Cirrhosis, Gastroesophageal Varices
Conditions
Keywords
HVPG
Brief summary
The purpose of the study is to compare the effect of HVPG-guided individualized therapy and non-HVPG guided traditional therapy in cirrhotic patients for secondary prophylaxis.
Detailed description
The study is a randomized controlled trial of Zelen-design. Patients randomly enter two treatment groups: 1) the HVPG group and 2) the non-HVPG group. Treatment allocation is by block randomization with an equal number for both groups. The results are concealed in opaque envelopes.After randomization, patients will have a second chance to decide if they want to stay in the current group.Patients can switch to another group according to their will. If they are in the HVPG group，they will receive HVPG measurement before treatment. If they are in the non-HVPG group, they start treatment without HVPG measurement and receive endoscopic treatment plus Carvedilol.The mortality rate and rebleeding rate will be analyzed.
Interventions
PROCEDUREHVPG-guided therapy
Patients with an HVPG over 20mmHg will be suggested to receive transjugular intrahepatic portocaval shunt (TIPS) or surgical shunt operation. Patients with an HVPG between 16 and 20mmHg can choose either endoscopic treatment or TIPS according their willingness and indication. Patients with an HVPG below 16mmHg will be treated by endoscopy plus Carvedilol, until endoscopic treatment fails.
OTHERroutine therapy
Patients start treatment without HVPG measurement and receive endoscopic therapy plus Carvedilol.
DRUGCarvedilol
Patients in HVPG group with HVPG below 16mmHg and all patients in non-HVPG group will take Carvedilol 12.5mg/d if they have no contraindications.
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Public Health Clinical Center
ShuGuang Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Pudong New Area Gongli Hospital
Eastern Hepatobiliary Surgery Hospital
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients with cirrhosis diagnosed by histology, radiological evidence of cirrhosis, and endoscopic evidence of varices; * Patients with a previous history of variceal hemorrhage; * Patients admitted to Zhongshan Hospital and other 6 tertiary centers in Shanghai from Dec 1, 2015 to Sep 31,2018
Exclusion criteria
* Patients already taken secondary prophylactic treatment including endoscopic, pharmacological, surgical and interventional therapies; * Patients with severe systemic diseases such as chronic heart failure or chronic renal failure that will have impact on survival; * Patients in pregnancy and lactation; * Patients already diagnosed with hepatic cellular carcinoma or other malignant tumors; * Patients with contraindication to treatment of endoscopy, surgery and TIPS: severe coagulation defects, allergic to contrast medium used in TIPS, hepatic encephalopathy, spontaneous bacterial peritonitis; * Patients with conditions that will influence the accuracy of HVPG measurement: Cavernous transformation of portal vein, diffused portal vein thrombosis, severe shunt; * Patients refuse to give consent to the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality rate | through study completion, an average of 1 year | The investigators observe the mortality events in both groups during the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rebleeding rate | through study completion, an average of 1 year | The investigators observe the rebleeding events in both groups during the study |
| Adverse Events | through study completion, an average of 1 year | The investigators observe any severe adverse events caused by HVPG measurement, endoscopic procedures,use of Carvedilol, surgical operations or TIPS |
| Total cost | through study completion, an average of 1 year | The investigators calculate the total cost of treatment of each patient during the study |
Countries
China
Contacts
Primary ContactShiyao Chen, Professor
Outcome results
None listed