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

NCT ID: NCT03724591

Last Updated: 2018-10-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-31
• Study Completion Date: 2024-01-31

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.

Conditions

Rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

a high ligation of IMA

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

Group Type: EXPERIMENTAL

a high ligation of IMA

Intervention Type: PROCEDURE

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

a low ligation of IMA

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

Group Type: ACTIVE_COMPARATOR

a low ligation of IMA

Intervention Type: PROCEDURE

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

Interventions

a high ligation of IMA

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

Intervention Type: 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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yueming Sun, PhD

Role: STUDY_DIRECTOR

The First Affiliated Hospital with Nanjing Medical University

Central Contacts

Yueming Sun, PhD

Role: CONTACT

jssym@vip.sina.com

02568306026

Fumin Zhang, Professor

Role: CONTACT

02568306026

Other Identifiers

CRSYM201810

Identifier Type: -

Identifier Source: org_study_id