Clinical trial NCT06396806: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Sigmoid Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 1072
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Disease-free survival rate
timeFrame: 3 years after the surgery
Secondary outcomes:
measure: Total number of retrieved lymph nodes
timeFrame: 14 days after the surgery
measure: Number of Metastasis Lymph Nodes
timeFrame: 14 days after the surgery
measure: The number of lymph nodes at each station
timeFrame: 14 days after the surgery
measure: The rate of fluorescence
timeFrame: 14 days after the surgery
measure: Positive rate
timeFrame: 14 days after the surgery
measure: False positive rate
timeFrame: 14 days after the surgery
measure: Negative rate
timeFrame: 14 days after the surgery
measure: False negative rate
timeFrame: 14 days after the surgery
measure: Morbidity rate
timeFrame: 30 days after the surgery
measure: mortality rate
timeFrame: 30 days after the surgery
measure: Pathological outcomes checklist
timeFrame: 14 days after the surgery
measure: 3-year Overall survival rate
timeFrame: 3 years after the surgery
measure: 5-year Overall survival rate
timeFrame: 5 years after the surgery
measure: 5-year Disease-free survival rate
timeFrame: 5 years after the surgery
measure: Local recurrence rate
timeFrame: 3 years after the surgery
measure: Postoperative function (voiding function, sexual function) and quality of life
timeFrame: 3 years after the surgery
measure: The correlation between the number of lymph nodes and 3-year overall survival rate and 3-year disease-free survival rate
timeFrame: 3 years after the surgery
measure: Minimal Residual Disease, MRD
timeFrame: 3 years after the surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun yat-sen University, Sixth Affiliated Hospital
state: Guangdong
Study officials:
References: