Thalidomide Versus Argon Plasma Coagulation in Gastric Antral Vascular Ectasia(GAVE)-Related Anaemia in Cirrhosis (TAG Trial)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Thalidomide, Argon Plasma Coagulation.
- Who it may be relevant to
- Registry conditions: Liver Cirrhosis, Gastric Antral Vascular Ectasia. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Thalidomide Versus Argon Plasma Coagulation in Gastric Antral Vascular Ectasia(GAVE)-Related Anaemia in Cirrhosis (TAG Trial)- A Randomised Controlled Trial
Overview
Gastric Antral Vascular Ectasia (GAVE) is an erosive form of gastritis distinguished by veno-capillary ectasia, which manifests as tortuous columns of dilated vessels. Histologically, these vessels show dilated mucosal capillaries filled with fibrin thrombi, accompanied by fibromuscular hyperplasia and spindle cell proliferation of the lamina propria. GAVE is prevalent in about 12% of patients with cirrhosis, with 60-70% of these patients becoming transfusion-dependent due to severe anaemia caused by GAVE related bleeding. The most commonly used treatment for GAVE is endoscopic therapy using Argon Plasma Coagulation (APC), which, while effective, often requires multiple sessions due to a high recurrence rate of 30-60%. These frequent interventions increase the burden on patients and healthcare systems. As a result, alternative treatments have been sought. Thalidomide, known for its potent antiangiogenic properties, significantly lowers vascular endothelial growth factor (VEGF) levels, offering a promising non-invasive treatment option. Early studies, such as those by García-Pagán have demonstrated thalidomide's effectiveness in reducing transfusion requirements and managing bleeding in cirrhotic patients with GAVE, yet its comprehensive efficacy and safety profile remains under-studied. This project aims to rigorously evaluate the efficacy and safety of thalidomide compared to APC in managing GAVE-related anemia in cirrhotic patients. Through a controlled trial, this study will provide vital data to potentially shift treatment paradigms, enhance patient quality of life, and reduce the need for repetitive invasive procedures.
Detailed description
Aim: To evaluate and compare the efficacy and safety of thalidomide with argon plasma coagulation (APC) in managing gastric antral vascular ectasia (GAVE)-related anaemia in patients with cirrhosis.
Hypothesis: Thalidomide, due to its antiangiogenic effects, will more effectively reduce GAVE-related bleeding, improve haemoglobin levels, and decrease transfusion dependency compared to APC in patients with cirrhosis and GAVE-related anaemia.
Study Design:
Single-centre, open-label, randomised controlled trial to compare the efficacy and safety of thalidomide versus argon plasma coagulation (APC) in managing GAVE-related anaemia in cirrhotic patients.
Study Population:
Adult patients (aged 18-65 years) diagnosed with cirrhosis and endoscopically confirmed GAVE-related anaemia, presenting at the Institute of Liver and Biliary Sciences.
Randomization: Patients will be randomly assigned to receive either thalidomide or APC in a 1:1 ratio by block randomization method with block size of 10 and it will be implemented by using ILBS IWRS facility.
Follow-up and Assessments:
* Patients will be followed every two weeks for the first month, then monthly up to six months. Assessments will include haemoglobin levels, the number of transfused blood units, the frequency of bleeding episodes, hospitalizations, and the number of required endoscopic sessions. * Adverse effects will be monitored and recorded at each visit.
Interventions
- Drug Thalidomide
Patients will receive oral thalidomide starting at 50 mg daily, with a weekly increase of 50 mg up to a maximum of 200 mg daily, continued for four months - Procedure Argon Plasma Coagulation
Patients will undergo APC treatment every 2-3 weeks initially, followed by maintenance sessions every three months as required.
Primary outcome measures
- Mean increase in hemoglobin levels from baseline [Time frame: 4 months]
Secondary outcome measures (12)
- Atleast 50 percent change in requirement of PRBCs transfusions at the end of 4 months [Time frame: 4 months]
- Increase in serum iron levels, percent transferrin saturation at the end of 4months [Time frame: 4 months]
- Change in amount of PRBC's transfused at the end of 4 months. [Time frame: 4 months]
- Change in GAVE related bleeding episodes at the end of 4 months [Time frame: 4 months]
- Number of hospitalizations due to GAVE related anemia, in 4 months [Time frame: 4 months]
- Duration of days of hospitalization due to GAVE related anemia in 4 months [Time frame: 4 months]
- Need of rescue endoscopic sessions in 4 months in thalidomide group [Time frame: 4 months]
- Endoscopic resolution of GAVE at the end of 4 months [Time frame: 4 months]
- Change in VEGF levels in Thalidomide group at the end of 4 months [Time frame: 4 months]
- Change in pepsinogen levels in Thalidomide group at the end of 4 months [Time frame: 4 months]
- Change in gastrin levels in Thalidomide group at the end of 4 months [Time frame: 4 months]
- Adverse events in each group at the end of 4 months [Time frame: 4 months]
Eligibility criteria
Inclusion criteria
- Adult patients (aged ≥18 - 65years)
- Cirrhosis
- Endoscopically confirmed diagnosis of GAVE
- +/- GAVE with active ooze
- Iron deficiency anemia\*
- Ability to provide informed consent
Exclusion criteria
- CTP >/=13
- Active GI Bleeding is caused by a cause other than GAVE.
- Renal insufficiency ( Creatinine >3mg/dL and/or on RRT)
- Pregnancy or childbearing age
- Contraindications to thalidomide therapy: Severe peripheral neuropathy or seizures or a history of thromboembolic disease.
- Use of antiangiogenic drugs
- Bevacizumab, steroids, octreotide
- Severe cardiopulmonary disorders
- H/o thalidomide use in the past 3months
- Contraindications to APC: Coagulopathy( Pacemaker or implantable defibrillator, Platelet <45000, INR: >1.8 )
- Overt Hepatic Encephalopathy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
India · 1 center
- Institute of Liver & Biliary Sciences (ILBS) — New Delhi
Identifiers
NCT: NCT06772480 · ILBS-Cirrhosis-70