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

Sigmoid Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06396806
• Other study ID #: GIHSYSU-35
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 6, 2024
• Est. completion date: December 31, 2030

Study information

• Verified date: April 2024
• Source: Sun Yat-sen University
• Contact: Liang Kang, MD. and Phd.
• Phone: 02038455369
• Email: kangl[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 564
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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: T2-T4a N0 M0 T1murT4a N0 + 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.

Related Conditions & MeSH terms

• Sigmoid Cancer
• Sigmoid Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total number of retrieved lymph nodes	Compare total number of retrieved lymph nodes in both group	14 days after the surgery
Secondary	Number of Metastasis Lymph Nodes	Compare number of positive lymph nodes in both group.	14 days after the surgery
Secondary	The number of lymph nodes at each station		14 days after the surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Morbidity rate	This is for the early postoperative complication	30 days after the surgery
Secondary	mortality rate	mortality, which defined as the event observed within 30 days after surgery	30 days after the surgery
Secondary	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
Secondary	3-year Overall survival rate	Overall survival was defined as the time from surgery to death from any cause	3 years after the surgery
Secondary	5-year Overall survival rate	Overall survival was defined as the time from surgery to death from any cause	5 years after the surgery
Secondary	5-year Disease-free survival rate		5 years after the surgery
Secondary	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
Secondary	Postoperative function (voiding function, sexual function) and quality of life		3 years after the surgery
Secondary	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
Secondary	Minimal Residual Disease, MRD		3 years after the surgery