Hepatolithiasis
Conditions
Brief summary
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
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.
Interventions
PROCEDURESimultaneous surgery
Simultaneous surgery in complicated hepatolithiasis
PROCEDUREstaged surgery
staged surgery in complicated hepatolithiasis
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Chinese PLA General Hospital
Eastern Hepatobiliary Surgery Hospital
First Affiliated Hospital of Zhongshan Medical University
Air Force Military Medical University, China
Huaxi Hospital
Tongji Hospital
Union hospital of Fujian Medical University
Southwest Hospital, China
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| residual ratio of biliary stone | 3 months | residual ratio of biliary stone diagnosed within 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative complications | 6 months | postoperative complications diagnosed within 6 months |
| residual lesions | 6 months | residual lesions diagnosed within 6 months |
| Health economics index | 3 months | Health economics index within 3 months |
| mortality | 3 months | mortality occured within 3 months |
Countries
China
Contacts
Primary ContactXiaobin Feng, MD
Outcome results
None listed