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Lateral Lymph Node Dissection for Middle-low Rectal Cancer

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ClinicalTrials.gov Identifier: NCT03826862
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Ziqiang Wang,MD, West China Hospital

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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Radiation: CT three-dimensional reconstruction Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This group with intervention will be compared previous group without intervention.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. operative time [ Time Frame: 2 year ]
    including total operative time and that for lateral lymph node

  2. Blood loss [ Time Frame: 2 year ]
    intraoperative blood loss

  3. lateral lymph node harvested [ Time Frame: 2 year ]
    lateral lymph node harvested

  4. Accuracy of judgement for lateral lymph node metastasis [ Time Frame: 2 year ]
    including radiologists' and surgeons' accuracy

  5. Cut-off value of shorter diameter [ Time Frame: 2 year ]
    The best cut-off value of shorter diameter for lateral lymph node dissection

  6. vessels variances [ Time Frame: October 1. 2018-December 31.2020 ]
    The blood vessels variance of internal iliac vessels

  7. postoperative complication [ Time Frame: 2 year ]
    including urinary and sexual function


Secondary Outcome Measures :
  1. local recurrence rate [ Time Frame: 3 year ]
    local recurrence rate

  2. overall survival [ Time Frame: 3 year ]
    overall survival

  3. disease-free survival [ Time Frame: 3 year ]
    disease-free survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826862


Contacts
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Contact: Ziqiang Wang, MD +8618980602028 xbzhang262402@163.com

Locations
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China, Sichuan
West China Hospital, Sichuan University Recruiting
Chengdu, Sichuan, China, 610041
Contact: Ziqiang Wang, MD    +8618980602028    xbzhang262402@163.com   
Principal Investigator: Xubing Zhang, MD         
Sponsors and Collaborators
Ziqiang Wang,MD
Investigators
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Study Chair: Ziqiang Wang, MD Department of Gastrointestinal Surgery, West China Hospital, Sichuan University

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Responsible Party: Ziqiang Wang,MD, Clinical professor, West China Hospital
ClinicalTrials.gov Identifier: NCT03826862     History of Changes
Other Study ID Numbers: LLND-2018
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ziqiang Wang,MD, West China Hospital:
lateral lymph node dissection
node-by-node
rectal cancer
CT three-dimensional reconstruction
internal iliac vessels dissection
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Rectal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases