 |
| Study type | Interventional; na, single group, masking: none, device feasibility |
| Enrollment | 20 (Estimated) |
| Sponsor | Chinese University of Hong Kong (Other) |
| Conditions | Colorectal Cancer, Colorectal Surgery, Ureteric Injury |
| Interventions | Intravenous Methylene Blue, Methylene Blue Fluorescence Imaging System (Drug, device) |
| Dates | start 2026-10-01 (estimated), primary completion 2027-10-01 (estimated), completion 2028-10-01 (estimated), first posted 2026-10-06, last updated 2026-10-06 |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Methylene Blue Fluorescence Imaging Arm | Experimental | Drug: Intravenous Methylene Blue; Device: Methylene Blue Fluorescence Imaging System | Intravenous Methylene Blue with Fluorescence Imaging for Ureter Identification |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * 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. Exclusion Criteria: * Unable to understand the aims and objectives of this study and unable to give consent for participation * Known allergy to methylene blue * Pregnant * 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 * Presence of renal or ureteric obstruction * History of G6PD deficiency (risk of hemolytic anemia)