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

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Sigmoid Cancer
• Intervention / Treatment: Procedure: indocyanine green fluorescence imaging lymphatic tracing

• Study Type: Interventional
• Enrollment (Estimated): 1072
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510655
      • Sun yat-sen University, Sixth Affiliated Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: radical sigmoidectomy
Experimental: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of retrieved lymph nodes	Compare total number of retrieved lymph nodes in both group	14 days after the surgery
Number of Metastasis Lymph Nodes	Compare number of positive lymph nodes in both group.	14 days after the surgery
The number of lymph nodes at each station		14 days after the surgery
The rate of fluorescence	The number of fluorescent lymph node in experimental group is divided by the total number of lymph nodes in active experimental group	14 days after the surgery
Positive rate	The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group	14 days after the surgery
False positive rate	The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group	14 days after the surgery
Negative rate	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	14 days after the surgery
False negative rate	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	14 days after the surgery
Morbidity rate	This is for the early postoperative complication	30 days after the surgery
mortality rate	mortality, which defined as the event observed within 30 days after surgery	30 days after the surgery
Pathological outcomes checklist	Quality of the mesorectum specimen, number of harvested lymph nodes, status of circumferential resection margin, and distal resection margin	14 days after the surgery
3-year Overall survival rate	Overall survival was defined as the time from surgery to death from any cause	3 years after the surgery
5-year Overall survival rate	Overall survival was defined as the time from surgery to death from any cause	5 years after the surgery
5-year Disease-free survival rate		5 years after the surgery
Local recurrence rate	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.	3 years after the surgery
Postoperative function (voiding function, sexual function) and quality of life		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
Minimal Residual Disease, MRD		3 years after the surgery

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: May 1, 2024
• First Posted (Actual): May 2, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Sigmoid Diseases; Colonic Neoplasms; Sigmoid Neoplasms
• Other Study ID Numbers: GIHSYSU-35

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No