MRI-guided Lateral Lymph Node Dissection in Rectal Cancer

Study Overview
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Brief Summary
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To investigate the oncological outcome of lateral lymph node dissection in low rectal cancer based on MRI

Detailed Description
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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.

Official Title
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MAgnetic Resonance Imaging Guided LAteral Lymph Node Dissection in Lower REctal Cancer - A Multicenter, Prospective, Registry Study (MALAREC)

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: TME+Lateral lymph node dissection.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lower rectal cancer patients with a LLN ≥ 5mm<br>Patients with lateral lymph node short diameter ≥ 5mm evaluated by MRI were included. | Procedure: TME+Lateral lymph node dissection.<br>* TME and lateral lymph node dissection is performed in rectal cancer patients with lateral lymph node short diameter ≥ 5 mm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological positive rate | The proportion of patients with positive lateral lymph node which was confirmed pathologically. | 3-year. | 
| Local recurrence rate | The proportion of patients with local recurrence after 3 years of surgery | 3-year | 
| Overall survival rate | The proportion of patients survived after 3 years of surgery | 3-year | 
| Disease free survival | 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 | The early morbidity rate is defined as the event observed during operation and within 30 days after surgery | 30 days | 
| Duration of the surgery | The duration of time between the start and the end of the surgery. | 1 day | 
| Postoperative complications | Complications occurring within 30 days after surgery, mainly urinary and sexual functions. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lateral lymph node, Surgery, Magnetic resonance imaging, oncological outcome