Clinical trial NCT02638415: The Effect of Hepatic Vein Pressure Gradient(HVPG)-Guided Therapy in Cirrhotic Patients With Esophagogastric Varices
Official title: The Effect of HVPG-Guided Individualized Therapy in Patients With Cirrhosis Related Esophagogastric Variceal Hemorrhage For Secondary Prophylaxis:A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gastroesophageal Varices
Cirrhosis
Keywords: HVPG
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Shanghai Public Health Clinical Center
name: ShuGuang Hospital
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Shanghai Pudong New Area Gongli Hospital
name: Eastern Hepatobiliary Surgery Hospital
First posted: 2015-12-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mortality rate
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Rebleeding rate
timeFrame: through study completion, an average of 1 year
measure: Adverse Events
timeFrame: through study completion, an average of 1 year
measure: Total cost
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Shiyao Chen, Professor
role: PRINCIPAL_INVESTIGATOR
References: