A Machine-learning Model to Predict Lymph Node Metastasis of Intrahepatic Cholangiocarcinoma

February 26, 2024 updated by: Jiwei Huang, West China Hospital

Development and Validation of a Machine-learning Model to Predict Lymph Node Metastasis of Intrahepatic Cholangiocarcinoma: a Retrospective Cohort Study.

The object of this study is to develop a model for prediction of lymph node metastasis among intrahepatic cholangiocarcinoma (ICC) patients. Intrahepatic cholangiocarcinoma is the second most common kind of primary liver cancer, accounting for approximately 10%-15%. There is a lack of agreement regarding the necessity of performing lymph node dissection (LND) in patients with ICC. Currently, the percentage of LND is below 50%, and the rate of sufficient LND (≥6) has plummeted to less than 20%. Consequently, a large proportion of patients are unable to acquire LN status, which hinders the following systematic treatment strategies after surgery:. Therefore, our objective is to construct a LN metastasis model utilizing machine learning techniques, including patients' clinical data and pathology information, with the goal of offering a reference for patients who have not undergone LND or have had inadequate LND.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

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

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • Department of Liver Surgery and Liver Transplantation Center, West China Hospital, Sichuan University
        • Contact:
          • fengmin Luo, Doctor
          • Phone Number: +86 028-85582944
          • Email: hxyyhfb@163.com

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The data was collected from patients who underwent curative-intent hepatectomy and were diagnosed with ICC pathologically. The data was collected from the hepato-biliary and pancreatic department of West China Hospital, SCU, between the periods of January 2010 to December 2016 and January 2019 to October 2023.

Description

Inclusion Criteria:

  • 1.Patients who were confirmed with intrahepatic cholangiocarcinoma 2. curative-intent hepatectomy 3. Without concurrent extrahepatic disease

Exclusion Criteria:

  • 1.Patients lacking complete pathology information, 2. Patients who didn't get curative resection 3.Patients with concurrent extrahepatic disease or had missing follow-up data

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intrahepatic cholangiocarcinoma patients who underwent lymph nodes dissection
Procedure: lymph nodes dissection
Whether lymph nodes dissection should be performed on curative-intent hepatectomy for intrahepatic cholangiocarcinoma is still debated.
Intrahepatic cholangiocarcinoma patients who didn't undergo lymph nodes dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 2010.01-2021.01
Overall survival (OS) refers to the duration between the commencement of surgery and the patient's demise due to any reason.
2010.01-2021.01

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival
Time Frame: 2010.01-2021.01
Disease-free survival (DFS) refers to the period of time from the date of surgery until the occurrence of a relapse either within or outside the liver.
2010.01-2021.01

Collaborators and Investigators

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

Sponsor

West China Hospital

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)

February 7, 2024

Primary Completion (Estimated)

March 7, 2024

Study Completion (Estimated)

March 27, 2024

Study Registration Dates

First Submitted

February 26, 2024

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Estimated)

March 4, 2024

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JHuang886

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data that supports the findings of this study is available from the corresponding author upon reasonable request.

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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