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

Not Applicable

• Conditions: Sigmoid Cancer
• Interventions: Procedure: indocyanine green fluorescence imaging lymphatic tracing

• Registration Number: NCT06396806
• Lead Sponsor: Sun Yat-sen University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-30
• Study First Submitted QC: 2024-05-01
• Study First Posted: 2024-05-02
• Study Start: 2024-05-06
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-17
• Primary Completion: 2027-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1072

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
radical sigmoidectomy combined with indocyanine green fluorescence imaging	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.

Primary Outcome Measures

Name	Time	Method
Disease-free survival rate	3 years after the surgery	odisease-free survival was defined as the time from surgery to the time of recurrence or death from any cause

Secondary Outcome Measures

Name	Time	Method
Negative rate	14 days after the surgery	The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in experimental group
mortality rate	30 days after the surgery	mortality, which defined as the event observed within 30 days after surgery
Minimal Residual Disease, MRD	3 years after the surgery
The correlation between the number of lymph nodes and 3-year overall survival rate and 3-year disease-free survival rate	3 years after the surgery
Number of Metastasis Lymph Nodes	14 days after the surgery	Compare number of positive lymph nodes in both group.
The rate of fluorescence	14 days after the surgery	The number of fluorescent lymph node in experimental group is divided by the total number of lymph nodes in active experimental group
Total number of retrieved lymph nodes	14 days after the surgery	Compare total number of retrieved lymph nodes in both group
The number of lymph nodes at each station	14 days after the surgery
Positive rate	14 days after the surgery	The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group
False positive rate	14 days after the surgery	The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group
False negative rate	14 days after the surgery	The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in experimental group
Morbidity rate	30 days after the surgery	This is for the early postoperative complication
5-year Overall survival rate	5 years after the surgery	Overall survival was defined as the time from surgery to death from any cause
Pathological outcomes checklist	14 days after the surgery	Quality of the mesorectum specimen, number of harvested lymph nodes, status of circumferential resection margin, and distal resection margin
3-year Overall survival rate	3 years after the surgery	Overall survival was defined as the time from surgery to death from any cause
5-year Disease-free survival rate	5 years after the surgery
Local recurrence rate	3 years after the surgery	Local recurrence was defined as radiologic or histopathologic evidence of any recurrent disease deposit located in the pelvis in the prior area of dissection following a primary rectal cancer resection, with or without distal metastasis.
Postoperative function (voiding function, sexual function) and quality of life	3 years after the surgery

Trial Locations

Locations (1)

Sun yat-sen University, Sixth Affiliated Hospital; 🇨🇳 Guangzhou, Guangdong, China