The Effect of Hepatic Vein Pressure Gradient(HVPG)-Guided Therapy in Cirrhotic Patients With Esophagogastric Varices
NCT ID: NCT02638415
Last Updated: 2015-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
500 participants
INTERVENTIONAL
2015-12-31
2018-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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HVPG group
HVPG-guided therapy
HVPG-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.
Carvedilol
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.
non-HVPG group
routine therapy
routine therapy
Patients start treatment without HVPG measurement and receive endoscopic therapy plus Carvedilol.
Carvedilol
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.
Interventions
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HVPG-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.
routine therapy
Patients start treatment without HVPG measurement and receive endoscopic therapy plus Carvedilol.
Carvedilol
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
70 Years
ALL
No
Sponsors
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Shanghai Public Health Clinical Center
OTHER_GOV
ShuGuang Hospital
OTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Shanghai Pudong New Area Gongli Hospital
OTHER
Eastern Hepatobiliary Surgery Hospital
OTHER
Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Shiyao Chen
Director of department of Gastroenterology, Zhongshan Hospital
Principal Investigators
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Shiyao Chen, Professor
Role: PRINCIPAL_INVESTIGATOR
Shanghai Zhongshan Hospital
Locations
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Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Yichao Wei, Doctor
Role: primary
Other Identifiers
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CSY-WYC02-2015
Identifier Type: -
Identifier Source: org_study_id