MRI-guided Lateral Lymph Node Dissection in Rectal Cancer

Recruiting

• Conditions: Rectal Cancer
• Interventions: Procedure: TME+Lateral lymph node dissection.

• Registration Number: NCT04850027
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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.

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2021-04
• Study First Submitted: 2021-04-14
• Study First Submitted QC: 2021-04-14
• Study First Posted: 2021-04-20
• Last Update Submitted: 2021-04-22
• Last Update Posted: 2021-04-26
• Primary Completion: 2022-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 268

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lower rectal cancer patients with a LLN ≥ 5mm	TME+Lateral lymph node dissection.	Patients with lateral lymph node short diameter ≥ 5mm evaluated by MRI were included.

Primary Outcome Measures

Name	Time	Method
Overall survival rate	3-year	The proportion of patients survived after 3 years of surgery
Disease free survival	3-year	The proportion of patients with no disease recurrence and metastasis after 3 years of surgery.
Pathological positive rate	3-year.	The proportion of patients with positive lateral lymph node which was confirmed pathologically.
Local recurrence rate	3-year	The proportion of patients with local recurrence after 3 years of surgery

Secondary Outcome Measures

Name	Time	Method
Early morbidity rate	30 days	The early morbidity rate is defined as the event observed during operation and within 30 days after surgery
Duration of the surgery	1 day	The duration of time between the start and the end of the surgery.
Postoperative complications	30 days	Complications occurring within 30 days after surgery, mainly urinary and sexual functions.

Trial Locations

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College; 🇨🇳 Beijing, Beijing, China