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
-
-
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.
|
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.
|
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.
Collaborators
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
- Jarnagin WR, Gonen M, Fong Y, DeMatteo RP, Ben-Porat L, Little S, Corvera C, Weber S, Blumgart LH. Improvement in perioperative outcome after hepatic resection: analysis of 1,803 consecutive cases over the past decade. Ann Surg. 2002 Oct;236(4):397-406; discussion 406-7. doi: 10.1097/01.SLA.0000029003.66466.B3.
- Yang T, Lau WY, Lai EC, Yang LQ, Zhang J, Yang GS, Lu JH, Wu MC. Hepatectomy for bilateral primary hepatolithiasis: a cohort study. Ann Surg. 2010 Jan;251(1):84-90. doi: 10.1097/SLA.0b013e3181b2f374.
- Su CH, Shyr YM, Lui WY, P'Eng FK. Hepatolithiasis associated with cholangiocarcinoma. Br J Surg. 1997 Jul;84(7):969-73. doi: 10.1002/bjs.1800840717.
- Tabrizian P, Jibara G, Shrager B, Schwartz ME, Roayaie S. Hepatic resection for primary hepatolithiasis: a single-center Western experience. J Am Coll Surg. 2012 Nov;215(5):622-6. doi: 10.1016/j.jamcollsurg.2012.07.005. Epub 2012 Aug 24.
- Citterio D, Facciorusso A, Sposito C, Rota R, Bhoori S, Mazzaferro V. Hierarchic Interaction of Factors Associated With Liver Decompensation After Resection for Hepatocellular Carcinoma. JAMA Surg. 2016 Sep 1;151(9):846-53. doi: 10.1001/jamasurg.2016.1121.
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
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
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