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

JRCT ID: jRCTs071240077

Registered date:21/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Rectal cancer
• Date of first enrollment: 21/11/2024
• Target sample size: 45
• Study type: Interventional
• Intervention(s): Indocyanine green injection into the ventral rectal mucosa of rectal cancer lesions

Outcome(s)

• Primary Outcome: Visibility of lesion marking using fluorescent scoring
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 85age old
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Nonaka Takashi