- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04198259
Interventional Devascularization Plus HVPG-Guided Carvedilol Therapy vs TIPS
Interventional Devascularization Plus HVPG-Guided Carvedilol Therapy vs TIPS for the Prevention of Gastric Variceal Rebleeding in Patients With Liver Cirrhosis: A Prospective, Randomized, Controlled Trial
Gastric varices (GV) are present in around 20% of patients with cirrhosis. Bleeding from GV accounts for 10-20% of all variceal bleeding. For the prevention of gastric variceal bleeding, TIPS or BRTO as firstline treatments were suggested.
No randomized trials have compared BRTO with other therapies. BRTO and its variations might increase portal pressure and might worsen complications, such as ascites or bleeding from EV. In this regard, if NSBB is combined with BRTO and its variations (we called interventional devascularization) for those HVPG responders, the drawbacks of interventional devascularization might be overcome. Therefore, the investigators conducted this RCT to compare the effectiveness and safety of TIPS with those of interventional devascularization in the prevention of rebleeding from gastric varices.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Gastric varices (GV) are present in around 20% of patients with cirrhosis. Bleeding from GV accounts for 10-20% of all variceal bleeding. GV are classified according to their location in the stomach and their relationship with esophageal varices (EV). Accordingly, GV are divided into gastroesophageal varices (GOV) and isolated gastric varices (IGV) . The management of type 1 GOV, which extend from the esophagus along the lesser curvature of the stomach, is similar to the management of EV. Historically, bleeding from type 2 GOV (i.e. GOV extending into the fundus), type 1 IGV (i.e. located in the fundus) and type 2 IGV (i.e. located anywhere in the stomach), is considered to be more severe and difficult to treat than EV bleeding. Few studies, mostly retrospective and uncontrolled, have focused on the management of non-GOV1 GV, and the optimal treatment remains controversial.
For the prevention of gastric variceal bleeding, treatment principles can be classified into two categories: decreasing portal pressure and obstructing GEV. Methods for decreasing portal pressure include medications (NSBB), radiological intervention (TIPS) and surgery. In contrast, methods for treating the obstruction of GEV include endoscopic approaches (EVL, EIS) or radiological intervention (such as BRTO). Recent portal hypertensive bleeding suggested TIPS or BRTO as firstline treatments in the prevention of rebleeding.
BRTO is a procedure for treatment of fundal varices associated with a large gastro-/splenorenal collateral. The technique involves retrograde cannulation of the left renal vein by the jugular or femoral vein, followed by balloon occlusion and slow infusion of sclerosant to obliterate the gastro-/splenorenal collateral and fundal varices. Several variations of the technique exist, such as balloon-occluded antegrade transvenous obliteration or occlusion of the collateral by the placement of a vascular plug or coils. BRTO has the theoretical advantage over TIPS that it does not divert portal blood inflow from the liver. On the other hand, BRTO and its variations might increase portal pressure and might worsen complications, such as ascites or bleeding from EV. In this regard, if NSBB is combined with BRTO and its variations (we called interventional devascularization) for those HVPG responders, the drawbacks of interventional devascularization might be overcome.
Therefore, the investigators conducted this RCT to compare the effectiveness and safety of TIPS with those of interventional devascularization in the prevention of rebleeding from gastric varices.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jun Tie, M.D.,Ph.D.
- Phone Number: +862984771537
- Email: tiejun7776@163.com
Study Contact Backup
- Name: Hui Chen, M.D.,Ph.D.
- Phone Number: +862984771537
- Email: qychenhui@163.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Liver cirrhosis diagnosed by clinical examination, imaging or biopsy
- Patients with a previous history of variceal hemorrhage
- Gastric variceal confirmed by an endoscopic examination, including IGV1 or IGV2
- Aged 18 to 75 years
- Adequate liver and kidney function, including Child-Turcotte-Pugh score < 12, MELD score <19, and serum creatinine less than 2 times the upper limit of normal.
Exclusion Criteria:
- Active variceal bleeding
- Esophageal variceal, including GOV1 or GOV2 type, mainly esophageal varices;
- Refractory ascites
- Patients with contraindication to treatment of TIPS, including congestive heart failure, NYHA III and IV, pulmonary arterial hypertension(>50mmHg), polycystic liver, intrahepatic duct dilatation, spontaneous bacterial peritonitis, hepatic encephalopathy
- Patients with contraindication to treatment of Carvedilol, including asthma, insulin-dependent diabetes, peripheral vascular diseases
- Child-Turcotte-Pugh score >=12, or MELD score >=19
- Budd-Chiari syndrome
- The main portal vein thrombosis is greater than 50%
- Malignancies
- An uncontrolled infection
- Previously treated with TIPS, splenectomy pericardia vascular disconnection, or surgical shunts
- HIV or HIV related illness
- Allergic to contrast agent
- Lactating or pregnant
- Non-compliant patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: interventional devascularization
Interventional devascularization includes BRTO and similar procedure.
Several variations of the technique exist, such as balloon-occluded antegrade transvenous obliteration or occlusion of the collateral by the placement of a vascular plug or coils.
|
Interventional devascularization (BRTO and its variations) is a procedure for treatment of fundal varices associated with a large gastro-/splenorenal collateral.
|
EXPERIMENTAL: Transjugular intrahepatic portosystemic shunt
TIPS is an artificial channel within the liver that establishes communication between the inflow portal vein and the outflow hepatic vein.
|
TIPS is very effective in the treatment of bleeding GV, with more than a 90% success rate for initial hemostasis.
It frequently requires additional embolization of spontaneous collaterals feeding the varices.
The incidence of encephalopathy was higher after TIPS.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative incidence of gastric variceal rebleeding
Time Frame: 12 months
|
Confirmed by endoscopy
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative incidence of variceal hemorrhage related death
Time Frame: 12 months
|
12 months
|
|
Cumulative incidence of hepatic encephalopathy (HE)
Time Frame: 12 months
|
HE is classified as covert HE and overt HE
|
12 months
|
Cumulative incidence of death
Time Frame: 12 months
|
all cause mortality
|
12 months
|
Cumulative incidence of adverse events
Time Frame: 12 months
|
number of adverse events and adverse reactions in each arm
|
12 months
|
Correlation between hepatic venous pressure gradient response and cardiac index response to Carvedilol
Time Frame: 12 months
|
Investigate non-invasive tools for risk stratification
|
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jun Tie, M.D.,Ph.D., Air Force Military Medical University, China
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY20192116-F-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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