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Clinical Trials/NCT06290739
NCT06290739CompletedNot Applicable

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

West China Hospital1 site in 1 country483 target enrollmentStarted: February 7, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
483
Locations
1
Primary Endpoint
Overall survival

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

  • Disease free survival(2010.01-2019.01)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jiwei Huang

Dr.

Sichuan University

Study Sites (1)

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