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Clinical Trials in China / NCT06396806
Enrolling by invitation Not applicable

A Prospective, Randomized, Open, Parallel-controlled, Superior-efficacy Clinical Study of Radical Sigmoidectomy for Sigmoid Cancer Versus Radical Sigmoidectomy Combined with Indocyanine Green Fluorescence Imaging Lymphatic Tracing Dissection in the Treatment of Sigmoid Cancer

NCT06396806 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Not applicable
Started
2024-05-06
Last updated
2025-01-17

Condition(s) studied

Sigmoid Cancer

Investigational drug(s) / intervention(s)

indocyanine green fluorescence imaging lymphatic tracing

indocyanine green fluorescence imaging lymphatic tracing: At the end of routine operation, indocyanine green was used for lymph node tracing, and further lymph node dissection was performed according to the tracer results.

Study summary

he purpose of this study is to explore the clinical outcomes of Indocyanine Green Tracer using in laparoscopic radical sigmoidectomy for sigmoid adenocarcinoma (cT2-T4a N0 M0,T1-T4a N+ M0).

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age between 18 and 75 years old 2. Confirmed sigmoid adenocarcinoma cancer pathologically 3. Location of tumor: the sigmoid colon (descending colon from vertical to horizontal point) is the starting point of sigmoid colon, and the end point of sigmoid colon is at 15cm of anal margin. 4. CT showed sigmoid colon cancer: T3-4a N+ M0 5. Patients with non-local recurrence or distant metastasis; 6. no multiple colorectal cancer; 7. no neoadjuvant therapy; 8. physical conditions such as heart, lung, liver and kidney function can tolerate surgery. 9. Willing and able to provide written informed consent for participation in this study Exclusion Criteria: 1. Complicated with other malignant tumors or previous history of malignant tumors; 2. patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc.; 3. patients with tumor invasion or involvement of adjacent organs requiring combined organ resection; 4. patients with poor anal function and incontinence before operation; 5. patients with inflammatory bowel disease or familial adenomatous polyposis 6. ASA grade ≥ IV and / or ECOG physical status score \> 2; 7. patients with severe hepatorenal function, cardiopulmonary function, blood coagulation dysfunction or severe underlying diseases unable to tolerate surgery; 8. history of severe mental illness; 9. pregnant or lactating women; 10. patients with uncontrolled infection before operation; 11. patients with other clinical and laboratory conditions considered by some researchers should not participate in this trial.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sun yat-sen University, Sixth Affiliated Hospital Guangzhou Guangdong

More Sun Yat-sen University trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06396806 on ClinicalTrials.gov ↗ ← All trials in China