A Prospective Clinical Study for Laparoscopic D3 Dissection With Preservation of Left Colic Artery in Rectal Cancer

May 10, 2016 updated by: LI XIN-XIANG, Fudan University

A Prospective Randomized Clinical Study for Laparoscopic D3 Lymph Node Dissection With Preservation of Left Colic Artery in Rectal Cancer Surgery

During surgery for rectal cancer, there is considerable controversy regarding the optimal level of ligation of the inferior mesenteric artery. Several studies have demonstrated the benefit of high ligation of the inferior mesenteric artery for the rectal cancer in order to achieve block dissection of lymph node metastases along the root of the inferior mesenteric artery. In contrast, other studies have shown a significant decrease in blood flow after inferior mesenteric artery clamping that may increase the risk of anastomotic ischemia and the long-term outcomes were not significantly different between high ligation of the inferior mesenteric artery and low ligation. So, a modified procedure was suggested to dissect fatty tissues and nodes in the angle between the inferior mesenteric artery and the left colic artery and the artery was ligated below the left colic artery. In the present clinical trial, the investigators perform laparoscopic surgery with this management strategy in rectal cancer. Thus, the goal of this study is to investigate the short-term and oncologic long-term outcomes associated with laparoscopic lymph node dissection around the inferior mesenteric artery with preservation of the left colic artery for rectal cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

During surgery for rectal cancer, there is considerable controversy regarding the optimal level of ligation of the inferior mesenteric artery.There has been a differentiation between a high versus low ligation of the inferior mesenteric artery related to whether or not the ligation is above (high ligation) or below (low ligation) the left colic artery. Several studies have demonstrated the benefit of high ligation of the inferior mesenteric artery for the rectal cancer in order to achieve block dissection of lymph node metastases along the root of the inferior mesenteric artery. Excision of the apical lymph node at the root of the inferior mesenteric artery is thought to be necessary for radical resection of rectal cancer because apical lymph node resection contributes to improve lymph node retrieval rates and the accuracy of tumour staging. In contrast, other studies have shown a significant decrease in blood flow after inferior mesenteric artery clamping that may increase the risk of anastomotic ischemia. Patients with high ligation of inferior mesenteric artery had a 3.8 times higher chance of leaking than those with low ligation. Several studies confirmed that the long-term outcomes were not significantly different between high ligation of the inferior mesenteric artery and low ligation. So, a modified procedure was suggested to dissect fatty tissues and nodes in the angle between the inferior mesenteric artery and left colic artery and the artery was ligated below the left colic artery, which represented a compromise between the high and low ligation. Recently, several studies have described laparoscopic lymph node dissection around the inferior mesenteric artery with preservation of the left colic artery for rectosigmoid colon cancer. However, there are a few reports that describe the clinical outcomes associated with this management strategy. Furthermore, the long-term outcomes for laparoscopic lymphadenectomy around the inferior mesenteric artery with rectal cancer have seldom been reported. In the present clinical trial, the investigators perform laparoscopic surgery with this management strategy in rectal cancer. Thus, the goal of this study is to investigate the short-term and oncologic long-term outcomes associated with laparoscopic lymph node dissection around the inferior mesenteric artery with preservation of the left colic artery for rectal cancer.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xin-Xiang LI, Ph.D
  • Phone Number: +86-18017312900
  • Email: lxx1149@163.com

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Sub-Investigator:
          • LEI LIANG, DOCTOR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. pathological confirmed rectal adenocarcinoma
  2. solitary radical resectable tumors
  3. tumor located at 5-15cm from the anus

Exclusion Criteria:

  1. recurrent cases
  2. emergency including obstruction, bleeding or perforation
  3. severe abdominal adhesions
  4. severe malnutrition can not be improved before surgery
  5. can not tolerate to surgery due to severe comorbidities of heart, lung, liver or kidney
  6. refractory hypoproteinemia or diabetes mellitus
  7. previous or concomitant other cancers
  8. the patients performed APR or hartmann surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: left colic artery group
Laparoscopic D3 Lymph Node Dissection with preservation of the left colic artery
Procedure: left colic artery
Laparoscopic D3 Lymph Node Dissection with preservation of left colic artery
Active Comparator: High ligation group
Laparoscopic D3 Lymph Node Dissection with high ligation
Procedure: High ligation
Laparoscopic D3 Lymph Node Dissection with ligation above the left colic artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anastomotic leak rate
Time Frame: 30 days since the date of surgery
percentage of patients occuring anastomotic leak within 30 days since surgery
30 days since the date of surgery
Number of lymph node dissection
Time Frame: 10 days since the date of surgery
10 days since the date of surgery
Overall survival rate
Time Frame: 3 years since the date of surgery
3 years total survival rate after surgery
3 years since the date of surgery
disease-free survival rate
Time Frame: 3 years since the date of surgery
3 years disease-free survival rate after surgery
3 years since the date of surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
30-day mortality rate
Time Frame: within 30 days since the date of surgery
within 30 days since the date of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

April 3, 2016

First Submitted That Met QC Criteria

April 25, 2016

First Posted (Estimate)

April 27, 2016

Study Record Updates

Last Update Posted (Estimate)

May 11, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUDANLCA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rectal Neoplasms

Clinical Trials on left colic artery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe