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NCT Number: NCT06772480

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

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.

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Key information

Conditions

Liver Cirrhosis Angiodysplasia Cardiovascular Diseases Digestive System Diseases Fibrosis Gastric Antral Vascular Ectasia Gastrointestinal Diseases Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stomach Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver & Biliary Sciences (ILBS)

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

Location contact

Dr Aakula Suguna Sree, MD

CONTACT

[email protected]

01146300000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Argon Plasma Coagulation

Procedure

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

Primary outcomes

  1. Mean increase in hemoglobin levels from baseline

    Time frame: 4 months

Secondary outcomes

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

    Time frame: 4 months

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

    Time frame: 4 months

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

    Time frame: 4 months

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

    Time frame: 4 months

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

    Time frame: 4 months

  6. Duration of days of hospitalization due to GAVE related anemia in 4 months

    Time frame: 4 months

  7. Need of rescue endoscopic sessions in 4 months in thalidomide group

    Time frame: 4 months

  8. Endoscopic resolution of GAVE at the end of 4 months

    Time frame: 4 months

    Endoscopic resolution is defined as endoscopic findings of GAVE as absent.

  9. Change in VEGF levels in Thalidomide group at the end of 4 months

    Time frame: 4 months

  10. Change in pepsinogen levels in Thalidomide group at the end of 4 months

    Time frame: 4 months

  11. Change in gastrin levels in Thalidomide group at the end of 4 months

    Time frame: 4 months

  12. Adverse events in each group at the end of 4 months

    Time frame: 4 months

  13. Quality of life measures - Short Form 36

    Time frame: 4 months

    Quality of life measures - Short Form 36 ranges from 0 to 100, 0 indicate maximum disability and 100 indicate no disability.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Aakula Suguna Sree, MD

CONTACT

[email protected]

01146300000

Dr Babu Lal Meena, DM

CONTACT

[email protected]

01146300000

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2025
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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