Reduced Dissemination of Tumor Cells With Primary Ligation of the Inferior Mesenteric Vein in Rectal Cancer Patients.
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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:
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Vein ligation first During this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric vein ligated first. |
Other: Vein ligation first
During this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric vein ligated first.
|
| Active Comparator: Artery ligation first During this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric artery ligated first. |
Other: Artery ligation first
During this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric artery ligated first.
|
Outcome Measures
Primary Outcome Measures
- The changes of the level of circulating tumor cells in the peripheral blood [During the surgery]
The changes of the level of circulating tumor cells in the peripheral blood before cutting the skin and after closing the abdomen
Secondary Outcome Measures
- 3-year disease-free survival [From date of surgery, assessed up to 36 months]
The proportion of patients with no disease recurrence and metastasis after 3 years of surgery
- 3-years overall survival [From date of surgery, assessed up to 36 months]
The proportion of patients who survived 3 years after surgery
- 3-year recurrence pattern [From date of surgery, assessed up to 36 months]
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type
- Blood loss [During the surgery]
Blood loss during the surgery
- Operation time [During the surgery]
Operation time
- Conversive rate [During the surgery]
Conversive rate
- Number of lymph nodes collected [During the surgery]
Number of lymph nodes collected
- Intraoperative morbidity and mortality rates [During the surgery]
The intraoperative morbidity rates are defined as the rates of event observed within operation
- Postoperative morbidity and motality rates [30 days]
This is for the early postoperative complication, which defined as the event observed within 30 days after surgery
- Postoperative recovery course [10 days]
Time to first ambulation, flatus, liquid diet and soft diet, duration of postoperative hospital stay and postoperative pain are used to assess the postoperative recovery course.Visual analog pain score method is used to evaluate the difference of postoperative pain degree
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age: 18-75 years;
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Histopathologically confirmed as rectal adenocarcinoma(tumor located within 15 cm from the anal verge at colonoscopy);
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Patients with a stage I-III rectal cancer eligible for surgery and R0 resection is expected, patients with pelvic lateral lymph nodes are ineligible;
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ECOG score: 0-1;
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ASA score: I/II/III;
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Laparoscopic surgery;
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Informed consent.
Exclusion Criteria:
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Patients who have received preoperative treatment (such as preoperative radiotherapy and chemotherapy);
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Receiving transanal total mesorectal excision (taTME), specimen extraction through natural lumen (NOSES) or endoscopic tumor resection;
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Recurrent rectal cancer;
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Simultaneous or metachronous colorectal cancer;
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Malignant tumors of other organs in the past 5 years or at the same time;
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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;
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Pregnant or lactating women;
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Patients with severe mental disorder;
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It is not suitable for patients undergoing laparoscopic surgery (such as extensive adhesion caused by previous abdominal surgery or inability to tolerate artificial pneumoperitoneum);
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History of unstable angina pectoris or myocardial infarction in the past 6 months;
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Have a history of cerebrovascular accident in the past 6 months;
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Systemic administration of corticosteroids within 1 month before enrollment;
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Taking folic acid related drugs within half a year before operation.
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Severe cardiac insufficiency (FEV1<50% of predicted values);
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Emergency surgery.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sichuan Cancer Hospital and Research Institute
- Sichuan Provincial People's Hospital
- The Second People's Hospital of Chengdu
Investigators
- Study Director: Chao Liu, Professor, Sichuan Cancer Hospital and Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SichuanCHRI123