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

Intrahepatic Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06290739
• Other study ID #: JHuang886
• Status: Recruiting
• Start date: February 7, 2024
• Est. completion date: March 27, 2024

Study information

• Verified date: February 2024
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 27, 2024
• Est. primary completion date: March 7, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Intrahepatic Cholangiocarcinoma
• Lymphatic Metastasis
• Machine Learning

Intervention

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

Locations

Country	Name	City	State
China	Department of Liver Surgery and Liver Transplantation Center, West China Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	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	Disease free survival	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