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

Rectal Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05807646
• Other study ID #: SichuanCHRI123
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2025
• Est. completion date: December 2028

Study information

• Verified date: February 2024
• Source: Sichuan Cancer Hospital and Research Institute
• Contact: Tao Pan, Doctor
• Phone: +86-18181986821
• Email: taopancd[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (ARVECTS)

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 268
• Est. completion date: December 2028
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age: 18-75 years;

2. Histopathologically confirmed as rectal adenocarcinoma(tumor located within 15 cm from the anal verge at colonoscopy);

3. 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;

4. ECOG score: 0-1;

5. ASA score: I/II/III;

6. Laparoscopic surgery;

7. Informed consent.

Exclusion Criteria:

1. Patients who have received preoperative treatment (such as preoperative radiotherapy and chemotherapy);

2. Receiving transanal total mesorectal excision (taTME), specimen extraction through natural lumen (NOSES) ;

3. Recurrent rectal cancer;

4. Simultaneous or metachronous colorectal cancer;

5. Malignant tumors of other organs in the past 5 years or at the same time;

6. 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;

7. Pregnant or lactating women;

8. Patients with severe mental disorder;

9. It is not suitable for patients undergoing laparoscopic surgery (such as extensive adhesion caused by previous abdominal surgery or inability to tolerate artificial pneumoperitoneum);

10. History of unstable angina pectoris or myocardial infarction in the past 6 months;

11. Have a history of cerebrovascular accident in the past 6 months;

12. Systemic administration of corticosteroids within 1 month before enrollment;

13. Taking folic acid related drugs within half a year before operation.

14. Severe cardiac insufficiency (FEV1<50% of predicted values);

15. Emergency surgery.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Sichuan Cancer Hospital and Research Institute	Sichuan Provincial People's Hospital, The Second People's Hospital of Chengdu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The changes of the level of circulating tumor cells in the peripheral blood	The changes of the level of circulating tumor cells in the peripheral blood before cutting the skin and after closing the abdomen	During the surgery
Secondary	3-year disease-free survival	The proportion of patients with no disease recurrence and metastasis after 3 years of surgery	From date of surgery, assessed up to 36 months
Secondary	3-years overall survival	The proportion of patients who survived 3 years after surgery	From date of surgery, assessed up to 36 months
Secondary	Recurrence pattern	Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type	From date of surgery, assessed up to 36 months
Secondary	Blood loss	Blood loss during the surgery	During the surgery
Secondary	Operation time	Operation time	During the surgery
Secondary	Conversive rate	Conversive rate	During the surgery
Secondary	Number of lymph nodes collected	Number of lymph nodes collected	During the surgery
Secondary	Intraoperative morbidity and mortality rates	The intraoperative morbidity rates are defined as the rates of event observed within operation	During the surgery
Secondary	Postoperative morbidity and motality rates	This is for the early postoperative complication, which defined as the event observed within 30 days after surgery	30 days
Secondary	Postoperative recovery course	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	10 days