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 University1 site in 1 country1,072 target enrollmentMay 6, 2024

ConditionsSigmoid Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sigmoid Cancer
Sponsor: Sun Yat-sen University
Enrollment: 1072
Locations: 1
Primary Endpoint: Disease-free survival rate
Status: Enrolling By Invitation
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

May 6, 2024

End Date

December 31, 2030

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Yanhong Deng

Chief physician，Assistant to the dean

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•Age between 18 and 75 years old
•Confirmed sigmoid adenocarcinoma cancer pathologically
•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.
•CT showed sigmoid colon cancer: T3-4a N+ M0
•Patients with non-local recurrence or distant metastasis;
•no multiple colorectal cancer;
•no neoadjuvant therapy;
•physical conditions such as heart, lung, liver and kidney function can tolerate surgery.
•Willing and able to provide written informed consent for participation in this study

Exclusion Criteria

•Complicated with other malignant tumors or previous history of malignant tumors;
•patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc.;
•patients with tumor invasion or involvement of adjacent organs requiring combined organ resection;
•patients with poor anal function and incontinence before operation;
•patients with inflammatory bowel disease or familial adenomatous polyposis
•ASA grade ≥ IV and / or ECOG physical status score \> 2;
•patients with severe hepatorenal function, cardiopulmonary function, blood coagulation dysfunction or severe underlying diseases unable to tolerate surgery;
•history of severe mental illness;
•pregnant or lactating women;
•patients with uncontrolled infection before operation;

Outcomes

Primary Outcomes

Disease-free survival rate

Time Frame: 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 Outcomes

Negative rate(14 days after the surgery)
mortality rate(30 days after the 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)
The rate of fluorescence(14 days after the surgery)
Total number of retrieved lymph nodes(14 days after the surgery)
The number of lymph nodes at each station(14 days after the surgery)
Positive rate(14 days after the surgery)
False positive rate(14 days after the surgery)
False negative rate(14 days after the surgery)
Morbidity rate(30 days after the surgery)
5-year Overall survival rate(5 years after the surgery)
Pathological outcomes checklist(14 days after the surgery)
3-year Overall survival rate(3 years after the surgery)
5-year Disease-free survival rate(5 years after the surgery)
Local recurrence rate(3 years after the surgery)
Postoperative function (voiding function, sexual function) and quality of life(3 years after the surgery)