Exploratory study on lymphatic flow identification using ICG fluorescence imaging for pancreatic tumor patients

JRCT ID: jRCTs031230716

Registered date:19/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pancreatic tumor
• Date of first enrollment: 26/03/2024
• Target sample size: 20
• Study type: Interventional

Intervention(s)

1. Dilute ICG 1 ampoule (25 mg) to 2.5 mg/mL with 10 mL of water for injection in the Japanese Pharmacopoeia.
2. Immediately after the start of surgery, the basic dose of diluted ICG is 0.1 mL (equivalent to 0.25 mg of ICG), but if the dose is expected to be small based on body weight, etc., 0.2 mL (equivalent to 0.50 mg of ICG) is acceptable. It is injected locally into the pancreatic parenchyma on the cephalocaudal and right and left sides of the tumor, using a 25G needle for endoscopy, at a total of 4 sites approximately 5 mm from the tumor margin. Areas where local injection is difficult due to tumor localization etc. may be omitted.
3. After local injection, near-infrared observation is performed every 15 minutes to check for lymphatic flow.
If visualization cannot be confirmed 1 hour after local injection, observe the specimen every 30 minutes until and at the time of specimen removal. If lymphatic flow delineation cannot be confirmed by the time the specimen is removed, lymphatic flow identification is determined to be impossible.
4. If a lymph node is found to be positive for ICG fluorescence, place the lymph node in a formalin container separate from other dissected lymph nodes and submit it for pathological examination to confirm the presence or absence of histopathological metastasis.

Outcome(s)

• Primary Outcome: Identification rate of lymphatic flow

Secondary Outcome

1. Time required from ICG local injection to confirmation of lymphatic flow.
2. Number of ICG fluorescence positive lymph nodes.
3. Histopathological presence or absence of metastasis in ICG fluorescence-positive lymph nodes.
4. Frequency and incidence of adverse events .

Key inclusion & exclusion criteria

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

Include criteria

1. Patients diagnosed with malignant or borderline malignant pancreatic tumor based on image findings, etc.
2. Patients undergoing robotic or laparoscopic pancreaticoduodenectomy or distal pancreatectomy.
3. Patients aged 18 years or older at the time of informed consent.
4. Patients who have given their written informed consent.

Exclude criteria

1. Patients with a history of allergy to indocyanine green or iodinated contrast agents.
2. Patients with a history of gastric surgery or right-sided colon surgery (excluding appendectomy).
3. Patients who are pregnant, may be pregnant, or are lactating.
4. Patients who are judged as ineligible for registration by attending doctors.

Related Information

• Primary Sponsor: Ishikawa Yoshiya