Safety and Efficacy of Simultaneous or Staged Surgery on Complicated Hepatolithiasis

Study Overview
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Brief Summary
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For some complicated hepatolithiasis, it is difficult to decide whether to perform surgery on biliary stone and portal hypertension simultaneously or separately by staged surgery.There's a high risk of intraoperative bleeding, postoperative liver failure and variceal bleeding for these patients.How to develop a optimized algorism of simultaneous and staged surgery is highly needed.

Detailed Description
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For some complicated hepatolithiasis, it is difficult to decide whether to perform surgery on biliary stone and portal hypertension simultaneously or separately by staged surgery.There's a high risk of intraoperative bleeding, postoperative liver failure and variceal bleeding for these patients.How to develop a optimized algorism of simultaneous and staged surgery is highly needed. In this protocol, we will assign the eligible cases into two group. And then perform surgery as simultaneously or separately.By long-term follow-up,to examine the safety and advantages of each procedure.

Official Title
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A Cohort Study on Safety and Efficacy of Simultaneous or Staged Surgery in Complicated Hepatolithiasis

Conditions
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Hepatolithiasis

Intervention / Treatment
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* Procedure: Simultaneous surgery
* Procedure: staged surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged from 18 to 65 years old Without gender restriction With a favorable liver function of Child-Pugh A to B No contraindications to surgery and anesthesia Diagnosed with Hepatolithiasis and portal hypertension Signed informed consent. Exclusion Criteria: Diffused type of Hepatolithiasis Impairment in liver function Severe disorders in vital organ Accompanied with tumors.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simultaneous surgery<br>to perform surgery both on biliary stone and portal hypertension | Procedure: Simultaneous surgery<br>* Simultaneous surgery in complicated hepatolithiasis<br>|
| Active Comparator: Staged surgery<br>to perform surgery on biliary stone and portal hypertension by staged surgery | Procedure: staged surgery<br>* staged surgery in complicated hepatolithiasis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| residual ratio of biliary stone | residual ratio of biliary stone diagnosed within 3 months | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications | postoperative complications diagnosed within 6 months | 6 months | 
| residual lesions | residual lesions diagnosed within 6 months | 6 months | 
| Health economics index | Health economics index within 3 months | 3 months | 
| mortality | mortality occured within 3 months | 3 months |