A Study to Evaluate the Efficacy and Safety of Local administration of Indocyanine Green in Surgery for Colorectal Neoplasm

JRCT ID: jRCTs031220639

Registered date:15/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: colorectal cancer
• Date of first enrollment: 27/09/2023
• Target sample size: 33
• Study type: Interventional
• Intervention(s): Off-label use of indocyanine green for detecting sentinel lymph nodes during surgery of colorectal cancer

Outcome(s)

• Primary Outcome: Rate of subjects with resection line changed from baseline due to ICG fluorescence

Secondary Outcome

(1) The lymph flow detected during surgery
(2) The number of lymph nodes resected during surgery
(3) Incidence of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) With a histological diagnosis of colorectal cancer
(2) Scheduled to have any surgery for the colorectal cancer
(3) With an ECOG performance status of 0 or 1
(4) Aged 18 years and above at the time of informed consent is taken
(5) Male or female
(6) Able and willing to give written informed consent with sufficient understanding after having received sufficient explanation

Exclude criteria

(1) With allergy to indocyanine green
(2) With iodine allergy or with allergy to iodine contrast
(3) With severe liver failure, renal failure, or cardiac disease
(4) With bowel obstruction
(5) With intraperitoneal infection (e.g. peritonitis or intraperitoneal abscesses)
(6) Difficult colonoscopy
(7) Having a history of severe drug allergy or severe side effects
(8) Pregnant, unwilling to practice contraception during the study, or lactating female
(9) Judged as ineligible by clinical investigators

Related Information

• Primary Sponsor: Ishihara Soichiro