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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031220639
Enrollment
33
Registered
2023-02-15
Start date
2023-09-27
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

colorectal cancer

Interventions

Off-label use of indocyanine green for detecting sentinel lymph nodes during surgery of colorectal cancer
indocyanine green

Sponsors

Ishihara Soichiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Rate of subjects with resection line changed from baseline due to ICG fluorescence

Secondary

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

Contacts

Public ContactKoji Murono

The University of Tokyo Hospital

muronok-sur@h.u-tokyo.ac.jp+81-3-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026