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

A Randomized Controlled Clinical Trial to Investigate the Effects of Total Mesorectum Excision With Left Colic Artery Preservation for the Treatment of Rectal Cancer

A randomized controlled clinical trial to compare the short and long term outcomes of left colic artery preservation for the treatment of Rectal Cancer

Study Overview

• Status: Not yet recruiting
• Conditions: Rectal Cancer
• Intervention / Treatment: Procedure: a high ligation of IMA; Procedure: a low ligation of IMA

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.

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yueming Sun, PhD; Phone Number: 02568306026; Email: jssym@vip.sina.com
• Study Contact Backup: Name: Fumin Zhang, Professor; Phone Number: 02568306026

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: a high ligation of IMA; total mesorectal excision (TME) for rectal cancer by a high ligation of IMA without preservation of left colic artery	Procedure: a high ligation of IMA; total mesorectal excision (TME) for rectal cancer by a high ligation of IMA without preservation of left colic artery
Active Comparator: a low ligation of IMA; total mesorectal excision (TME) for rectal cancer by a low ligation of IMA with preservation of left colic artery	Procedure: a low ligation of IMA; total mesorectal excision (TME) for rectal cancer by a low ligation of IMA with preservation of left colic artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Anastomosis leakage rate	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative time		1 day
local recurrence rate		5 years
disease-free survival		5 years
Anastomosis bleeding rate		30 days
number of lymph nodes retrieved		1 day
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	5 years

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Investigators: Study Director: Yueming Sun, PhD, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: October 28, 2018
• First Submitted That Met QC Criteria: October 28, 2018
• First Posted (Actual): October 30, 2018

Study Record Updates

• Last Update Posted (Actual): October 30, 2018
• Last Update Submitted That Met QC Criteria: October 28, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: rectal cancer; left colic artery
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: CRSYM201810

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No