Prediction Model for Lateral Lymph Node Metastasis

• Conditions: Rectal Cancer
• Interventions: Procedure: lateral lymph node dissection

• Registration Number: NCT04635488
• Lead Sponsor: West China Hospital

Brief Summary

Mid to low-lying rectal cancer patient with enlarged lateral lymph node befor treatment and receiving lateral lymph node dissection would be enrolled. Radiomics parameters of lateral lymph nodes would be extracted by expert software. Then a part of the nodes would be used as the training set to build the prediction model, and the another part nodes would be used as the validation set.

Detailed Description

After performing lateral lymph node dissection for the enrolled patients, we would find the targeted lateral node which was matched with the enlarged one in imaging from the specimen. Then the nodes would be send for pathological examination. Then we would extract the radiomics parameters of the nodes from the pretreatment CT and MRI with ITK-SNAP software. According to the pathological status, lymph nodes and corresponding radiomics parameters would be divided into positive and negative groups. Then significant parameters would be selected by R software. Then the prediction model with nomogram would be developed. 70% nodes would be used for for model development and the other 30% would be used for validation.

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-13
• Study First Submitted QC: 2020-11-18
• Last Update Submitted: 2020-11-18
• Study First Posted: 2020-11-19
• Last Update Posted: 2020-11-19
• Primary Completion: 2021-06-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• middle to low-lying rectal adenocarcinoma patients with enlarged lateral lymph node ≥5mm for short diameter in CT and/or MRI

Exclusion Criteria

• other kind of rectal tumor including neuroendocrine and malignant.
• high location rectal cancer.
• recurrent rectal cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trainning group	lateral lymph node dissection	70% of the whole participants would be randomly divided into the training group to build the predicition model.
validation group	lateral lymph node dissection	30% of the whole participant would be divided into the validation group to validate the model

Primary Outcome Measures

Name	Time	Method
metastasis rate of lateral lymph node	2020.1-2022.12.31

Trial Locations

Locations (1)

Guoxue Road 37#,West China Hospital; 🇨🇳 Chengdu, Sichuan, China