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NCT Number: NCT06508541

The Prognosis of Colorectal Cancer Patients After Indocyanine Green Fluorescence-guided Radical Surgery

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 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 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

Observational

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, -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; and
  • severe mental disorder.

Treatment and study plan

ICG Guided surgery

Procedure

In ICG guided surgery group,Approximately 0.3 ml of ICG dissolved in 2.5 mg/ml of sterile water was injected submucosally by the endoscopic doctors through colonoscopy at two points around the tumor.All patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose using ICG lymphangiography procedure

conventional surgery

Procedure

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

Primary outcomes

  1. disease-free survival(DFS)

    Time frame: 1 month

    the duration from radical surgery to the confirmation of recurrence or metastasis by regular or telephone follow-up

Secondary outcomes

  1. the number of harvested lymph nodes

    Time frame: 1month

    the number of harvested lymph nodes including positive and negative ones

Sponsors and collaborators

Lead sponsor

Shanghai Tong Ren Hospital

Other

Registry information

Official study title

The Prognosis of Colorectal Cancer Patients After Indocyanine Green Fluorescence-guided Radical Surgery: a Retrospective Cohort Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2024
Registry last updated
Dec 16, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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