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

Primary Purpose

Rectal Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vein ligation first
Artery ligation first
Sponsored by
Sichuan Cancer Hospital and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Vein ligation first

    Artery ligation first

    Arm Description

    During this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric vein ligated first.

    During this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric artery ligated first.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    3-year disease-free survival
    The proportion of patients with no disease recurrence and metastasis after 3 years of surgery
    3-years overall survival
    The proportion of patients who survived 3 years after surgery
    Recurrence pattern
    Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type
    Blood loss
    Blood loss during the surgery
    Operation time
    Operation time
    Conversive rate
    Conversive rate
    Number of lymph nodes collected
    Number of lymph nodes collected
    Intraoperative morbidity and mortality rates
    The intraoperative morbidity rates are defined as the rates of event observed within operation
    Postoperative morbidity and motality rates
    This is for the early postoperative complication, which defined as the event observed within 30 days after surgery
    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

    Full Information

    First Posted
    March 29, 2023
    Last Updated
    July 7, 2023
    Sponsor
    Sichuan Cancer Hospital and Research Institute
    Collaborators
    Sichuan Provincial People's Hospital, The Second People's Hospital of Chengdu
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05807646
    Brief Title
    Reduced Dissemination of Tumor Cells With Primary Ligation of the Inferior Mesenteric Vein in Rectal Cancer Patients.
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sichuan Cancer Hospital and Research Institute
    Collaborators
    Sichuan Provincial People's Hospital, The Second People's Hospital of Chengdu

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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 (ARVECTS)
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rectal Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    268 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Vein ligation first
    Arm Type
    Experimental
    Arm Description
    During this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric vein ligated first.
    Arm Title
    Artery ligation first
    Arm Type
    Active Comparator
    Arm Description
    During this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric artery ligated first.
    Intervention Type
    Other
    Intervention Name(s)
    Vein ligation first
    Intervention Description
    During this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric vein ligated first.
    Intervention Type
    Other
    Intervention Name(s)
    Artery ligation first
    Intervention Description
    During this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric artery ligated first.
    Primary Outcome Measure Information:
    Title
    The changes of the level of circulating tumor cells in the peripheral blood
    Description
    The changes of the level of circulating tumor cells in the peripheral blood before cutting the skin and after closing the abdomen
    Time Frame
    During the surgery
    Secondary Outcome Measure Information:
    Title
    3-year disease-free survival
    Description
    The proportion of patients with no disease recurrence and metastasis after 3 years of surgery
    Time Frame
    From date of surgery, assessed up to 36 months
    Title
    3-years overall survival
    Description
    The proportion of patients who survived 3 years after surgery
    Time Frame
    From date of surgery, assessed up to 36 months
    Title
    Recurrence pattern
    Description
    Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type
    Time Frame
    From date of surgery, assessed up to 36 months
    Title
    Blood loss
    Description
    Blood loss during the surgery
    Time Frame
    During the surgery
    Title
    Operation time
    Description
    Operation time
    Time Frame
    During the surgery
    Title
    Conversive rate
    Description
    Conversive rate
    Time Frame
    During the surgery
    Title
    Number of lymph nodes collected
    Description
    Number of lymph nodes collected
    Time Frame
    During the surgery
    Title
    Intraoperative morbidity and mortality rates
    Description
    The intraoperative morbidity rates are defined as the rates of event observed within operation
    Time Frame
    During the surgery
    Title
    Postoperative morbidity and motality rates
    Description
    This is for the early postoperative complication, which defined as the event observed within 30 days after surgery
    Time Frame
    30 days
    Title
    Postoperative recovery course
    Description
    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
    Time Frame
    10 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tao Pan, Doctor
    Phone
    +86-18181986821
    Email
    taopancd@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chao Liu, Professor
    Organizational Affiliation
    Sichuan Cancer Hospital and Research Institute
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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