Indocanine Green as Tracer for Lymph Nodes Dissection in Station 253

Last updated: April 16, 2021
Sponsor: Nanfang Hospital of Southern Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colon Cancer; Rectal Cancer

Colorectal Cancer

Colon Cancer

Treatment

N/A

Clinical Study ID

NCT04848311
NFEC-2021-073
  • Ages 18-80
  • All Genders

Study Summary

This is a prospective randomized controlled study. investigators will randomly assign patients to the indocanine green (ICG) group and control (CL)group to compare the differences of lymph nodes dissection in station 253 between the two groups.

Eligibility Criteria

Inclusion

Inclusion Criteria:

(1)18-80 years of age (2)American Society of Anesthesiologists (ASA) class 1-3 (3)singlerectal or sigmoid colon carcinoma confirmed pathologically by endoscopic biopsy (4)plannedlaparoscopic radical resection (5)Written informed consent

Exclusion

Exclusion Criteria:

  1. previous abdominal tumor surgery
  2. women who are pregnant or breast feeding
  3. emergency patients with obstruction or perforation
  4. T4b cancer evaluated by CT or MRI or endoscopic ultrasonography
  5. pelvic or distant metastasis
  6. T1 cancer planned local excision
  7. allergic constitution patients

Study Design

Total Participants: 66
Study Start date:
May 01, 2021
Estimated Completion Date:
May 01, 2022

Study Description

ICG is a registered and FDA-approved non-specific fluorescent probe for optical imaging in clinical settings. The properties of ICG ,which is a water-soluble amphiphilic molecule with a molecular weight of 775 Dalton and a hydrodynamic diameter of 1.2nm ,render it an excellent lymphatic contrast agents if injected into the lymphatic system. ICG near-infrared(NIR) fluorescent imaging has achieved satisfactory results in the localization of sentinel lymph nodes in patients with breast cancer,non-small cell lung cancer,and gastric cancer. Liang et al have suggested that 253 lymph nodes dissection in rectal cancer is technically demanding ,and that learning curve for laparoscopic 253 lymph nodes dissection requires minimally 20 procedures. Currently,it was still controversial about 253 lymph nodes dissection in rectal cancer surgery. However, lymph node involvement is a major prognostic factor for survival after rectal cancer surgery. Therefore, it is necessary to harvest more station 253 nodes for the better long-term survival and the more precise staging.

In this study, investigators will randomly assign patients to the indocanine green (ICG) group and control (CL)group. Number of harvested station 253 lymph nodes, number of positive station 253 lymph nodes, will be evaluated and compared. Investigators will also evaluate patients, operative time, blood loss, post-operative hospital stay and complications.

Connect with a study center

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong 510000
    China

    Active - Recruiting

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