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

Sun Yat-sen University

Status: Invitation-only

Conditions: Sigmoid Cancer

Treatments: Procedure: indocyanine green fluorescence imaging lymphatic tracing

Study type: Interventional

Funder types: Other

Identifiers

NCT06396806

GIHSYSU-35

Details and patient eligibility

About

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).

Enrollment: 1,072 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,072 participants in 2 patient groups

radical sigmoidectomy

No Intervention group

Description:

radical sigmoidectomy

radical sigmoidectomy combined with indocyanine green fluorescence imaging

Experimental group

Description:

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.

Treatment:

Procedure: indocyanine green fluorescence imaging lymphatic tracing