Fluorescent Lymphography-Guided Lymphadenectomy In Laparoscopic Proctectomy

Fudan University

Status: Unknown

Conditions: Rectal Cancer

Treatments: Drug: Indocyanine Green

Study type: Interventional

Funder types: Other

Identifiers

NCT03854890

Fudan FLGI

Details and patient eligibility

About

The purpose of this study is to compare the number of lymph nodes retrieved with or without the use of intraoperative fluorescence lymphography in laparoscopic radical resection of rectal cancer.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed diagnosis of rectal carcinoma.
• Without multiple primary cancer.
• Without receiving neoadjuvant chemoradiotherapy.
• Sufficient organ function.
• Able to provide written informed consent.

Exclusion criteria

• Younger than 18 years or older than 75 years
• Synchronous or metachronous malignancy within 5 years.
• Patients with Intestinal obstruction or perforation or bleeding who require emergency surgery.
• Patients with a history of pelvic irradiation.
• ASA (American Society of Anesthesiologists) grade IV or V.
• Women who are pregnant (confirmed by serum β-Human Chorionic Gonadotropin in women of reproductive age) or breast feeding.
• Severe mental illness.
• Patients with severe emphysema, interstitial pneumonia, or ischemic heart disease who can not tolerate surgery.
• Patients who received steroid therapy within one month.
• Patients or family members misunderstand the conditions and goals of this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Lymphadenectomy without indocyanine green injection

No Intervention group

Description:

Laparoscopic lymphadenectomy will be performed in a standard way.

Lymphadenectomy with indocyanine green injection

Experimental group

Description:

Injection of indocyanine green to the submucosal layer around rectal cancer 1 day before surgery. Laparoscopic proctectomy with lymph nodes dissection will be performed under near-infrared imaging.

Treatment:

Drug: Indocyanine Green