Thalidomide Versus Argon Plasma Coagulation in Gastric Antral Vascular Ectasia(GAVE)-Related Anaemia in Cirrhosis (TAG Trial)

NCT06772480 | Not Yet Recruiting

• 1 other identifier: ILBS-Cirrhosis-70
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Cirrhosis; Gastric Antral Vascular Ectasia

Outcome Measures

Primary Outcomes (1)

• Mean increase in hemoglobin levels from baseline

  4 months

Secondary Outcomes (13)

• Atleast 50 percent change in requirement of PRBCs transfusions at the end of 4 months

  4 months

• Increase in serum iron levels, percent transferrin saturation at the end of 4months

  4 months

• Change in amount of PRBC's transfused at the end of 4 months.

  4 months

• Change in GAVE related bleeding episodes at the end of 4 months

  4 months

• Number of hospitalizations due to GAVE related anemia, in 4 months

  4 months

Study Arms (2)

Thalidomide Group

EXPERIMENTAL

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.

Drug: Thalidomide

APC Group

ACTIVE COMPARATOR

Patients will undergo APC treatment every 2-3 weeks initially, followed by maintenance sessions every three months as required.

Procedure: Argon Plasma Coagulation

Interventions

Thalidomide DRUG

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

Thalidomide Group

Argon Plasma Coagulation PROCEDURE

Patients will undergo APC treatment every 2-3 weeks initially, followed by maintenance sessions every three months as required.

APC Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (aged ≥18 - 65years)
• Cirrhosis
• Endoscopically confirmed diagnosis of GAVE
• +/- GAVE with active ooze
• Iron deficiency anemia\*
• Ability to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Liver Cirrhosis; Gastric Antral Vascular Ectasia

Interventions

Thalidomide; Argon Plasma Coagulation

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stomach Diseases; Gastrointestinal Diseases; Angiodysplasia; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Electrocoagulation; Cautery; Therapeutics; Hemostatic Techniques; Ablation Techniques; Surgical Procedures, Operative; Hemostasis, Surgical

Central Study Contacts

Dr Aakula Suguna Sree, MD

CONTACT

01146300000; sugunasreeaakula@gmail.com

Dr Babu Lal Meena, DM

CONTACT

01146300000; drbabupgi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2025
• First Posted: January 13, 2025
• Study Start: January 5, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: January 13, 2025

Record last verified: 2024-12

Locations

IN (1)