A Randomized Controlled Trial to Assess the Role of Emergent vs Early Endoscopy in Child B and C … (NCT06785701) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Randomized Controlled Trial to Assess the Role of Emergent vs Early Endoscopy in Child B and C Cirrhotic Patients With Acute Variceal Bleed (AVB)-EARLY - AVB
India220 participantsStarted 2025-01-20
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Child B and C cirrhotic patients with history of AVB
. \>18YRS and \<75 yrs.
. Fluid responsive within 1 hour after resuscitation
Exclusion criteria
. EHPVO / NCPH
. Lack of consent Pregnancy
. Child A cirrhotics
. Severe cardiopulmonary disease requiring optimization (Deemed contraindication for endoscopy within 12 hours).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing emergent endoscopy versus early endoscopy for acute variceal bleeding in Child B and C cirrhosis patients — can you explain what that timing difference actually means for my care, and which approach you would currently recommend for me based on my situation?
2Since this trial is not yet recruiting, how much longer might it be before it opens, and is waiting to potentially participate realistic given how urgent variceal bleeding can be?
3The trial is specifically enrolling Child B and C cirrhosis patients, which suggests more advanced liver disease — can you tell me where I fall on that classification and how that affects both my risk and my treatment options right now?
4The main thing this trial is measuring is whether patients survive to six weeks — does that tell us that the right timing of endoscopy is still genuinely uncertain, and what does current evidence say about which approach is safer in the meantime?
5If this trial isn't open yet or I'm not a good candidate, what is the standard of care approach for timing endoscopy in my case, and are there other studies already underway that might be worth considering?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of mortality within 6 weeks in Child B&C
Timeframe: 6 weeks
Trial details
NCT IDNCT06785701
SponsorInstitute of Liver and Biliary Sciences, India