MRA Diameter as a Predictor for LLN Metastasis in Rectal Cancer.

NCT07419516 | Completed

• 1 other identifier: 20251118020132592
• Study Type: observational
• Target: 690
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to identify risk factors-including clinical and imaging indicators such as middle rectal artery (MRA) diameter-that may be associated with lateral lymph node metastasis (LLNM) in rectal cancer located below the peritoneal reflection, and to construct a corresponding predictive model.The main questions it aims to answer are: What factors are associated with clinically suspected lateral lymph node metastasis in rectal cancer below the peritoneal reflection? Can an effective predictive model be constructed based on these factors? Participants' clinical information has been collected for statistical analysis.

Conditions

Rectal Neoplasms

Keywords

Rectal cancer; lateral lymph node metastasis; middle rectal artery diameter; predictive model

Outcome Measures

Primary Outcomes (1)

• Independent Risk Factors for Clinically Suspected Lateral Lymph Node Metastasis (cLLNM)

  Multivariable logistic regression analysis incorporating preoperative clinical and imaging variables to identify independent risk factors associated with clinically suspected lateral lymph node metastasis (cLLNM). Results are presented as odds ratios with 95% confidence intervals.

  At the time of preoperative assessment (Data collected retrospectively from January 2022 to December 2024).

Secondary Outcomes (2)

• Discriminative Ability for Clinically Suspected Lateral Lymph Node Metastasis Prediction

  At the time of preoperative assessment (Data collected retrospectively from January 2022 to December 2024).

• Diagnostic performance of the key predictor: middle rectal artery diameter

  At the time of preoperative assessment (Data collected retrospectively from January 2022 to December 2024).

Study Arms (2)

Clinically suspected LLNM

Patients with clinically suspected lateral lymph node metastasis.

Other: No Intervention

Clinically suspected non-LLNM

Patients without clinically suspected lateral lymph node metastasis.

Other: No Intervention

Interventions

No Intervention OTHER

This is a retrospective observational study. There is no intervention assigned as part of this research. The study involves the analysis of existing clinical data from patients who were clinically suspected of lateral lymph node metastasis (LLNM) versus those who were not. Treatments received by patients (e.g., surgery, radiotherapy) were part of their routine clinical care and are not interventions administered by this study protocol.

Clinically suspected LLNM; Clinically suspected non-LLNM

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This retrospective cohort study included adult patients (aged 18-75 years) with pathologically confirmed rectal adenocarcinoma located below the peritoneal reflection, who had complete preoperative pelvic MRI data and were treated at The First Affiliated Hospital of Fujian Medical University between 2022 and 2024. The study aimed to analyze this population to identify risk factors and develop a predictive model for clinically suspected lateral lymph node metastasis.

You may qualify if:

• Age at diagnosis between 18 and 75 years
• Pathological confirmation of rectal adenocarcinoma by endoscopic biopsy
• Imaging confirmation that the tumor was located below the peritoneal reflection
• Availability of rectal MRI scans providing detailed imaging of the pelvic region
• Received treatment at The First Affiliated Hospital of Fujian Medical University between January 2022 and December 2024

You may not qualify if:

• Pathological diagnosis of non-primary rectal malignancies
• Previous treatment for rectal cancer with chemotherapy, radiotherapy, or surgery, with the current presentation indicating recurrence
• Incomplete rectal MRI data or poor image quality affecting interpretation
• Incomplete medical or clinical records. Ultimately, 690 patients were included in the final analysis

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350004, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Yongjian Huang

  First Affiliated Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending physician

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 19, 2026
• Study Start: January 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data and supporting documents will become available upon reasonable request after the publication of the study.
• Access Criteria: Researchers who provide a methodologically sound proposal may request access to deidentified individual participant data and supporting documents. Proposals should be directed to the corresponding author at 13600801413@139.com. To gain access, requestors will need to sign a data access agreement. Approval is subject to review by the study's principal investigator and the institutional ethics committee.

Locations

CN (1)