Liver Cirrhosis, Portal Hypertension
Conditions
Keywords
portal hypertension, Randomized clinical trial, laparoscopic, open
Brief summary
Many patients with portal hypertension require surgical treatment each year,and Hassab's operation, or esophagogastric devascularization and splenectomy, is an elective procedure. In recent years,laparoscopic esophagogastric devascularization and splenectomy has been used to treat portal hypertension. However, the potential benefits remain to be demonstrated in the context of a randomized trial. In this study, 120 patients will randomize equally receiving laparoscopic or open esophagogastric devascularization and splenectomy. Inclusion criteria included: platelet count \< 50×109/ml, esophageal and gastric varices revealed, agreeing the informed consent. PerioperativeOutcomes are: technical success, blood loose and infusion during the operation, recurrent varicose veins on gastroscopy examination, patterns of reflux on duplex ultrasound examination, complications, platelet and liver function variation, length of hospital stay. Follow-up will last 5 years, and gastroscopy and ultrasonic will perform at 3 months, 1 year, 3 years, and 5 years. Further more, this study was proved by the ethical committee of second hospital of Xi'an jiaotong university.
Interventions
PROCEDUREopen surgical procedure
open esophagogastric devascularization and splenectomy will perform as surgical procedure in the patients
PROCEDURElaparoscopic surgical procedure
laparoscopic esophagogastric devascularization and splenectomy will perform as surgical procedure in the patients
Sponsors
Second Affiliated Hospital of Xi'an Jiaotong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* The cause of portal hypertension was cirrhosis * Platelet count \< 50×109/ml * Esophageal and gastric varices revealed * Agreeing the informed consent.
Exclusion criteria
* Thrombosis present in portal vein preoperatively * Accompany with liver cancer * Operation procedure is laparoscopy converse to open * Patients disagree with the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| recurrence | 5 years | gastroesophageal varices recurrence rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| operation time | 1 day | Duration of surgical procedure |
Other
| Measure | Time frame | Description |
|---|---|---|
| blood loss during surgical procedure | 1 day | — |
| blood transfusion during surgical procedure | 1 day | — |
| survival | 5 years | record the time of death and the death reason |
| rebleeding | 1 day | record rebleeding time in each bleeding patient |
| cost of hospitalization | 4 weeks | — |
| Number of Participants with Serious and Non-Serious Adverse Events | 4 weeks | record all kind of postoperative complications in each patient |
| length of hospital stay | 4 weeks | — |
Countries
China
Contacts
Primary ContactYang Liu, Doctor
Outcome results
None listed