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NCT Number: NCT06583564

The Prognosis Effect of Indocyanine Green (ICG) Fluorescence Guided Surgery on Disease-free Survival (DFS) of Stage III Colorectal Cancer

Previous studies of Indocyanine green (ICG) in colorectal surgery have focused on lymphatic mapping, lymph node detection, and the number of harvested lymph nodes. However, relatively few studies have evaluated the outcomes of this imaging technology, especially the prognosis following of colorectal cancer resection. The present study assessed the prognosis of stage III colorectal cancer patients following ICG fluorescence-guided surgery as compared to conventional surgery without the use of ICG Fluorescence imaging

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Key information

Conditions

Colorectal Cancer Stage III Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Tongren Hospital

Changning, Shanghai Municipality, 200336, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age > 18 years,
  • confirmed diagnosis of primary CRC,
  • preoperative tumor stage of cT1 to cT4, N+, M0 as determined by contrast-enhanced computed tomography (CT),
  • no distant metastasis, and
  • American Society of Anesthesiologists(ASA)Physical Status Classification score of 1, 2, or 3

Exclusion criteria

  • history of previous colorectal surgery, emergent surgery, or palliative resection;
  • pregnancy or breastfeeding;
  • allergy or history of an adverse reaction to ICG
  • severe mental disorder.

Treatment and study plan

ICG lymphangiography procedure

Procedure

All patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose using ICG lymphangiography procedure

Primary outcomes

  1. Disease-free survival (DFS) rate

    Time frame: From radical surgery to the end of follow-up ,up to 36 months

    the rate of of no recurrence or metastasis after 3 years from radical surgery

Secondary outcomes

  1. the number of harvested lymph nodes

    Time frame: From radical surgery to the end of perioperative period at 1 month

    the number of harvested lymph nodes of radical surgery

  2. Postoperative complications

    Time frame: From radical surgery to the end of perioperative period at 1 month

    Postoperative complications ICG-related complications, surgery-related complications, and systemic complications. Postoperative complications were graded according to the Clavien-Dindo system

  3. Overall survival rate

    Time frame: From radical surgery to the end of follow-up ,up to 36 months

    the rate of 3 years overall survival after radical surgery

Sponsors and collaborators

Lead sponsor

Shanghai Tong Ren Hospital

Other

Registry information

Official study title

A Single Center Randomized Controlled Study of the Prognosis After Indocyanine Green Fluorescence-guided Radical Surgery in Colorectal Cancer Patients of Stage III

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Sep 4, 2024
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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