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

NCT06290739 | Completed DMC

• 1 other identifier: JHuang886
• Study Type: observational
• Target: 483
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intrahepatic Cholangiocarcinoma; Machine Learning

Keywords

Intrahepatic Cholangiocarcinoma; machine learning; prognosis; online calculator

Outcome Measures

Primary Outcomes (1)

• Overall survival

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

  2010.01-2019.01

Secondary Outcomes (1)

• Disease free survival

  2010.01-2019.01

Study Arms (2)

Intrahepatic cholangiocarcinoma patients who underwent lymph nodes dissection

Procedure: lymph nodes dissection

Intrahepatic cholangiocarcinoma patients who didn't undergo lymph nodes dissection

Interventions

lymph nodes dissection PROCEDURE

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

Intrahepatic cholangiocarcinoma patients who underwent lymph nodes dissection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

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

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 4, 2024
• Study Start: February 7, 2024
• Primary Completion: November 20, 2024
• Study Completion: November 20, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)