Interventional Devascularization Plus HVPG-Guided Carvedilol Therapy vs TIPS
1 other identifier
interventional
212
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2020
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2019
CompletedFirst Posted
Study publicly available on registry
December 13, 2019
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedFebruary 5, 2020
February 1, 2020
2.6 years
December 9, 2019
February 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cumulative incidence of gastric variceal rebleeding
Confirmed by endoscopy
12 months
Secondary Outcomes (5)
Cumulative incidence of variceal hemorrhage related death
12 months
Cumulative incidence of hepatic encephalopathy (HE)
12 months
Cumulative incidence of death
12 months
Cumulative incidence of adverse events
12 months
Correlation between hepatic venous pressure gradient response and cardiac index response to Carvedilol
12 months
Study Arms (2)
interventional devascularization
ACTIVE COMPARATORInterventional 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.
Transjugular intrahepatic portosystemic shunt
EXPERIMENTALTIPS is an artificial channel within the liver that establishes communication between the inflow portal vein and the outflow hepatic vein.
Interventions
Interventional devascularization (BRTO and its variations) is a procedure for treatment of fundal varices associated with a large gastro-/splenorenal collateral.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jun Tie, M.D.,Ph.D.
Air Force Military Medical University, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of clinical research
Study Record Dates
First Submitted
December 9, 2019
First Posted
December 13, 2019
Study Start
June 1, 2020
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
February 5, 2020
Record last verified: 2020-02