Predicting Complications of Hepatolithiasis After Hepatectomy

September 11, 2023 updated by: Gang Chen, MD, First Affiliated Hospital of Wenzhou Medical University

Machine Learning Algorithms Based on Clinical Data to Predict Postoperative Complications of Patients With Hepatolithiasis Undergoing Hepatectomy

Postoperative complications seriously affect the recovery of patients undergoing hepatectomy. Identifying risk factors and develop predictive models of complications for patients with hepatolithiasis undergoing hepatectomy is important for clinical practice.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Along with the change of lifestyle and dietary habits, many people are diagnosed with hepatolithiasis that is especially prevalent in Asia. Liver resection remains the favorable curative therapy for hepatolithiasis with a relatively low recurrence rate. Although there have been great improvements in surgical techniques and perioperative management, postoperative complications remain commonplace and seriously threat the recovery of patients undergoing hepatectomy. Therefore, it is important to identify risk factors of complications to improve the overall prognosis of patients. We want to collect the clinical information of patients with hepatolithiasis undergoing hepatectomy, including demographic data , laboratory index, histological features and postoperative complications. Patients are followed up at a interval of 3 month after treatment, and the survival data and recurrence rate are recorded. Then the relationship between clinical data and short-term outcomes after surgery are explored. Then models based on clinical features are developed to predict short-term outcomes after hepatectomy.

Study Type

Observational

Enrollment (Estimated)

500

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
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Gang Chen

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with hepatolithiasis who received liver resection for curative intent

Description

Inclusion Criteria:

  • pathologically diagnosed hepatolithiasis
  • without malignancies
  • receiving liver resection
  • Eastern Cooperative Oncology Group performance status (ECOG-PS) 0-2
  • Child-Pugh score of ≤7
  • complete clinical and follow-up information
  • age between 18-80 years old

Exclusion Criteria:

  • with malignancies
  • receiving other treatments
  • Eastern Cooperative Oncology Group performance status (ECOG-PS) >2
  • Child-Pugh score of >7
  • incomplete clinical data
  • lost to follow up
  • age <18 years old or >80 years old

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with postoperative complications
Patients who experienced postoperative complications were divided into the first group. The complications were defined according to the Clavien-Dindo classification system.
Diagnostic test: radiological evaluation

All patients undergoing hepatectomy receive imaging evaluation and laboratory test before and after surgery to define clinical parameters.

diseases
patients without postoperative complications
Patients who didn't experience postoperative complications were divided into the second group.
Diagnostic test: radiological evaluation

All patients undergoing hepatectomy receive imaging evaluation and laboratory test before and after surgery to define clinical parameters.

diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 3 months
Postoperative complications and mortality are recorded according to the Clavien-Dindo classification system
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of hepatolithiasis
Time Frame: 1 year
Patients were followed-up at an interval of 3 months and recurrence of hepatolithiasis is evaluated by radiological methods.
1 year

Collaborators and Investigators

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

Sponsor

First Affiliated Hospital of Wenzhou Medical University

Collaborators

Qilu Hospital of Shandong University
Eastern Hepatobiliary Surgery Hospital
The First Affiliated Hospital of Zhejiang Chinese Medical University

Investigators

  • Principal Investigator: Gang Chen, MD,PhD, First Affiliated Hospital of Wenzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 1, 2011

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

September 23, 2022

First Submitted That Met QC Criteria

September 23, 2022

First Posted (Actual)

September 27, 2022

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • prognosis of hepatolithiasis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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