Predicting Complications of Hepatolithiasis After Hepatectomy

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05556434
• Other study ID #: prognosis of hepatolithiasis
• Status: Enrolling by invitation
• Start date: July 1, 2011
• Est. completion date: July 1, 2024

Study information

• Verified date: September 2023
• Source: First Affiliated Hospital of Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Complication
• Liver Diseases

Intervention

Diagnostic Test:
• radiological evaluation
All patients undergoing hepatectomy receive imaging evaluation and laboratory test before and after surgery to define clinical parameters. diseases

Locations

Country	Name	City	State
China	Gang Chen	Wenzhou	Zhejiang

Sponsors (4)

Lead Sponsor	Collaborator
First Affiliated Hospital of Wenzhou Medical University	Eastern Hepatobiliary Surgery Hospital, Qilu Hospital of Shandong University, The First Affiliated Hospital of Zhejiang Chinese Medical University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications	Postoperative complications and mortality are recorded according to the Clavien-Dindo classification system	3 months
Secondary	Recurrence of hepatolithiasis	Patients were followed-up at an interval of 3 months and recurrence of hepatolithiasis is evaluated by radiological methods.	1 year