Fluorescent Lymphography-Guided Lymphadenectomy In Laparoscopic Proctectomy

Study Overview
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Brief Summary
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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.

Official Title
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Fluorescent Lymphography-Guided Lymphadenectomy Using Indocyanine Green During Laparoscopic Radical Resection Of Rectal Cancer

Conditions
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Rectal Cancer

Intervention / Treatment
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* Drug: Indocyanine Green


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Lymphadenectomy without indocyanine green injection<br>Laparoscopic lymphadenectomy will be performed in a standard way. | |
| Experimental: Lymphadenectomy with indocyanine green injection<br>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. | Drug: Indocyanine Green<br>* Indocyanine Green will be injected to the submucosal layer around the lesion one day before surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total number of lymph nodes retrieved |  | During the surgery | 
| The positive number of lymph nodes retrieved |  | During the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration of the operation to remove the lymph nodes |  | During the surgery | 
| Detection rate of indocyanine green-positive para-aortic lymph node |  | During the surgery |