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Completed

NCT Number: NCT06290739

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

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.

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Key information

Conditions

Intrahepatic Cholangiocarcinoma Adenocarcinoma Carcinoma Cholangiocarcinoma Machine Learning Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Liver Surgery and Liver Transplantation Center, West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

lymph nodes dissection

Procedure

Whether lymph nodes dissection should be performed on curative-intent hepatectomy for intrahepatic cholangiocarcinoma is still debated.

Primary outcomes

  1. Overall survival

    Time frame: 2010.01-2019.01

    Overall survival (OS) refers to the duration between the commencement of surgery and the patient's demise due to any reason.

Secondary outcomes

  1. Disease free survival

    Time frame: 2010.01-2019.01

    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.

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 4, 2024
Registry last updated
Nov 22, 2024

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.

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