Rectal CancerNCT03826862
Lateral Lymph Node Dissection for Middle-low Rectal Cancer
A study testing CT three-dimensional reconstruction in people with Rectal Cancer, run by Ziqiang Wang,MD at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- CT three-dimensional reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2018to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Ziqiang Wang, MD, +8618980602028, xbzhang262402@163.com
Xubing Zhang, MD
About this study
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
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.
Read the 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.
- Conditions
- Rectal Cancer
- Being tested
- CT three-dimensional reconstruction
- Keywords
- lateral lymph node dissection, node-by-node, rectal cancer, CT three-dimensional reconstruction, internal iliac vessels dissection
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT three-dimensional reconstructionRadiation
All patients will receive CT three dimensional reconstruction before surgery
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | All patients receive CT three-dimensional reconstruction before surgery. Receives: Radiation: CT three-dimensional reconstruction |
| control group | No intervention | All patients did not receive CT three-dimensional before surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative time
including total operative time and that for lateral lymph node
Measured: 2 year
Blood loss
intraoperative blood loss
Measured: 2 year
lateral lymph node harvested
lateral lymph node harvested
Measured: 2 year
Accuracy of judgement for lateral lymph node metastasis
including radiologists' and surgeons' accuracy
Measured: 2 year
Cut-off value of shorter diameter
The best cut-off value of shorter diameter for lateral lymph node dissection
Measured: 2 year
vessels variances
The blood vessels variance of internal iliac vessels
Measured: October 1. 2018-December 31.2020
postoperative complication
including urinary and sexual function
Measured: 2 year
Secondary outcomes (3)
local recurrence rate
local recurrence rate
Measured: 3 year
overall survival
overall survival
Measured: 3 year
disease-free survival
disease-free survival
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start1 Oct 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This group with intervention will be compared previous group without intervention.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziqiang Wang,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ziqiang Wang,MD, West China Hospital
- Investigators
- Ziqiang Wang, MD, Study chair, Department of Gastrointestinal Surgery, West China Hospital, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826862
- Sponsor's protocol ID
- LLND-2018
- Status last verified
- Jan 2019
- First submitted
- 25 Jan 2019
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03826862
- Acronym / sponsor ID
- LLND-2018
- Conditions
- Rectal Cancer
- Keywords
- lateral lymph node dissection, node-by-node, rectal cancer, CT three-dimensional reconstruction, internal iliac vessels dissection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ziqiang Wang,MDUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This group with intervention will be compared previous group without intervention.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Radiation: CT three-dimensional reconstructionAll patients receive CT three-dimensional reconstruction before surgery. |
| control group | No intervention | –All patients did not receive CT three-dimensional before surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT three-dimensional reconstructionAll patients will receive CT three dimensional reconstruction before surgery | Radiation | intervention group |
Primary outcome
operative time
Time frame: 2 year
including total operative time and that for lateral lymph node
Blood loss
Time frame: 2 year
intraoperative blood loss
lateral lymph node harvested
Time frame: 2 year
lateral lymph node harvested
Accuracy of judgement for lateral lymph node metastasis
Time frame: 2 year
including radiologists' and surgeons' accuracy
Cut-off value of shorter diameter
Time frame: 2 year
The best cut-off value of shorter diameter for lateral lymph node dissection
vessels variances
Time frame: October 1. 2018-December 31.2020
The blood vessels variance of internal iliac vessels
postoperative complication
Time frame: 2 year
including urinary and sexual function
3 secondary outcomes
local recurrence rate
Time frame: 3 year
overall survival
Time frame: 3 year
disease-free survival
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Rectal Cancer
RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Hepatocellular Carcinoma (HCC), Metastatic Uveal Melanoma
Recruiting
Family Communications After Genetic Testing
Colon Adenocarcinoma, Colorectal Adenocarcinoma
Not yet recruitingPhase 1/2
Arginine-Restricted Diet Combined With Chemoradiotherapy in Neoadjuvant Rectal Cancer: A Phase Ib/II Trial
Rectal Cancer Patients
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingPhase 3
GFH375 Plus Cetuximab vs Investigator's Choice of Treatment in KRAS G12D-Mutant Refractory Metastatic Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ziqiang Wang, MD study chair
Department of Gastrointestinal Surgery, West China Hospital, Sichuan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT three-dimensional reconstruction in people with Rectal Cancer, run by Ziqiang Wang,MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ziqiang Wang, MD (+8618980602028, xbzhang262402@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operative time (time frame: 2 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.