Clinical Trials Logo

Clinical Trial Summary

Upper gastrointestinal (UGI) bleed of variceal origin is a common medical emergency. Prompt endoscopic variceal ligation (EVL) is therapeutic as well as diagnostic. Terlipressin, a vasopressin analog (intravenous, 2 mg q 4 hourly), is widely used promptly in any suspicious cases of variceal haemorrhage (VH) before endoscopic intervention, along with volume and blood resuscitative measures. As per guideline, after EVL Terlipressin therapy (1 mg IV q 4 hourly) is advised to continue for 2-5 day to prevent re-bleed and mortality [1]. But the prolong use of Terlipressin is not completely safe as well as it is expensive also in resource constraint setting. At present, no randomized control clinical trial (RCT) is available to prove the efficacy of post-EVL Terlipressin therapy in preventing re-bleed and mortality in acute variceal haemorrhage. During the post marketing surveillance Terlipressin therapy was found to be associated with life threatening complication like cardiac arrhythmia, myocardial ischemia, critical vasoconstriction of peripheral as well as internal organ leading to ischemia or gangrene, severe hyponatremia, hypertension, fluid overload and pulmonary oedema (2-4). So the justification of continuing Terlipressin for 5 days after EVL is questionable, as the haemostasis is primarily achieved by EVL and the risk versus benefit of Trelipressin therapy after EVL is still unknown. Continue IV Terlipressin therapy also prolongs in-hospital care causing further increase of health care burden. As per recently concluded institutional study, continuing Terlipressin after EVL in acute VH did not prevent re-bleed or mortality, rather it increased the risk of ADR, duration of hospital stay, in-hospital complications and cost of the therapy [5]. But the study was open level with relatively smaller sample size. There is still lack of RCT on post-EVL Terlipressin therapy, regarding its efficacy in preventing re-bleed and mortality. So, we have planned this study to evaluate the efficacy of continuous Terlipressin therapy after EVL, in acute VH. It will be a double blind randomized controlled clinical trial. The study will be carried out in the 2 arms; denoting the duration of Terlipressin therapy after EVL. Participant with acute VH will be randomized into two study groups after successful EVL. The treatment group will receive injection Terlipressin (1 mg IV bolus q 4 hourly) for 2 days and the control group will receive 10 ml of 0.9% normal saline (NS) IV bolus q 4 hourly instead of Terlipressin for 2 days. Both the group will receive standard care of therapy and will be followed up for 8 weeks. The participants and the recruiter/PI will be unaware of intervention (terlipressin or NS) receiving. The study will enlighten us regarding efficacy of continuous Terlipressin therapy after EVL to prevent re- bleed and mortality in acute VH. The study will also generate significant data regarding adverse drug events (ADE) and cost effectiveness or pharmaco- economics of continue Terlipressin therapy after EVL. In the Indian population there is no study to determine the role gene related to variceal bleed or re-bleed. Endothelial dysfunction is the major contributor for the development of portal hypertension and subsequent varices formation in patient with cirrhosis. Development of blood vessel and endothelial function, endothelial proliferation and neoangiogenesis are regulated by vascular endothelial growth factor (VEGF) family genes. In a recently published study, VEGF C(+405)G(rs2010963) single nucleotide polymorphism (SNP) genotype was found to be associated with higher risk of esophageal and gastric varices and bleeding [10]. Since VEGF is the major factor to endothelial proliferation and neoangiogenesis. So, in this study, as a secondary objective, we will also try to explore the association of VEGF genotype with variceal bleed/ re-bleed and mortality.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06027970
Study type Interventional
Source Postgraduate Institute of Medical Education and Research
Contact Deba P Dhibar, MD
Phone 9530881462
Email drdeba_prasad@yahoo.co.in
Status Not yet recruiting
Phase Phase 3
Start date September 2023
Completion date December 2024

See also
  Status Clinical Trial Phase
Recruiting NCT04546360 - Spleen Stiffness Combined With Liver Stiffness Measured by 2D-SWE for the Screening of High-risk Varices in Compensated Advanced Chronic Liver Disease (CHESS2004)
Withdrawn NCT03891849 - Macro and Microcirculatory Effects of the Combination of Norepinephrine and Octreotide for the Treatment of Cirrhotic Patients With Hemorrhagic Shock N/A
Completed NCT03061604 - RCT to Determine the Efficacy of Combining Hemospray With Medical Treatment in Acute Variceal Bleeding N/A
Recruiting NCT05124041 - Goal-Directed Hemostatic Resuscitation Trial in ACLF Induced Coagulopathy N/A
Recruiting NCT04111120 - Heparin Like Effect in Acute Variceal Bleeding
Completed NCT03459378 - Outcome After TIPS
Not yet recruiting NCT06325436 - Objective Scores in Variceal Bleeding
Completed NCT03846180 - Terlipressin on Effect of Renal Function in Cirrhotic Patients With Acute Gastrointestinal Hemorrhage
Not yet recruiting NCT04254822 - HVPG-Guided Therapy vs Carvedilol Plus Endotherapy for the Prevention of Esophageal Variceal Rebleeding in Cirrhotic Patients N/A
Not yet recruiting NCT04207398 - TIPS vs. NSBB Plus Endotherapy for the Prevention of Variceal Rebleeding in NSBB Non-responders of Primary Prophylaxis N/A
Recruiting NCT05872698 - Beta-blockers or Placebo for Primary Prophylaxis (BOPPP) of Oesophageal Varices Trial. Phase 4
Not yet recruiting NCT03130127 - Continuous Versus Bolus Infusion of Terlipressin for Portal Hypertension Related Bleeding in Liver Cirrhosis N/A
Recruiting NCT03720067 - Propranolol, Carvedilol and Rosuvastatin in the Prevention of Variceal Bleeding in Cirrhotic Portal Hypertension Phase 2/Phase 3
Completed NCT01783899 - Clinical Evaluation of Hemospray in Hemostasis of Active Variceal Bleeding N/A
Completed NCT00825877 - Long-term Follow-up of HALT-C Sustained Virological Responders
Completed NCT05227833 - Vonoprazan Efficacy to Prevent Post Variceal Band Ligation Ulcer Phase 3
Recruiting NCT03267615 - VICIS - Vienna Cirrhosis Study
Recruiting NCT04640350 - Risk Prediction of Bleeding in Liver Cirrhosis by Combi-elastography
Not yet recruiting NCT01371591 - Capsule Endoscopy for Hemorrhage in the Emergency Room N/A