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
About this trial
This is an interventional treatment trial for Rectal Cancer focused on measuring left colic artery, rectal cancer
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.
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
NCT ID
NCT03724591
First Posted
October 28, 2018
Last Updated
October 28, 2018
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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
Learn more about this trial
Total Mesorectum Excision With Left Colic Artery Preservation for the Treatment of Rectal Cancer
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