MRI-guided Lateral Lymph Node Dissection in Rectal Cancer
April 22, 2021 updated by: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
MAgnetic Resonance Imaging Guided LAteral Lymph Node Dissection in Lower REctal Cancer - A Multicenter, Prospective, Registry Study (MALAREC)
To investigate the oncological outcome of lateral lymph node dissection in low rectal cancer based on MRI
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Our study design is a multicenter, prospective, registry study.
We would enroll 268 patients with lower rectal cancer whose preoperative MRI showed laterally lymph node diameter ≥ 5mm.
The postoperative adjuvant chemoradiotherapy is determined by the pathological results. For patients of stage II and patients of stage III with unfavorable histologic features, six months of adjuvant chemotherapy of fluorouracil-based regimen with radiotherapy of 45.0 ~ 50.5 Gy are recommended.
The postoperative examination should be performed every three months in the first two years and every six months in the following three years.
Our study is expected to last five years, of which two years for recruiting patients, three years for follow-up.
Study Type
Observational
Enrollment (Anticipated)
268
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Qian Liu, M.D
- Phone Number: 01087787110
- Email: fcwpumch@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100021
- Recruiting
- Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
-
Contact:
- Qian Liu, M.D
- Phone Number: 01087787110
- Email: fcwpumch@163.com
-
Contact:
- Zheng Liu, M.D
- Phone Number: 01087787111
- Email: 190977026@qq.com
-
Principal Investigator:
- Qian Liu, M.D
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Lower rectal cancer patients with lateral lymph node short diameter ≥ 5 mm were included in the study.
TME with lateral lymph node dissection was performed in these patients.
LLN positive rate, local recurrence rate, 3-year overall survival rate, perioperative complication rate and quality of life were documented and analysed.
Description
Inclusion Criteria:
- Age between 18-75 years old
- Pathologically confirmed as rectal adenocarcinoma
- The tumor is located in the middle or lower rectum
- Preoperative MRI assessment is T2-4 N+M0
- Lateral lymph node short diameter ≥ 5 mm (MRI)
- Signed informed consent
Exclusion Criteria:
- Previous history of malignant colorectal tumors
- Multiple abdominal or pelvic surgeries were performed
- Complicated with bowel obstruction, perforation or bleeding
- Patients undergoing palliative surgery
- Patients with severe liver and kidney dysfunction, cardiopulmonary dysfunction, blood coagulation dysfunction, or combined with serious underlying diseases that cannot tolerate surgery
- Have a history of severe mental illness
- Pregnant or breastfeeding women （8) Patients previously treated with iliac artery surgery (or its branches)
(9) R0 resection cannot complete (10) ASA grade ≥ IV
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Lower rectal cancer patients with a LLN ≥ 5mm
Patients with lateral lymph node short diameter ≥ 5mm evaluated by MRI were included.
|
TME and lateral lymph node dissection is performed in rectal cancer patients with lateral lymph node short diameter ≥ 5 mm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pathological positive rate
Time Frame: 3-year.
|
The proportion of patients with positive lateral lymph node which was confirmed pathologically.
|
3-year.
|
|
Local recurrence rate
Time Frame: 3-year
|
The proportion of patients with local recurrence after 3 years of surgery
|
3-year
|
|
Overall survival rate
Time Frame: 3-year
|
The proportion of patients survived after 3 years of surgery
|
3-year
|
|
Disease free survival
Time Frame: 3-year
|
The proportion of patients with no disease recurrence and metastasis after 3 years of surgery.
|
3-year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Early morbidity rate
Time Frame: 30 days
|
The early morbidity rate is defined as the event observed during operation and within 30 days after surgery
|
30 days
|
|
Duration of the surgery
Time Frame: 1 day
|
The duration of time between the start and the end of the surgery.
|
1 day
|
|
Postoperative complications
Time Frame: 30 days
|
Complications occurring within 30 days after surgery, mainly urinary and sexual functions.
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Qian Liu, M.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Baik SH, Kim NK, Lee YC, Kim H, Lee KY, Sohn SK, Cho CH. Prognostic significance of circumferential resection margin following total mesorectal excision and adjuvant chemoradiotherapy in patients with rectal cancer. Ann Surg Oncol. 2007 Feb;14(2):462-9. doi: 10.1245/s10434-006-9171-0. Epub 2006 Nov 10.
- Akiyoshi T, Ueno M, Matsueda K, Konishi T, Fujimoto Y, Nagayama S, Fukunaga Y, Unno T, Kano A, Kuroyanagi H, Oya M, Yamaguchi T, Watanabe T, Muto T. Selective lateral pelvic lymph node dissection in patients with advanced low rectal cancer treated with preoperative chemoradiotherapy based on pretreatment imaging. Ann Surg Oncol. 2014 Jan;21(1):189-96. doi: 10.1245/s10434-013-3216-y. Epub 2013 Aug 21.
- Fujita S, Mizusawa J, Kanemitsu Y, Ito M, Kinugasa Y, Komori K, Ohue M, Ota M, Akazai Y, Shiozawa M, Yamaguchi T, Bandou H, Katsumata K, Murata K, Akagi Y, Takiguchi N, Saida Y, Nakamura K, Fukuda H, Akasu T, Moriya Y; Colorectal Cancer Study Group of Japan Clinical Oncology Group. Mesorectal Excision With or Without Lateral Lymph Node Dissection for Clinical Stage II/III Lower Rectal Cancer (JCOG0212): A Multicenter, Randomized Controlled, Noninferiority Trial. Ann Surg. 2017 Aug;266(2):201-207. doi: 10.1097/SLA.0000000000002212.
- Ishihara S, Kawai K, Tanaka T, Kiyomatsu T, Hata K, Nozawa H, Morikawa T, Watanabe T. Oncological Outcomes of Lateral Pelvic Lymph Node Metastasis in Rectal Cancer Treated With Preoperative Chemoradiotherapy. Dis Colon Rectum. 2017 May;60(5):469-476. doi: 10.1097/DCR.0000000000000752.
- Furuhata T, Okita K, Nishidate T, Ito T, Yamaguchi H, Ueki T, Akizuki E, Meguro M, Ogawa T, Kukita K, Kimura Y, Mizuguchi T, Hirata K. Clinical feasibility of laparoscopic lateral pelvic lymph node dissection following total mesorectal excision for advanced rectal cancer. Surg Today. 2015 Mar;45(3):310-4. doi: 10.1007/s00595-014-0906-4. Epub 2014 May 3.
- Zhou S, Tang J, Liang J, Lou Z, Fu W, Feng B, Yang Y, Xiao Y, Liu Q. Effective dissecting range and prognostic significance of lateral pelvic lymph node dissection for middle-low rectal cancer patients with lateral pelvic lymph node metastasis: Results of a large multicenter lateral node collaborative group in China. Front Oncol. 2022 Aug 12;12:916285. doi: 10.3389/fonc.2022.916285. eCollection 2022.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
December 31, 2025
Study Registration Dates
First Submitted
April 14, 2021
First Submitted That Met QC Criteria
April 14, 2021
First Posted (Actual)
April 20, 2021
Study Record Updates
Last Update Posted (Actual)
April 26, 2021
Last Update Submitted That Met QC Criteria
April 22, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MALAREC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
The data are available from Qian Liu upon request.
IPD Sharing Time Frame
The data were available to all the researchers permanently after this study was done.
IPD Sharing Access Criteria
All the data will be available to all the relevant researchers in the world upon request.
Email: liuqianncc@126.com
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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