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

NCT03498885 | Unknown

• 1 other identifier: CCRS-1
• Study Type: interventional
• Target: 466
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Cancer

Keywords

Rectal Cancer; inferior mesenteric artery; Laparoscopic

Outcome Measures

Primary Outcomes (1)

• Anastomotic leakage

  Anastomosis leakage rate after surgery, acute or chronic

  3 months

Secondary Outcomes (14)

• proximal bowel necrosis

  3 months

• proximal bowel stenosis

  3 months

• Characteristics of the division branches of the inferior mesenteric artery in Chinese people

  1-2 days

• Apical Lymph Nodes Positive Rate

  14 days

• Conversion rate to laparotomy

  5-years

Study Arms (2)

Low ligation

EXPERIMENTAL

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

High ligation

ACTIVE COMPARATOR

The IMA is ligated and divided at 2 cm from its origin. Apical lymph nodes dissection is performed.

Procedure: High ligation

Interventions

Low ligation PROCEDURE

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.

Also known as: LL

Low ligation

High ligation PROCEDURE

The IMA is ligated and divided at 2 cm from its origin. Apicallymph nodes dissection is performed.

Also known as: HL

High ligation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• WEIDONG LIU，MD: lead

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

RECRUITING

Related Publications (21)

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MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Wei dong Liu, MD

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

• Xi Xie, MD

  Xiangya Hospital of Central South University

  STUDY DIRECTOR

Central Study Contacts

Ting Zou, MD

CONTACT

0086-15874865802; zouting218@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Department of General Surgery

Model Details: Procedure： Low ligation with apical lymph node dissection Procedure： High ligation with apical lymph node dissection

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: April 17, 2018
• Study Start: January 1, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2025
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: Around 2025
• Access Criteria: Someone who has the same or similar research could contact us at davidcsu@foxmail.com

Locations

CN (1)