Intra-operative fluorescent imaging of the tumor border and sentinel lymph nodes in rectal and sigmoid cancer

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27686

Enrollment

Registered

2014-07-08

Start date

2013-10-28

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel cancer

Interventions

After general anesthesia, prior to incision, ICG

NanoColl will be injected endoscopically around the tumor. During surgery, fluorescence imaging will be performed to visualize tumor border and lymph nodes.

Eligibility

Inclusion criteria

Inclusion criteria: Colorectal cancer patients scheduled for laparoscopic low anterior resection.

Exclusion criteria

Exclusion criteria: 1. History of allergy to iodine, shellfish, indocyanine green or nanocolloid; 2. Pregnancy; 3. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

Design outcomes

Primary

Measure	Time frame
1. Percentage of patients in whom SLN identification was possible using NIR fluorescence imaging 2. Percentage of patients in whom intraopertive detection of the tumor border was possible by NIR fluorescence imaging	—

Secondary

Measure	Time frame
Time difference between visualization of fluorescence signal and Indian ink tattoo. Sensitivity of SLN procedure.	—

Contacts

Public ContactC.J.H. Velde, van de

Leiden University Medical Center (LUMC), Department of Surgical Oncology, P.O. Box 9600

c.j.h.van_de_velde@lumc.nl+31 (0)71 5262309

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)