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Enrolling by Invitation

NCT Number: 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

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).

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sun yat-sen University, Sixth Affiliated Hospital

Guangzhou, Guangdong, 510655, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • patients with other clinical and laboratory conditions considered by some researchers should not participate in this trial.

Treatment and study plan

indocyanine green fluorescence imaging lymphatic tracing

Procedure

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.

Primary outcomes

  1. 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

  1. Total number of retrieved lymph nodes

    Time frame: 14 days after the surgery

    Compare total number of retrieved lymph nodes in both group

  2. Number of Metastasis Lymph Nodes

    Time frame: 14 days after the surgery

    Compare number of positive lymph nodes in both group.

  3. The number of lymph nodes at each station

    Time frame: 14 days after the surgery

  4. The rate of fluorescence

    Time frame: 14 days after the surgery

    The number of fluorescent lymph node in experimental group is divided by the total number of lymph nodes in active experimental group

  5. Positive rate

    Time frame: 14 days after the surgery

    The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group

  6. False positive rate

    Time frame: 14 days after the surgery

    The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group

  7. Negative rate

    Time frame: 14 days after the surgery

    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

  8. False negative rate

    Time frame: 14 days after the surgery

    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

  9. Morbidity rate

    Time frame: 30 days after the surgery

    This is for the early postoperative complication

  10. mortality rate

    Time frame: 30 days after the surgery

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

  11. Pathological outcomes checklist

    Time frame: 14 days after the surgery

    Quality of the mesorectum specimen, number of harvested lymph nodes, status of circumferential resection margin, and distal resection margin

  12. 3-year Overall survival rate

    Time frame: 3 years after the surgery

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

  13. 5-year Overall survival rate

    Time frame: 5 years after the surgery

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

  14. 5-year Disease-free survival rate

    Time frame: 5 years after the surgery

  15. Local recurrence rate

    Time frame: 3 years after the surgery

    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.

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

    Time frame: 3 years after the surgery

  17. 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

  18. Minimal Residual Disease, MRD

    Time frame: 3 years after the surgery

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2030
First posted
May 2, 2024
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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