Predicting Complications of Hepatolithiasis After Hepatectomy

• Conditions: Liver Diseases; Complication
• Interventions: Diagnostic Test: radiological evaluation

• Registration Number: NCT05556434
• Lead Sponsor: First Affiliated Hospital of Wenzhou Medical University

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.

Study Timeline

• Study Start: 2011-07-01
• Study First Submitted: 2022-09-23
• Study First Submitted QC: 2022-09-23
• Study First Posted: 2022-09-27
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with postoperative complications	radiological evaluation	Patients who experienced postoperative complications were divided into the first group. The complications were defined according to the Clavien-Dindo classification system.
patients without postoperative complications	radiological evaluation	Patients who didn't experience postoperative complications were divided into the second group.

Primary Outcome Measures

Name	Time	Method
Complications	3 months	Postoperative complications and mortality are recorded according to the Clavien-Dindo classification system

Secondary Outcome Measures

Name	Time	Method
Recurrence of hepatolithiasis	1 year	Patients were followed-up at an interval of 3 months and recurrence of hepatolithiasis is evaluated by radiological methods.

Trial Locations

Locations (1)

Gang Chen; 🇨🇳 Wenzhou, Zhejiang, China