View clinical trials related to Variceal Hemorrhage.
Filter by:To assess the prognostic performance of the ALBI associated scores (ALBI, PALBI and INR-ALBI score) and new MELD .3 in predicting the short-term outcomes (early re-bleeding and early mortality) of patients with cirrhosis presenting with acute variceal bleeding, comparable to the CTP and MELD and MELD Na scores.
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.
Variceal bleeding is a major complication of cirrhosis, associated with a hospital mortality rate of 10%-20%. Surviving patients are at high risk for recurrent hemorrhage. For these reasons, management should be directed at its prevention. Endoscopic variceal band ligation (EBL) in combination with non-selective β-blocker (NSBB) therapy is the recommended first line therapy. Transjugular intrahepatic portosystemic stent-shunt (TIPS) is the most effective method to prevent rebleeding, however, it is burdened with increased hepatic encephalopathy and deterioration of liver function in patients with advanced cirrhosis. So TIPS placement forms an alternative if first line therapy fails. Hepatic venous pressure gradient (HVPG) is currently the best available method to evaluate the presence and severity of portal hypertension. Patients who experience a reduction in HVPG of ≥20% or to <12mmHg in response to drug therapy are defined as 'responders'. The lowest rebleeding rates are observed in patients on secondary prophylaxis who are HVPG responders. A recent meta-analysis has demonstrated that combination therapy is only marginally more effective than drug therapy. This suggests that pharmacological therapy is the cornerstone of combination therapy. Adding EBL may not be the optimal approach to improve the outcome of HVPG nonresponders and HVPG non-responders are a special high-risk population that may benefit from a more aggressive approach, such as an early decision for TIPS. It recently was shown that TIPS placement within 72 hours after acute bleeding not only prevented recurrent bleeding but also improved survival. These raise the question of whether ligation together with NSBB should remain the first choice for elective secondary prophylaxis. Therefore, the purpose of the study is to compare whether HVPG-guided therapy is superior to standard combination therapy for the prevention of variceal bleeding in patients with decompensated cirrhosis.
Variceal bleeding (VB) is a life-threatening complication of cirrhosis with a 6-week mortality of approximately 15%-20%. The 1-year rate of recurrent VB is approximately 60% in patients without prophylaxis treatment. Therefore, all patients who survive VB must receive active treatments to prevent rebleeding. Usually, these patients are submitted to rebleeding prophylaxis with endoscopic band ligation (EBL) combined with non-selective beta-blockers (NSBB). Transjugular intrahepatic portosystemic shunts (TIPS) are reserved for those who failed endoscopic plus medical treatment. A recent meta-analysis comparing combination therapy to monotherapy with EBL or drug therapy has demonstrated that combination therapy is only marginally more effective than NSBB alone. This suggests that NSBB is the cornerstone of combination therapy. The lowest rebleeding rates are observed in patients on secondary prophylaxis who are hepatic venous pressure gradient (HVPG) responders (defined as a reduction in HVPG below 12 mm Hg or > 20% from baseline). A recent study demonstrated that patients who have their first episode of variceal bleeding while on primary prophylaxis with NSBB have an increased risk of further bleeding and death, despite adding EBL. These patients possibly require alternative treatment approaches, such as TIPS. The aim of the present study was to compare the effect of TIPS vs. EBL + NSBB for the prevention of rebleeding in NSBB non-responder for primary prophylaxis.
Terlipressin is the mainstay drug for the treatment of acute variceal bleeding in liver cirrhosis. According to the drug instructions, intravenous bolus infusion is the standard approach of terlipressin. It remains unclear about whether or not continuous infusion of terlipressin should be considered.
The researcher's primary hypothesis is that VCE allows for safe outpatient management of ED patients with suspected upper GI hemorrhage. A prospective multicenter randomized control trial was designed to investigate the safety of this approach.