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Utility and safety of preoperative lesion marking using ICGin robotic-assisted rectal cancer surgery

Utility and safety of preoperative lesion marking using indocyanine green (ICG) in robotic-assisted rectal cancer surgery

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs071240077
Enrollment
45
Registered
2024-11-21
Start date
2024-11-21
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

Rectal cancer

Interventions

Indocyanine green injection into the ventral rectal mucosa of rectal cancer lesions

Sponsors

Nonaka Takashi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.The primary rectal lesion has been histologically diagnosed as adenocarcinoma. 2.The disease has been diagnosed as clinical stage cStage I-III. 3. Age at the time of registration is 18 years or older and 85 years or younger, regardless of gender. 4.Patients have a general condition and organ function that allows surgery. 5. Performance Status (ECOG) is either 0 or 1.

Exclusion criteria

Exclusion criteria: 1. Patients who requested laparotomy after preoperative explanation 2. Patients with the following serious complications i) Poorly controlled diabetes ii) Poorly controlled hypertension iii) Interstitial pneumonia, pulmonary fibrosis, severe emphysema 3. Patients with iodine allergies 4. Women who are pregnant, may be pregnant, within 28 days of giving birth, or breastfeeding 5. Patients who are deemed to have difficulty participating in the study due to psychiatric illness or psychiatric symptoms 6. Other cases that the principal investigator or co-investigator judges to be inappropriate

Design outcomes

Primary

MeasureTime frame
Visibility of lesion marking using fluorescent scoring

Secondary

MeasureTime frame
Recognition rate of the marked area, the presence or absence of complications during ICG injection, the rate of side effects after ICG administration, operation time, blood loss, postoperative complications, and length of hospital stay after surgery

Contacts

Public ContactTakashi Nonaka

Nagasaki University Hospital

tnonaka@nagasaki-u.ac.jp+81-95-819-7304

Outcome results

None listed

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