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Enrolling by invitation 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

No phase Interventional Sigmoid Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: indocyanine green fluorescence imaging lymphatic tracing.
Who it may be relevant to
Registry conditions: Sigmoid Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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).

Interventions

  • 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.

Primary outcome measures

  • Disease-free survival rate [Time frame: 3 years after the surgery]
Secondary outcome measures (12)
  • Total number of retrieved lymph nodes [Time frame: 14 days after the surgery]
  • Number of Metastasis Lymph Nodes [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 [Time frame: 14 days after the surgery]
  • Positive rate [Time frame: 14 days after the surgery]
  • False positive rate [Time frame: 14 days after the surgery]
  • Negative rate [Time frame: 14 days after the surgery]
  • False negative rate [Time frame: 14 days after the surgery]
  • Morbidity rate [Time frame: 30 days after the surgery]
  • mortality rate [Time frame: 30 days after the surgery]
  • Pathological outcomes checklist [Time frame: 14 days after the surgery]
  • 3-year Overall survival rate [Time frame: 3 years after the surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sun yat-sen University, Sixth Affiliated Hospital — Guangzhou

Identifiers

NCT: NCT06396806 · GIHSYSU-35

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗