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

Обзор

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).

Вмешательства

• Процедура 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.

Первичные конечные точки

• Disease-free survival rate [Срок оценки: 3 years after the surgery]

Вторичные конечные точки (12)

• Total number of retrieved lymph nodes [Срок оценки: 14 days after the surgery]
• Number of Metastasis Lymph Nodes [Срок оценки: 14 days after the surgery]
• The number of lymph nodes at each station [Срок оценки: 14 days after the surgery]
• The rate of fluorescence [Срок оценки: 14 days after the surgery]
• Positive rate [Срок оценки: 14 days after the surgery]
• False positive rate [Срок оценки: 14 days after the surgery]
• Negative rate [Срок оценки: 14 days after the surgery]
• False negative rate [Срок оценки: 14 days after the surgery]
• Morbidity rate [Срок оценки: 30 days after the surgery]
• mortality rate [Срок оценки: 30 days after the surgery]
• Pathological outcomes checklist [Срок оценки: 14 days after the surgery]
• 3-year Overall survival rate [Срок оценки: 3 years after the surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sun yat-sen University, Sixth Affiliated Hospital — Гуанчжоу

Идентификаторы

NCT: NCT06396806 · GIHSYSU-35

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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