Fluorescent Lymphography-Guided Lymphadenectomy In Laparoscopic Proctectomy

Overview

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.

Full Title of Study: “Fluorescent Lymphography-Guided Lymphadenectomy Using Indocyanine Green During Laparoscopic Radical Resection Of Rectal Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 1, 2020

Interventions

  • Drug: Indocyanine Green
    • Indocyanine Green will be injected to the submucosal layer around the lesion one day before surgery.

Arms, Groups and Cohorts

  • No Intervention: Lymphadenectomy without indocyanine green injection
    • Laparoscopic lymphadenectomy will be performed in a standard way.
  • Experimental: Lymphadenectomy with indocyanine green injection
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • The total number of lymph nodes retrieved
    • Time Frame: During the surgery
  • The positive number of lymph nodes retrieved
    • Time Frame: During the surgery

Secondary Measures

  • The duration of the operation to remove the lymph nodes
    • Time Frame: During the surgery
  • Detection rate of indocyanine green-positive para-aortic lymph node
    • Time Frame: During the surgery

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fudan University
  • Provider of Information About this Clinical Study
    • Principal Investigator: LI XIN-XIANG, Professor – Fudan University
  • Overall Contact(s)
    • Xinxiang Li, MD,PhD, +8613761291659, lxx1149@163.com

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