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Trial 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
NCT ID:
NCT06396806
Condition:
Sigmoid Cancer
Conditions: Official terms:
Sigmoid Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
indocyanine green fluorescence imaging lymphatic tracing
Description:
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.
Arm group label:
radical sigmoidectomy combined with indocyanine green fluorescence imaging
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).
Criteria for 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: 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
May 6, 2024
Completion date:
December 31, 2030
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06396806
