MRI-guided Lateral Lymph Node Dissection in Rectal Cancer

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Rectal Cancer

Treatments: Procedure: TME+Lateral lymph node dissection.

Study type: Observational

Funder types: Other

Identifiers

NCT04850027

MALAREC

Details and patient eligibility

About

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

Full 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.

Enrollment: 268 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

268 participants in 1 patient group

Lower rectal cancer patients with a LLN ≥ 5mm

Description:

Patients with lateral lymph node short diameter ≥ 5mm evaluated by MRI were included.

Treatment:

Procedure: TME+Lateral lymph node dissection.