Reduced Dissemination of Tumor Cells With Primary Ligation of the Inferior Mesenteric Vein in Rectal Cancer Patients.

Официальное название

Effect of Ligation Sequence of the Inferior Mesenteric Artery and Vein on Circulating Tumor Cells and Survival in Laparoscopic Rectal Cancer Surgery: a Prospective, Multicenter, Randomized Controlled Study (ARVECTS)

Обзор

Effect of ligation sequence of the inferior mesenteric artery and vein on circulating tumor cells and survival in laparoscopic rectal cancer surgery: a prospective, multicenter, randomized controlled study (ARVECTS)

Подробное описание

Several studies have demonstrated that the presence of circulating tumor cells (CTCs) in the peripheral blood can be a surrogate biomarker to predict recurrence and prognosis of rectal cancer. CTCs are released from the primary tumor into the bloodstream and have the potential to spread to distant sites and develop into micro-metastatic deposits. Numerous studies have demonstrated that surgical manipulation could promote the dissemination of tumor cells into the circulation. Theoretically, the potential risk of tumor cell dissemination can theoretically be minimized if the effluent vein was ligated first. However, there is no regulation in the current guidelines on the sequence of ligation of the inferior mesenteric artery and vein during rectal cancer surgery owing to a lack of sufficient evidence. This multi-center randomized controlled trial is to investigate effect of ligation sequence of the inferior mesenteric artery and vein on circulating tumor cells and survival in laparoscopic rectal cancer surgery

Вмешательства

• Другое Vein ligation first
  During this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric vein ligated first.
• Другое Artery ligation first
  During this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric artery ligated first.

Первичные конечные точки

• The changes of the level of circulating tumor cells in the peripheral blood [Срок оценки: During the surgery]

Вторичные конечные точки (10)

• 3-year disease-free survival [Срок оценки: From date of surgery, assessed up to 36 months]
• 3-years overall survival [Срок оценки: From date of surgery, assessed up to 36 months]
• Recurrence pattern [Срок оценки: From date of surgery, assessed up to 36 months]
• Blood loss [Срок оценки: During the surgery]
• Operation time [Срок оценки: During the surgery]
• Conversive rate [Срок оценки: During the surgery]
• Number of lymph nodes collected [Срок оценки: During the surgery]
• Intraoperative morbidity and mortality rates [Срок оценки: During the surgery]
• Postoperative morbidity and motality rates [Срок оценки: 30 days]
• Postoperative recovery course [Срок оценки: 10 days]

Критерии участия

Критерии включения

• Age: 18-75 years;
• Histopathologically confirmed as rectal adenocarcinoma(tumor located within 15 cm from the anal verge at colonoscopy);
• Patients with a stage I-III rectal cancer eligible for surgery and R0 resection is expected, patients with pelvic lateral lymph nodes metastasis are ineligible;
• ECOG score: 0-1;
• ASA score: I/II/III;
• Laparoscopic surgery;
• Informed consent.

Критерии исключения

• Patients who have received preoperative treatment (such as preoperative radiotherapy and chemotherapy);
• Receiving transanal total mesorectal excision (taTME), specimen extraction through natural lumen (NOSES) ;
• Recurrent rectal cancer;
• Simultaneous or metachronous colorectal cancer;
• Malignant tumors of other organs in the past 5 years or at the same time;
• The results of preoperative physical examination and imaging examination showed that: (1) the tumor involved the surrounding organs and required combined organ resection; (2) distant metastasis; (3) could not be resected at R0;
• Pregnant or lactating women;
• Patients with severe mental disorder;
• It is not suitable for patients undergoing laparoscopic surgery (such as extensive adhesion caused by previous abdominal surgery or inability to tolerate artificial pneumoperitoneum);
• History of unstable angina pectoris or myocardial infarction in the past 6 months;
• Have a history of cerebrovascular accident in the past 6 months;
• Systemic administration of corticosteroids within 1 month before enrollment;
• Taking folic acid related drugs within half a year before operation.
• Severe cardiac insufficiency (FEV1<50% of predicted values);
• Emergency surgery.

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

Список центров уточняется — проверьте первичный протокол.

Публикации

• Pan T, Hu H, Liu C, Zhou HY. Effect of ligation sequence of the inferior mesenteric artery and vein on circulating tumour cells and survival in minimally invasive rectal cancer surgery: study protocol for a randomised controlled trial (ARVECTS study). BMJ Open. 2025 Nov 19;15(11):e098428. doi: 10.1136/bmjopen-2024-098428. PMID 41263842

Идентификаторы

NCT: NCT05807646 · SichuanCHRI123

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗