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

NCT ID: NCT06396806

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 1072 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-06
• Study Completion Date: 2030-12-31

Brief 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).

Conditions

Sigmoid Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

radical sigmoidectomy

radical sigmoidectomy

Group Type: NO_INTERVENTION

No interventions assigned to this group

radical sigmoidectomy combined with indocyanine green fluorescence imaging

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.

Group Type: EXPERIMENTAL

indocyanine green fluorescence imaging lymphatic tracing

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Yanhong Deng

Chief physician，Assistant to the dean

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sun yat-sen University, Sixth Affiliated Hospital

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

GIHSYSU-35

Identifier Type: -

Identifier Source: org_study_id