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Total Mesorectum Excision With Left Colic Artery Preservation for the Treatment of Rectal Cancer

Primary Purpose

Rectal Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
a high ligation of IMA
a low ligation of IMA
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring left colic artery, rectal cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients suitable for curative surgery over 18 years old;
  • American Society of Anesthesiologists(ASA) grade I-III;
  • Pathological diagnosis of rectal adenocarcinoma;
  • Patients suitable for abdominalperineal resection
  • Informed consent;
  • No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.

Exclusion Criteria:

  • Pregnant patient;
  • History of psychiatric disease;
  • Use of systemic steroids;
  • Simultaneous multiple primary colorectal cancer;
  • Preoperative imaging examination results show:1. Tumor involves the surrounding organs and combined organ resection need to be done;2. distant metastasis;3. unable to perform R0 resection;
  • History of any other malignant tumor in recent 5 years;
  • Patients need emergency operation: mechanic ileus, perforation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    a high ligation of IMA

    a low ligation of IMA

    Arm Description

    total mesorectal excision (TME) for rectal cancer by a high ligation of IMA without preservation of left colic artery

    total mesorectal excision (TME) for rectal cancer by a low ligation of IMA with preservation of left colic artery

    Outcomes

    Primary Outcome Measures

    Anastomosis leakage rate

    Secondary Outcome Measures

    Anastomosis bleeding rate
    disease-free survival
    local recurrence rate
    operative time
    number of lymph nodes retrieved
    postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire
    Compare the differences in postoperative quality of life of patients treated with these two regimens using EORTC QLQC30 questionnaire

    Full Information

    First Posted
    October 28, 2018
    Last Updated
    October 28, 2018
    Sponsor
    The First Affiliated Hospital with Nanjing Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03724591
    Brief Title
    Total Mesorectum Excision With Left Colic Artery Preservation for the Treatment of Rectal Cancer
    Official Title
    A Randomized Controlled Clinical Trial to Investigate the Effects of Total Mesorectum Excision With Left Colic Artery Preservation for the Treatment of Rectal Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2019 (Anticipated)
    Primary Completion Date
    January 2024 (Anticipated)
    Study Completion Date
    January 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The First Affiliated Hospital with Nanjing Medical University

    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
    A randomized controlled clinical trial to compare the short and long term outcomes of left colic artery preservation for the treatment of Rectal Cancer
    Detailed Description
    Rectal cancer is one of most frequently diagnosed cancers and one of the leading causes of cancer death around the world. Surgery remains the main treatment for rectal cancer. Anastomosis leakage (AL) is an unresolved, devastating and lethal complication after rectal cancer surgery and remains to be a serious difficulty for surgeons despite its causes, preventions and treatments having been extensively studied. To achieve a radical dissection of lymph nodes, it is necessary to remove the central lymph nodes at the root of inferior mesenteric artery(IMA) trunk.From the perspectives of lymph nodes dissection and tension-free anastomosis, it is preferred to perform a high ligation of IMA. However, there is still a controversy whether IMA should be high ligated or not. The argument mainly focuses on whether this performance will compromise the blood perfusion of the proximal limb of the anastomosis leading to the occurrence of AL. Some studies suggested that a high ligation did not increase the rate of AL. There are still many surgeons prefer the transection of IMA distal to the left colic artery(LCA) with the intention to preserve a good blood supply of the left colon after the performance of lymph node dissection around IMA. Some studies suggests that the preservation of LCA in anterior resection for mid and low rectal cancer is associated with lower rates of AL. Further investigations are needed to resolve the controversy. In this study, eligible patients will be randomly allocated to receive total mesorectal excision (TME) for rectal cancer either by a high ligation of IMA without preservation of left colic artery or a low ligation of IMA with preservation of left colic artery. Postoperative complications, including anastomosis leakage, anastomosis bleeding, will be recorded. Patients will be followed up every 3 months for 2 year, every 6 months for 3 years postoperatively to study the long term effects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rectal Cancer
    Keywords
    left colic artery, rectal cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    600 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    a high ligation of IMA
    Arm Type
    Experimental
    Arm Description
    total mesorectal excision (TME) for rectal cancer by a high ligation of IMA without preservation of left colic artery
    Arm Title
    a low ligation of IMA
    Arm Type
    Active Comparator
    Arm Description
    total mesorectal excision (TME) for rectal cancer by a low ligation of IMA with preservation of left colic artery
    Intervention Type
    Procedure
    Intervention Name(s)
    a high ligation of IMA
    Intervention Description
    total mesorectal excision (TME) for rectal cancer by a high ligation of IMA without preservation of left colic artery
    Intervention Type
    Procedure
    Intervention Name(s)
    a low ligation of IMA
    Intervention Description
    total mesorectal excision (TME) for rectal cancer by a low ligation of IMA with preservation of left colic artery
    Primary Outcome Measure Information:
    Title
    Anastomosis leakage rate
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Anastomosis bleeding rate
    Time Frame
    30 days
    Title
    disease-free survival
    Time Frame
    5 years
    Title
    local recurrence rate
    Time Frame
    5 years
    Title
    operative time
    Time Frame
    1 day
    Title
    number of lymph nodes retrieved
    Time Frame
    1 day
    Title
    postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire
    Description
    Compare the differences in postoperative quality of life of patients treated with these two regimens using EORTC QLQC30 questionnaire
    Time Frame
    5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients suitable for curative surgery over 18 years old; American Society of Anesthesiologists(ASA) grade I-III; Pathological diagnosis of rectal adenocarcinoma; Patients suitable for abdominalperineal resection Informed consent; No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease. Exclusion Criteria: Pregnant patient; History of psychiatric disease; Use of systemic steroids; Simultaneous multiple primary colorectal cancer; Preoperative imaging examination results show:1. Tumor involves the surrounding organs and combined organ resection need to be done;2. distant metastasis;3. unable to perform R0 resection; History of any other malignant tumor in recent 5 years; Patients need emergency operation: mechanic ileus, perforation.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yueming Sun, PhD
    Phone
    02568306026
    Email
    jssym@vip.sina.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fumin Zhang, Professor
    Phone
    02568306026
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yueming Sun, PhD
    Organizational Affiliation
    The First Affiliated Hospital with Nanjing Medical University
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Total Mesorectum Excision With Left Colic Artery Preservation for the Treatment of Rectal Cancer

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