MRI-guided surgery for lymph node removal in rectal cancer
MAgnetic Resonance Imaging Guided LAteral Lymph Node Dissection in Lower REctal Cancer - A Multicenter, Prospective, Registry Study (MALAREC)
This study is testing whether using MRI to guide surgery for removing lymph nodes can improve outcomes for patients with low rectal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 268 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT04850027 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the oncological outcomes of lateral lymph node dissection in patients with low rectal cancer, utilizing preoperative MRI to identify lymph nodes of concern. A total of 268 patients with rectal adenocarcinoma will be enrolled, focusing on those with lymph nodes measuring 5mm or more in diameter. The study will monitor postoperative outcomes and adjuvant treatments based on pathological results over a five-year period, including regular follow-ups for the first five years post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with pathologically confirmed rectal adenocarcinoma and specific MRI findings.
Not a fit: Patients with severe comorbidities, previous malignancies, or those requiring palliative care may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and survival rates for patients with low rectal cancer.
How similar studies have performed: While similar approaches have been explored, this specific methodology focusing on MRI-guided dissection in this patient population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing
- Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Qian Liu, M.D. — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study coordinator: Qian Liu, M.D
- Email: fcwpumch@163.com
- Phone: 01087787110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.