Skip to main content
OpenTrials
Completed

NCT Number: NCT07419516

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350004, China

About this study

Objective: This study aimed to investigate the risk factors for suspected lateral lymph node metastasis in rectal cancer below the peritoneal reflection and to construct a predictive model.

Methods: This retrospective study analyzed data from 690 patients with rectal cancer below the peritoneal reflection who were treated at the First Affiliated Hospital of Fujian Medical University between January 2022 and December 2024. The original dataset was randomly divided into a training set and validation set at a ratio of 7:3. Univariate and multivariate logistic regression analyses were performed on the training set to identify the risk factors associated with clinical lateral lymph node (cLLN) metastasis and to construct a predictive model.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Discriminative Ability for Clinically Suspected Lateral Lymph Node Metastasis Prediction

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

    Assessment of the multivariable predictive model's discriminative performance in identifying patients with clinically suspected lateral lymph node metastasis (cLLNM). The model incorporates preoperative clinical and imaging variables, and its performance is quantified using the area under the receiver operating characteristic curve.

  2. Diagnostic performance of the key predictor: middle rectal artery diameter

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

    Sensitivity, specificity, accuracy, and optimal cutoff value (≥3.25 mm) of MRA diameter alone for identifying cLLNM.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Fujian Medical University

Other

Registry information

Official study title

Middle Rectal Artery Diameter as a Predictor for Lateral Lymph Node Metastasis in Rectal Cancer: A Predictive Model for Surgical Decision-Making.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.