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

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ClinicalTrials.gov Identifier: NCT02638415
Recruitment Status : Unknown
Verified December 2015 by Shiyao Chen, Shanghai Zhongshan Hospital.
Recruitment status was:  Recruiting
First Posted : December 23, 2015
Last Update Posted : December 23, 2015
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Shiyao Chen, Shanghai Zhongshan Hospital

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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Varices Cirrhosis Procedure: HVPG-guided therapy Other: routine therapy Drug: Carvedilol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : December 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Carvedilol

Arm Intervention/treatment
Experimental: HVPG group
HVPG-guided therapy
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.


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.

non-HVPG group
routine therapy
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.




Primary Outcome Measures :
  1. Mortality rate [ Time Frame: through study completion, an average of 1 year ]
    The investigators observe the mortality events in both groups during the study


Secondary Outcome Measures :
  1. Rebleeding rate [ Time Frame: through study completion, an average of 1 year ]
    The investigators observe the rebleeding events in both groups during the study

  2. Adverse Events [ Time Frame: 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

  3. Total cost [ Time Frame: through study completion, an average of 1 year ]
    The investigators calculate the total cost of treatment of each patient during the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638415


Contacts
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Contact: Shiyao Chen, Professor 86-13601767310 chen.shiyao@zs-hospital.sh.cn

Locations
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China, Shanghai
Shanghai Zhongshan Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Yichao Wei, Doctor    86-13918891342    08301010253@fudan.edu.cn   
Principal Investigator: Shiyao Chen, Professor         
Sponsors and Collaborators
Shanghai Zhongshan Hospital
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
Investigators
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Principal Investigator: Shiyao Chen, Professor Shanghai Zhongshan Hospital

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Responsible Party: Shiyao Chen, Director of department of Gastroenterology, Zhongshan Hospital, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT02638415     History of Changes
Other Study ID Numbers: CSY-WYC02-2015
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: December 23, 2015
Last Verified: December 2015
Keywords provided by Shiyao Chen, Shanghai Zhongshan Hospital:
HVPG
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Antioxidants
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists