Acute Variceal Bleed
Conditions
Brief summary
Summary-Variceal bleeding - 70% of all upper gastro-intestinal bleeding episodes in patients with portal hypertension, and they result from esophageal varices (EVs), gastric varices (GVs), or ectopic varices. Management of Acute variceal bleeding includes endoscopic variceal ligation (EVL) along with vasoactive agents. Inspite of successful hemostasis, this is associated with high variceal rebleeding (VRB) in Child B and C cirrhosis and have higher 6-week mortality rates and liver related adverse events. From time of presentation to emergent endoscopy that is 4 hours can reduce the mortality when compared early endoscopy within 4-12 hours so that mortality rate related to bleed can reduced and early hemostasis can be achieved.
Detailed description
1. Aim and Objectives -To assess the role of Emergent Endoscopy vs Early endoscopy in patients with Acute variceal bleed in CHILD B&C Cirrhosis. 2. Hypothesis - Early use of endoscopy along with adequate resuscitation and medical optimization in patients with Child B/C cirrhosis would lead to higher rates of endoscopic hemostasis thereby associated with better clinical outcomes, in terms of in hospital mortality rate and Liver failure related mortality in post bleed, recurrent bleeding rates. Study population- Patient presenting with AVB as per definition in Child B &C cirrhotics. Study design- Randomized Control Trial Non Inferior Trial. Study area- ILBS , Delhi Intervention: Patient after screening for all exclusion criteria will be randomized into either Emergent endoscopy or Early endoscopy Monitoring and assessment: All patients would undergo vital and baseline parameter screening before randomization. Based on randomization they will undergo the Endoscopy procedure.Post procedure patient will be followed and evaluated for rebleed, mortality, liver related events if any like Hepatic encephalopathy, Ascites, Ischemic hepatitis.
Interventions
PROCEDUREUpper Gastrointestinal Endoscopy
After Entering to emergency based on time of hemetemsis and based on presentation to ER , patient will be assessed and based on hemodyamic stability patient can be taken Early/Emergent endoscopy.
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Child B and C cirrhotic patients with history of AVB 2. \>18YRS and \<75 yrs. 3. Fluid responsive within 1 hour after resuscitation
Exclusion criteria
1. EHPVO / NCPH 2. Lack of consent Pregnancy 3. Child A cirrhotics 4. Severe cardiopulmonary disease requiring optimization (Deemed contraindication for endoscopy within 12 hours). 5. Need of Dual vasopressors at presentation In Hospital patients with Bleed 6. HCC patients with AVB 7. Patients presented with AVB on going antiplatelets/anticoagulants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of mortality within 6 weeks in Child B&C | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients rebleed at D5 | Day 5 |
| Proportion of patients required repeated hospital admissions and number days pf hospitalisation | 6 weeks |
| Proportion of LRE post bleed within 6 weeks - Ascites/ Hepatic Encephalopathy | 6 weeks |
| Proportion of rebleed within 6 weeks in Chid B &C | 6 weeks |
| Patients need of TIPS/BRTO/EUS in AVB | 6 weeks |
| Percentage of endoscopic hemostasis is achieved at 24 hours | 24 hours |
| Percentage requiring ICU saty and duration of saty post AVB | 6 weeks |
| Proportion of patients developing Ischemic hepatitis | 6 weeks |
Countries
India
Contacts
Primary ContactDr Sanda Kavitha, MD
Backup ContactDr Harsh Vardhan Tevethia, DM
Outcome results
None listed