Comparing two surgical methods for treating right colon cancer
A Prospective, Randomized, Open, Parallel-controlled, Superiority 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
This study tests whether using special imaging during surgery helps people with right colon cancer recover better than just having the standard surgery alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Guangzhou) |
| Trial ID | NCT06485609 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the outcomes of radical right hemicolectomy alone versus a combined approach using indocyanine green fluorescence imaging for lymphatic tracer dissection in patients with right colon cancer. The study aims to determine if the addition of fluorescence imaging improves surgical results and patient recovery. Participants will undergo laparoscopic surgery, and their clinical outcomes will be monitored and compared. The trial focuses on patients with confirmed adenocarcinoma located in the right colon.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with confirmed adenocarcinoma of the right colon at specific stages (T1-T4a N+ M0).
Not a fit: Patients with multiple primary colon cancers, those requiring emergency surgery, or who are unsuitable for laparoscopic procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and recovery for patients with right colon cancer.
How similar studies have performed: While the use of indocyanine green fluorescence imaging is gaining traction, this specific combination approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Guangzhou
- The Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou, China (Recruiting)
Study contacts
- Study coordinator: Yanhong Deng, doctor
- Email: kangl@mail.sysu.edu.cn
- Phone: 38455369
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.