MRI-guided Lateral Lymph Node Dissection in Rectal Cancer

April 22, 2021 updated by: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

268

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
        • Contact:
        • Contact:
        • Principal Investigator:
          • Qian Liu, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Lower rectal cancer patients with lateral lymph node short diameter ≥ 5 mm were included in the study. TME with lateral lymph node dissection was performed in these patients. LLN positive rate, local recurrence rate, 3-year overall survival rate, perioperative complication rate and quality of life were documented and analysed.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lower rectal cancer patients with a LLN ≥ 5mm
Patients with lateral lymph node short diameter ≥ 5mm evaluated by MRI were included.
Procedure: TME+Lateral lymph node dissection.
TME and lateral lymph node dissection is performed in rectal cancer patients with lateral lymph node short diameter ≥ 5 mm.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborators

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

Investigators

  • Principal Investigator: Qian Liu, M.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

April 14, 2021

First Submitted That Met QC Criteria

April 14, 2021

First Posted (Actual)

April 20, 2021

Study Record Updates

Last Update Posted (Actual)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MALAREC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The data are available from Qian Liu upon request.

IPD Sharing Time Frame

The data were available to all the researchers permanently after this study was done.

IPD Sharing Access Criteria

All the data will be available to all the relevant researchers in the world upon request. Email: liuqianncc@126.com

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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