Low or High Ligation of the IMA With Apical Lymph Node Dissection in Rectal Cancer Laparoscopic Surgery

NCT03013153 | Unknown DMC

• 1 other identifier: LAND
• Study Type: interventional
• Target: 748
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopy colon surgery is accepted worldwide in the recent years. But there is still argument on the effect of laparoscopy rectal surgery. Laparoscopy has advantages on showing the inferior mesenteric artery (IMA), protection of autonomic nerve, low rectal anastomosis, and total mesorectum excision. However, debate on the level of IMA ligation and debonding of splenic flexure never ends. This study is going to give a clear and definite answer to how and why surgeons should deal with the IMA in laparoscopy rectal surgery，base on the 3D reconstruction of IMA and identification of IMA perfusion types.

Conditions

Rectal Cancer

Keywords

Rectal Cancer; Inferior Mesenteric Artery; Ligation; Apical Lymph Nodes; Laparoscopy; IMA Types

Outcome Measures

Primary Outcomes (1)

• 5-years overall survival rate

  5-years overall survival rate

  5 years

Secondary Outcomes (23)

• 5-years disease free survival rate

  5 years

• 1-year overall survival rate

  1 year

• 1-year disease free survival rate

  1 year

• Anastomosis leakage rate

  6 months

• Apical Lymph Nodes (LN) Positive Rate

  1 week

Study Arms (2)

Low ligation with apical lymph node dissection

EXPERIMENTAL

Left colic artery (LCA) is identified according to the CT 3D-reconstruction, tie the sigmoid artery and superior rectal artery, preserved LCA while low ligation of the inferior mesenteric artery is performed. Lymphadenectomy to the apical lymph nodes (No.253)is performed around the IMA until 2 cm from the aorta. The inferior mesenteric vein (IMV) is divided and ligated below the pancreatic margin.

Procedure: Low ligation with apical lymph node dissection

High ligation

ACTIVE COMPARATOR

Open the peritoneum proceeds cephalad towards the duodenojejunal angle of Treitz, and the mesenteric root is incised 1 cm below the inferior margin of the pancreas. The aortomesenteric window is opened wide and the inferior mesenteric vessels are exposed. The IMA is ligated and divided at 2 cm from its origin. The inferior mesenteric vein (IMV) is divided and ligated below the pancreatic margin.

Procedure: High ligation

Interventions

Low ligation with apical lymph node dissection PROCEDURE

Low ligation with apical lymph node dissection (LAND). Left colic artery (LCA) is identified according to the CT 3D-reconstruction, tie the sigmoid artery and superior rectal artery, preserved LCA while low ligation of the inferior mesenteric artery is performed. Lymphadenectomy to the apical lymph nodes (No.253)is performed around the IMA until 2 cm from the aorta.

Also known as: LAND

Low ligation with apical lymph node dissection

High ligation PROCEDURE

High ligation (HL) Open the peritoneum proceeds cephalad towards the duodenojejunal angle of Treitz, and the mesenteric root is incised 1 cm below the inferior margin of the pancreas. The aortomesenteric window is opened wide and the inferior mesenteric vessels are exposed. The IMA is ligated and divided at 2 cm from its origin. The inferior mesenteric vein (IMV) is divided and ligated below the pancreatic margin.

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:

• Pathology shows rectal or sigmoid adenocarcinoma
• The bottom edge of tumor to anuas is less than 15cm
• The clinical staging of tumor by American Joint Committee on Cancer (AJCC) within T2-4 or N1-2
• Receive or not receive neoadjuvant chemotherapy based on 5-fluorouracil before surgery
• Racial resection in available after neoadjuvant chemotherapy
• No metastasis evidence was found
• Annual preservation surgery is available
• Tolerate to general anesthesia
• Eastern Cooperative Oncology Group (ECOG) status score between 0 and 1
• Patients and general anesthesia can understand the clinical trail well and are willing to take part in

You may not qualify if:

• Suffer with other carcinoma synchronous or metachronous in 5 years
• Multiple primary colon carcinoma
• Radiation therapy was performed before surgery
• History of colorectal surgery
• Combine with acute intestinal obstruction, intestinal bleeding, intestinal perforation and emergency surgery is needed
• Multiple organs resection surgery is needed
• Abdominal perineal resection is performed
• American Society of Anesthesiologists score stage IV to V
• Pregnant, suckling period or reject to contraception
• Severe cardiovascular disease, uncontrollable infection or other severe complication
• Severe mental illness
• Unable to go through the treatment because of family, society or regional condition
• Refuse to take part in the trail

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The sixth affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

Related Publications (23)

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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

• Meijin Huang, MD

  The Sixth Affiliated Hospital, Sun Yat-sen University

  STUDY DIRECTOR

Central Study Contacts

Jiaming Zhou, MD

CONTACT

+8613560031075; cysums03@163.com

Meijin Huang, MD

CONTACT

+8613924073322; 13924073322@139.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2016
• First Posted: January 6, 2017
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2023
• Last Updated: January 12, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)