Clinical Study of Radical Right Hemicolectomy Versus Radical Right Hemicolectomy Combined with Indocyanine Green Fluorescence Imaging Lymphatic Tracer Dissection for the Treatment of Right Colon Cancer

Sun Yat-sen University

Status: Enrolling

Conditions: Colon Cancer

Treatments: Procedure: radical right hemicolectomy combined with indocyanine green fluorescence imaging lymphatic tracer dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT06485609

GIHSYSU-36

Details and patient eligibility

About

The purpose of this study is to explore the clinical outcomes of indocyanine green fluorescence using in laparoscopic radical right hemicolectomy for right colon cancer（T1-T4a N+ M0）

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Age between 18 and 75 years old 2. Confirmed adenocarcinoma cancer pathologically 3. Location of tumor: from the cecum to the right third of the transverse colon 4. CT showed right colon cancer: T1-T4a N+ M0 5. ASA scores I-III 6. ECOG (Eastern Cooperative Oncology Group) scale performance status of 0 or 1 7. Patient or family member, able to understand the study protocol and willing to participate in the study, providing written informed consent

Exclusion criteria

• 1. Simultaneous or heterochronic multiple primary colon cancer 2. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. requiring emergency surgery 3. Unsuitable for laparoscopic surgery (e.g., extensive adhesions due to previous major abdominal surgery; unsuitable for pneumoperitoneum for various reasons, etc.) 4. Pregnant or lactating women 5. Have a history of serious mental illness 6. History of iodine allergy 7. History of other malignant diseases within the last five years 8. History of prior neoadjuvant chemotherapy or radiation therapy 9. History of unstable angina or myocardial infarction within the last 6 months 10. History of continuous systemic corticosteroid use within one month

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,200 participants in 2 patient groups

radical right hemicolectomy

No Intervention group

radical right hemicolectomy combined with indocyanine green fluorescence imaging lymphatic tracer di

Experimental group

Treatment:

Procedure: radical right hemicolectomy combined with indocyanine green fluorescence imaging lymphatic tracer dissection