Lateral Lymph Node Dissection for Middle-low Rectal Cancer

Prospective Study on Image-guided Internal Iliac Vessels Dissection and Node-for-node for Selected Lateral Lymph Node Dissection in Middles-low Rectal Cancer

The investigators will perform CT three-dimension reconstruction for middle-low rectal cancer patients who have enlarged lateral lymph nodes to recognize the variance of pelvic vessels, by which to help reduce operative time and blood loss, localize the lateral lymph nodes, improve the lymph node harvested and positive rate. Besides, The investigators will label the vessels near the interested node to achieve node-by-node for further investigation.

Study Overview

• Status: Unknown
• Conditions: Rectal Cancer
• Intervention / Treatment: Radiation: CT three-dimensional reconstruction

Detailed Description

CT three-dimensional reconstruction was performed for middle-low patients who had enlarged lateral lymph node before surgery. The main purpose is to recognize the track and variance of pelvic and iliac blood vessels. The investigators want to explore whether this method can help reduce operative time, unexpected injuries and blood loss, and The investigators also want to study whether it can help improve the lymph node harvested and positive rate during lateral lymph node dissection. Besides, The investigators want to perform node-by-node for enlarged lateral lymph node and CT three-dimensional reconstruction can help the investigators to localize and label the interested lymph node during operation. After node-by-node, The investigators can explore the accuracy of radiologists' and surgeons' judgement for lateral lymph node metastasis, and The investigators also want explore the best cut-off value of shorter diameter to predict lateral lymph node metastasis. Besides, The investigators want to perform texture analysis by combination radiology and pathology to find some useful parameters to predict lateral lymph node metastasis.

The investigators also want to explore the feasibility of dissecting the unilateral visceral branch of internal iliac vessels when performing lateral lymph node dissection.

The investigators will have a close follow-up for patients who have enlarged lateral lymph node but do not meet the criteria for lateral lymph node dissection. CT three-dimensional reconstruction can help The investigators recognize which parts' lateral lymph nodes have more potential possibility to metastasis and recurrence.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital, Sichuan University
      • Contact: Ziqiang Wang, MD; Phone Number: +8618980602028; Email: xbzhang262402@163.com
      • Principal Investigator: Xubing Zhang, MD

Participation Criteria

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) confirmed rectal cancer; 2) tumor located less than 10 cm from the anus verge; 3) have enlarged lateral lymph on preoperative CT/MRI

Exclusion Criteria: 1) patients who have severe liver or renal dysfunction;

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; All patients receive CT three-dimensional reconstruction before surgery.	Radiation: CT three-dimensional reconstruction; All patients will receive CT three dimensional reconstruction before surgery
No Intervention: control group; All patients did not receive CT three-dimensional before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss	intraoperative blood loss	2 year
operative time	including total operative time and that for lateral lymph node	2 year
lateral lymph node harvested	lateral lymph node harvested	2 year
Accuracy of judgement for lateral lymph node metastasis	including radiologists' and surgeons' accuracy	2 year
Cut-off value of shorter diameter	The best cut-off value of shorter diameter for lateral lymph node dissection	2 year
vessels variances	The blood vessels variance of internal iliac vessels	October 1. 2018-December 31.2020
postoperative complication	including urinary and sexual function	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
local recurrence rate	local recurrence rate	3 year
overall survival	overall survival	3 year
disease-free survival	disease-free survival	3 year

Collaborators and Investigators

• Sponsor: Ziqiang Wang,MD
• Investigators: Study Chair: Ziqiang Wang, MD, Department of Gastrointestinal Surgery, West China Hospital, Sichuan University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (Actual): February 1, 2019

Study Record Updates

• Last Update Posted (Actual): February 1, 2019
• Last Update Submitted That Met QC Criteria: January 30, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: rectal cancer; lateral lymph node dissection; node-by-node; CT three-dimensional reconstruction; internal iliac vessels dissection
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: LLND-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No