Skip to content

MRI-guided Lateral Lymph Node Dissection in Rectal Cancer

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04850027
Enrollment
268
Registered
2021-04-20
Start date
2021-01-01
Completion date
2025-12-31
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

Lateral lymph node, Surgery, Magnetic resonance imaging, oncological outcome

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.

Interventions

PROCEDURETME+Lateral lymph node dissection.

TME and lateral lymph node dissection is performed in rectal cancer patients with lateral lymph node short diameter ≥ 5 mm.

Sponsors

Shengjing Hospital
CollaboratorOTHER
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
CollaboratorOTHER
West China Hospital
CollaboratorOTHER
The First Affiliated Hospital of Dalian Medical University
CollaboratorOTHER
China-Japan Friendship Hospital
CollaboratorOTHER
Peking University First Hospital
CollaboratorOTHER
Beijing Friendship Hospital
CollaboratorOTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
CollaboratorOTHER
Peking University Cancer Hospital & Institute
CollaboratorOTHER
The First Hospital of Jilin University
CollaboratorOTHER
China-Japan Union Hospital, Jilin University
CollaboratorOTHER
Tianjin People's Hospital
CollaboratorOTHER
Second Affiliated Hospital of Suzhou University
CollaboratorOTHER
Peking Union Medical College Hospital
CollaboratorOTHER
Ruijin Hospital
CollaboratorOTHER
First Hospital of China Medical University
CollaboratorOTHER
Chinese PLA General Hospital
CollaboratorOTHER
Zhejiang Cancer Hospital
CollaboratorOTHER
The Affiliated Hospital of Xuzhou Medical University
CollaboratorOTHER
The Affiliated Hospital of Qingdao University
CollaboratorOTHER
Shanghai Cancer Hospital, China
CollaboratorOTHER
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Overall survival rate3-yearThe proportion of patients survived after 3 years of surgery
Pathological positive rate3-year.The proportion of patients with positive lateral lymph node which was confirmed pathologically.
Local recurrence rate3-yearThe proportion of patients with local recurrence after 3 years of surgery
Disease free survival3-yearThe proportion of patients with no disease recurrence and metastasis after 3 years of surgery.

Secondary

MeasureTime frameDescription
Duration of the surgery1 dayThe duration of time between the start and the end of the surgery.
Postoperative complications30 daysComplications occurring within 30 days after surgery, mainly urinary and sexual functions.
Early morbidity rate30 daysThe early morbidity rate is defined as the event observed during operation and within 30 days after surgery

Countries

China

Contacts

Primary ContactQian Liu, M.D
fcwpumch@163.com01087787110

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026