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Lateral Lymph Node Dissection for Middle-low Rectal Cancer

Primary Purpose

Rectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CT three-dimensional reconstruction
Sponsored by
Ziqiang Wang,MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring lateral lymph node dissection, node-by-node, rectal cancer, CT three-dimensional reconstruction, internal iliac vessels dissection

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • West China Hospital, Sichuan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention group

control group

Arm Description

All patients receive CT three-dimensional reconstruction before surgery.

All patients did not receive CT three-dimensional before surgery

Outcomes

Primary Outcome Measures

operative time
including total operative time and that for lateral lymph node
Blood loss
intraoperative blood loss
lateral lymph node harvested
lateral lymph node harvested
Accuracy of judgement for lateral lymph node metastasis
including radiologists' and surgeons' accuracy
Cut-off value of shorter diameter
The best cut-off value of shorter diameter for lateral lymph node dissection
vessels variances
The blood vessels variance of internal iliac vessels
postoperative complication
including urinary and sexual function

Secondary Outcome Measures

local recurrence rate
local recurrence rate
overall survival
overall survival
disease-free survival
disease-free survival

Full Information

First Posted
January 25, 2019
Last Updated
January 30, 2019
Sponsor
Ziqiang Wang,MD
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1. Study Identification

Unique Protocol Identification Number
NCT03826862
Brief Title
Lateral Lymph Node Dissection for Middle-low Rectal Cancer
Official Title
Prospective Study on Image-guided Internal Iliac Vessels Dissection and Node-for-node for Selected Lateral Lymph Node Dissection in Middles-low Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ziqiang Wang,MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
lateral lymph node dissection, node-by-node, rectal cancer, CT three-dimensional reconstruction, internal iliac vessels dissection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This group with intervention will be compared previous group without intervention.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
All patients receive CT three-dimensional reconstruction before surgery.
Arm Title
control group
Arm Type
No Intervention
Arm Description
All patients did not receive CT three-dimensional before surgery
Intervention Type
Radiation
Intervention Name(s)
CT three-dimensional reconstruction
Intervention Description
All patients will receive CT three dimensional reconstruction before surgery
Primary Outcome Measure Information:
Title
operative time
Description
including total operative time and that for lateral lymph node
Time Frame
2 year
Title
Blood loss
Description
intraoperative blood loss
Time Frame
2 year
Title
lateral lymph node harvested
Description
lateral lymph node harvested
Time Frame
2 year
Title
Accuracy of judgement for lateral lymph node metastasis
Description
including radiologists' and surgeons' accuracy
Time Frame
2 year
Title
Cut-off value of shorter diameter
Description
The best cut-off value of shorter diameter for lateral lymph node dissection
Time Frame
2 year
Title
vessels variances
Description
The blood vessels variance of internal iliac vessels
Time Frame
October 1. 2018-December 31.2020
Title
postoperative complication
Description
including urinary and sexual function
Time Frame
2 year
Secondary Outcome Measure Information:
Title
local recurrence rate
Description
local recurrence rate
Time Frame
3 year
Title
overall survival
Description
overall survival
Time Frame
3 year
Title
disease-free survival
Description
disease-free survival
Time Frame
3 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ziqiang Wang, MD
Phone
+8618980602028
Email
xbzhang262402@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziqiang Wang, MD
Organizational Affiliation
Department of Gastrointestinal Surgery, West China Hospital, Sichuan University
Official's Role
Study Chair
Facility Information:
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziqiang Wang, MD
Phone
+8618980602028
Email
xbzhang262402@163.com
First Name & Middle Initial & Last Name & Degree
Xubing Zhang, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Lateral Lymph Node Dissection for Middle-low Rectal Cancer

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