Comparison of Low and High Ligation With Apical Lymph Node Dissection in the Laparoscopy Rectal Cancer (PLAND)

September 7, 2020 updated by: WEIDONG LIU，MD

Preservation of the Left Colic Artery With Apical Lymph Node Dissection in Laparoscopic Rectal Cancer Surgery

The purpose of this study is to explore the different impacts of high and low ligation in laparoscopic rectal interior resection on postoperative anastomotic leakage and proximal bowel necrosis and stenosis, as well as the quality of life and long-term survival. In the anterior resection of rectum, the section level of inferior mesenteric artery (IMA) is still a controversial subject between the advocates of high and low ligation. The low ligation is defined as the IMA is ligated below the origin of the left colic artery while the high ligation refers to the IMA is ligated at its origin from the aorta. Nowadays the spread of laparoscopy has encouraged more frequent execution of the high ligation, which appears easier to achieve than the low ligation and also with the advantage of lower anastomosis traction but with the disadvantage of worse vascularization of the stumps as well.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

It has long been debated that whether to tie off the inferior mesenteric artery (IMA) at its origin or just below the origin of the left colic artery (LCA) of the anterior resection of the rectum. Thus far, no clear consensus has been achieved, and the level of arterial ligation still varies among institutions and patients. In the previous studies, high or low ligation takes advantage on both sides. However, there are still some researches that have demonstrated no significant difference had been found in the incidence of anastomotic leakage and other complications between the high and low ligation groups. Therefore, to provide a clear and definite answer to surgeons of how they should deal with the IMA in laparoscopy rectal surgery. We plan to explore the impacts of high and low tie in laparoscopic anterior rectal resection on postoperative anastomotic leakage and proximal bowel necrosis and stenosis, as well as the quality of life and long-term survival by prospective and multi-center clinical trial.

Surgery will be described as follows:

For low ligation group:

  1. Laparoscopic surgery is performed. Tie the sigmoid artery and superior rectal artery, LCA is preserved. Lymphadenectomy to Apical lymph nodes is performed. Strip the beginning part of upper rectal artery and the first sigmoid artery. Strip the left colic artery until reaching the inferior mesenteric vein (IMV). The abdominal aorta lymph nodes need to be cleaned if it's been spotted swollen.
  2. Vascular ligation level: Left colonic artery needs to be preserved, the rectal artery and the first sigmoid artery are ligated. Ligate inferior mesenteric artery below left colonic artery come across the inferior mesenteric vein level.

For high ligation groups:

Laparoscopic surgery is performed. The IMA is ligated and divided at 2 cm. from its origin. Dissect the adipose tissue and lymph nodes around IMA. The inferior mesenteric vein (IMV) is divided and ligated below the duodenal margin. The abdominal aorta lymph nodes need to be cleaned if it's been spotted swollen. For both groups Total Mesolectal Excision (TME) is performed according to the principles of Heald.

Study Type

Interventional

Enrollment (Anticipated)

466

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

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410000
        • Recruiting
        • Xiangya Hospital of Central South University
        • Contact:

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

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 Years to 75 Years (Adult, Senior).
  • Colonoscopy and pathology shows rectal or sigmoid adenocarcinoma.
  • Tumor located at 4-15 cm from the dentate line.
  • The clinical staging of tumor by MRI within T1-4a when tumor Above the peritoneum and T3N0-2 when tumor below the peritoneum.
  • Receive or not receive neoadjuvant chemotherapy based on 5-fluorouracil before surgery and radical resection is available after neoadjuvant chemotherapy.
  • Anus-saving operation is available.
  • ASA class: I-III.
  • Well tolerate to general anesthesia.
  • ECOG score: 0-1.
  • Patients - can understand and are willing to take part in the clinical trial.

Exclusion Criteria:

  • Severe cardiovascular disease, uncontrollable infection or other severe complications.
  • Severe mental illness.
  • Suffer with other carcinoma simultaneously or sequentially in 5 years.
  • Familial polyposis coli or Multiple -colorectal tumor.
  • History of abdominal surgery and with severe abdominal adhesions.
  • Combine with acute intestinal obstruction, intestinal bleeding, intestinal perforation and emergency surgery is needed.
  • Multiple organs resection surgery is needed.
  • Abdominoperineal resection need to be performed.
  • ASA class: IV to V.
  • Pregnant, suckling period or reject to birth control.
  • Patient who unable to go through the clinical trial because of familial,social or religious factors.
  • Refuse to take part in the trial.
  • Patients without an informed consent.
  • Non-compliant patient
  • The patient or their family members want to withdraw from the clinical trial.
  • Loss to follow-up
  • Researchers think the participants need to withdraw from the clinical trial.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low ligation
Left colic artery (LCA) is identified, tie the sigmoid artery and superior rectal artery,Apical lymph node dissection with the left colic artery preservation is performed.
Procedure: Low ligation
Left colic artery (LCA) is identified, Tie the sigmoid artery and superior rectal artery, Apical lymph node dissection with the left colic artery preservation is performed.
Other Names:
  • LL
Active Comparator: High ligation
The IMA is ligated and divided at 2 cm from its origin. Apical lymph nodes dissection is performed.
Procedure: High ligation
The IMA is ligated and divided at 2 cm from its origin. Apicallymph nodes dissection is performed.
Other Names:
  • HL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anastomotic leakage
Time Frame: 3 months
Anastomosis leakage rate after surgery, acute or chronic
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proximal bowel necrosis
Time Frame: 3 months
Proximal bowel necrosis rate after surgery, acute or chronic
3 months
proximal bowel stenosis
Time Frame: 3 months
Proximal bowel stenosis rate after surgery, acute or chronic
3 months
Characteristics of the division branches of the inferior mesenteric artery in Chinese people
Time Frame: 1-2 days
e.g.,The distance from the left colon artery to the root of inferior mesenteric artery(cm).
1-2 days
Apical Lymph Nodes Positive Rate
Time Frame: 14 days
Apical Lymph Nodes Positive Rate
14 days
Conversion rate to laparotomy
Time Frame: 5-years
Conversion rate to laparotomy
5-years
Complications of defunctioning stoma
Time Frame: 3 months
Complications of defunctioning stoma
3 months
Early postoperative complications: Anastomotic bleeding, etc.
Time Frame: 30 days
Early postoperative complications: Anastomotic bleeding, etc.
30 days
Anastomosis stenosis rate after surgery
Time Frame: 30 days
Anastomosis stenosis rate after surgery
30 days
Mortality rate in 3 months after surgery
Time Frame: 3 months
Mortality rate in 3 months after surgery
3 months
Life quality
Time Frame: 5-years
Life quality is measured by questionnaire(EORTC QLQ-C30 (version 3)).
5-years
Micturition function scoring
Time Frame: 3 months
Micturition function is measured by questionnaire(IPSS).
3 months
Sexual function scoring
Time Frame: 3 months
Sexual function is measured by questionnaire(The IIEF-5 questionnaire).
3 months
5-years overall survival rate
Time Frame: 5-years
5-years overall survival rate
5-years
5-years disease free survival rate
Time Frame: 5-years
5-years disease free survival rate
5-years

Collaborators and Investigators

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

Sponsor

WEIDONG LIU，MD

Investigators

  • Principal Investigator: Wei dong Liu, MD, Xiangya Hospital of Central South University
  • Study Director: Xi Xie, MD, Xiangya Hospital of Central South 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 (Actual)

January 1, 2018

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

January 16, 2018

First Submitted That Met QC Criteria

April 7, 2018

First Posted (Actual)

April 17, 2018

Study Record Updates

Last Update Posted (Actual)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 7, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCRS-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

we would like to share our data.

IPD Sharing Time Frame

Around 2025

IPD Sharing Access Criteria

Someone who has the same or similar research could contact us at davidcsu@foxmail.com

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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