Lateral Lymph Node Dissection for Middle-low Rectal Cancer

Rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03826862
• Other study ID #: LLND-2018
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 30, 2022

Study information

• Verified date: January 2019
• Source: West China Hospital
• Contact: Ziqiang Wang, MD
• Phone: +8618980602028
• Email: xbzhang262402[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2022
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Radiation:
• CT three-dimensional reconstruction
All patients will receive CT three dimensional reconstruction before surgery

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Ziqiang Wang,MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operative time	including total operative time and that for lateral lymph node	2 year
Primary	Blood loss	intraoperative blood loss	2 year
Primary	lateral lymph node harvested	lateral lymph node harvested	2 year
Primary	Accuracy of judgement for lateral lymph node metastasis	including radiologists' and surgeons' accuracy	2 year
Primary	Cut-off value of shorter diameter	The best cut-off value of shorter diameter for lateral lymph node dissection	2 year
Primary	vessels variances	The blood vessels variance of internal iliac vessels	October 1. 2018-December 31.2020
Primary	postoperative complication	including urinary and sexual function	2 year
Secondary	local recurrence rate	local recurrence rate	3 year
Secondary	overall survival	overall survival	3 year
Secondary	disease-free survival	disease-free survival	3 year