Clinical trial NCT05556434: Predicting Complications of Hepatolithiasis After Hepatectomy
Official title: Machine Learning Algorithms Based on Clinical Data to Predict Postoperative Complications of Patients With Hepatolithiasis Undergoing Hepatectomy
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Liver Diseases
Complication
Keywords: liver resection
complication
risk factor
machine learning
hepatolithiasis
Lead sponsor: First Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
Collaborators: name: Eastern Hepatobiliary Surgery Hospital
name: The First Affiliated Hospital of Zhejiang Chinese Medical University
name: Qilu Hospital of Shandong University
First posted: 2022-09-27
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hepatolithiasis who received liver resection for curative intent

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Complications
timeFrame: 3 months
Secondary outcomes:
measure: Recurrence of hepatolithiasis
timeFrame: 1 year
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Gang Chen
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital of Wenzhou Medical University
name: Gang Chen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.