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

NCT06485609 | Recruiting DMC

• 1 other identifier: GIHSYSU-36
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

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）

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free survival rate

  3 years

Secondary Outcomes (1)

• Number of lymph nodes cleared

  Immediately after surgery

Study Arms (2)

radical right hemicolectomy

NO INTERVENTION

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

EXPERIMENTAL

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

Interventions

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

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

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, China

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Yanhong Deng, doctor

CONTACT

38455369; kangl@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: July 3, 2024
• Study Start: August 10, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2031
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)