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

N/AEnrolling By InvitationNCT06396806

Sun Yat-sen University1,072 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,072

Conditions

Sigmoid Cancer

Interventions

indocyanine green fluorescence imaging lymphatic tracingPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Disease-free survival rate

odisease-free survival was defined as the time from surgery to the time of recurrence or death from any cause

Time frame: 3 years after the surgery

Secondary Outcomes

Total number of retrieved lymph nodes

Compare total number of retrieved lymph nodes in both group

Time frame: 14 days after the surgery

Number of Metastasis Lymph Nodes

Compare number of positive lymph nodes in both group.

Time frame: 14 days after the surgery

The number of lymph nodes at each station

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 14 days after the surgery

Morbidity rate

This is for the early postoperative complication

Time frame: 30 days after the surgery

mortality rate

mortality, which defined as the event observed within 30 days after surgery

Time frame: 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

Time frame: 14 days after the surgery

3-year Overall survival rate

Overall survival was defined as the time from surgery to death from any cause

Time frame: 3 years after the surgery

5-year Overall survival rate

Overall survival was defined as the time from surgery to death from any cause

Time frame: 5 years after the surgery

5-year Disease-free survival rate

Time frame: 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.

Time frame: 3 years after the surgery

Postoperative function (voiding function, sexual function) and quality of life

Time frame: 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

Time frame: 3 years after the surgery

Minimal Residual Disease, MRD

Time frame: 3 years after the surgery

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes