Applications of Fluorescence Imaging Guided Lymph Node Dissection and Fluorescence Angiography of Inferior Mesenteric Artery Assisted Left Colic Artery Preservation

Last updated: September 10, 2023
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colic

Treatment

Fluorescence laparoscopic system

Clinical Study ID

NCT06033794
NCC-4123
  • Ages 18-75
  • All Genders

Study Summary

To investigate the accuracy of fluorescence angiography technique IMA classification and the impact of lymph node mapping technique on the dissection of No. 253 lymph nodes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients aged between 18 and 75 years
  • Colonoscopic biopsy confirmed colorectal adenocarcinoma
  • The tumor was located in the rectum or upper rectum, and the surgical method was Dxion
  • No local complications before operation (no obstruction, incomplete obstruction, nomassive active bleeding, no perforation, abscess formation, no local invasion)
  • Preoperative imaging diagnosis was cT1-4aNxM0
  • The hematopoietic functions of heart, lung, liver, kidney and bone marrow meet therequirements of surgery and anesthesia
  • Sign the informed consent form

Exclusion

Exclusion Criteria:

  • Previous surgical history of malignant colorectal tumors
  • The surgical methods were combined abdominoperineal resection, Hartman operation andISR operation
  • There are contraindication of laparoscopic surgery, such as severe cardiopulmonaryinsufficiency
  • Patients who have undergone multiple abdominal and pelvic surgeries or extensiveabdominal adhesion
  • Patients with intestinal obstruction, intestinal perforation, intestinal bleeding andother emergency operations
  • ASA grade ≥IV and/or ECOG physical status score ≥2 points
  • Patients with severe liver and kidney function, cardiopulmonary function, coagulationdysfunction or combined with serious underlying diseases can not tolerate surgery
  • Have a history of serious mental illness
  • Patients with uncontrolled infection before operation

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Fluorescence laparoscopic system
Phase:
Study Start date:
May 01, 2023
Estimated Completion Date:
May 01, 2024

Study Description

Multiple studies, including randomized controlled trials (RCTs), have demonstrated that lymph node imaging techniques can effectively increase the number of harvested lymph nodes in gastric and colorectal cancer surgeries . However, there remains a scarcity of research specifically focused on the surgical procedure of fluorescent-guided clearance of No. 253 lymph nodes. Most existing studies have been retrospective analyses, and the need for prospective studies is evident. Further clinical research is crucial to explore the successful application of fluorescence lymph node imaging combined with indocyanine green (ICG) fluorescence angiography and its multifunctional fusion. To address this gap, investigators plan to conduct a randomized controlled trial comparing the outcomes between the use of ICG Fluorescence lymph node Imaging combined with Fluorescence angiography (FIFA group) and conventional techniques (non-ICG group) in laparoscopic rectal cancer surgery. Specifically, investigators focus will be on the preservation of the left colic artery (LCA) and the clearance of No. 253 lymph nodes. The primary objectives of our study are to simplify surgical procedures, enhance surgical safety, and provide substantial evidence for the further promotion and adoption of this technique.

Connect with a study center

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing 100021
    China

    Active - Recruiting

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