Clinical trial NCT04850027: MRI-guided Lateral Lymph Node Dissection in Rectal Cancer
Official title: MAgnetic Resonance Imaging Guided LAteral Lymph Node Dissection in Lower REctal Cancer - A Multicenter, Prospective, Registry Study (MALAREC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectal Cancer
Keywords: Lateral lymph node
Surgery
Magnetic resonance imaging
oncological outcome
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Shengjing Hospital
name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: West China Hospital
name: The First Affiliated Hospital of Dalian Medical University
name: China-Japan Friendship Hospital
name: Peking University First Hospital
name: Beijing Friendship Hospital
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Peking University Cancer Hospital & Institute
name: The First Hospital of Jilin University
name: China-Japan Union Hospital, Jilin University
name: Tianjin People's Hospital
name: Second Affiliated Hospital of Suzhou University
name: Peking Union Medical College Hospital
name: Ruijin Hospital
name: First Hospital of China Medical University
name: Chinese PLA General Hospital
name: Zhejiang Cancer Hospital
name: The Affiliated Hospital of Xuzhou Medical University
name: The Affiliated Hospital of Qingdao University
name: Shanghai Cancer Hospital, China
First posted: 2021-04-20
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: To investigate the oncological outcome of lateral lymph node dissection in low rectal cancer based on MRI

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.

Eligibility criteria: Inclusion Criteria:

1. Age between 18-75 years old
2. Pathologically confirmed as rectal adenocarcinoma
3. The tumor is located in the middle or lower rectum
4. Preoperative MRI assessment is T2-4 N+M0
5. Lateral lymph node short diameter ≥ 5 mm (MRI)
6. Signed informed consent

Exclusion Criteria:

1. Previous history of malignant colorectal tumors
2. Multiple abdominal or pelvic surgeries were performed
3. Complicated with bowel obstruction, perforation or bleeding
4. Patients undergoing palliative surgery
5. Patients with severe liver and kidney dysfunction, cardiopulmonary dysfunction, blood coagulation dysfunction, or combined with serious underlying diseases that cannot tolerate surgery
6. Have a history of severe mental illness
7. Pregnant or breastfeeding women （8) Patients previously treated with iliac artery surgery (or its branches)

(9) R0 resection cannot complete (10) ASA grade ≥ IV

Primary outcomes:
measure: Pathological positive rate
timeFrame: 3-year.
measure: Local recurrence rate
timeFrame: 3-year
measure: Overall survival rate
timeFrame: 3-year
measure: Disease free survival
timeFrame: 3-year
Secondary outcomes:
measure: Early morbidity rate
timeFrame: 30 days
measure: Duration of the surgery
timeFrame: 1 day
measure: Postoperative complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
state: Beijing
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Qian Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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