The Effect of Hepatic Vein Pressure Gradient(HVPG)-Guided Therapy in Cirrhotic Patients With Esophagogastric Varices

Cirrhosis Clinical Trial

Official title:

The Effect of HVPG-Guided Individualized Therapy in Patients With Cirrhosis Related Esophagogastric Variceal Hemorrhage For Secondary Prophylaxis:A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02638415
• Other study ID #: CSY-WYC02-2015
• Status: Recruiting
• Phase: Phase 4
• First received: December 9, 2015
• Last updated: December 20, 2015
• Start date: December 2015
• Est. completion date: September 2018

Study information

• Verified date: December 2015
• Source: Shanghai Zhongshan Hospital
• Contact: Shiyao Chen, Professor
• Phone: 86-13601767310
• Email: chen.shiyao[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cirrhosis
• Esophageal and Gastric Varices
• Gastroesophageal Varices
• Liver Cirrhosis

Intervention

Procedure:
• 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.

Other:
• routine therapy
Patients start treatment without HVPG measurement and receive endoscopic therapy plus Carvedilol.

Drug:
• 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.

Locations

Country	Name	City	State
China	Shanghai Zhongshan Hospital	Shanghai	Shanghai

Sponsors (7)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Eastern Hepatobiliary Surgery Hospital, Gongli Hospital of Shanghai Pudong District, 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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate	The investigators observe the mortality events in both groups during the study	through study completion, an average of 1 year	No
Secondary	Rebleeding rate	The investigators observe the rebleeding events in both groups during the study	through study completion, an average of 1 year	No
Secondary	Adverse Events	The investigators observe any severe adverse events caused by HVPG measurement, endoscopic procedures,use of Carvedilol, surgical operations or TIPS	through study completion, an average of 1 year	Yes
Secondary	Total cost	The investigators calculate the total cost of treatment of each patient during the study	through study completion, an average of 1 year	No