MRI-guided Lateral Lymph Node Dissection in Rectal Cancer

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    268
  • sponsor
    Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Updated on 7 May 2021

Summary

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

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.

Details
Condition Colorectal Cancer, Colorectal Cancer, Colon Cancer Screening, Colon cancer; rectal cancer, Rectal Cancer, Rectal Cancer, Colon Cancer Screening, Colon cancer; rectal cancer, rectal carcinoma
Treatment TME+Lateral lymph node dissection.
Clinical Study IdentifierNCT04850027
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
Last Modified on7 May 2021

Eligibility

Yes No Not Sure

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
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