Acute Variceal BleedNCT06785701
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
A study testing Upper Gastrointestinal Endoscopy in people with Acute Variceal Bleed, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Variceal Bleed
- What is being tested?
- Upper Gastrointestinal Endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteIndia
- Study dates
- 20 Jan 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Child B and C cirrhotic patients with history of AVB
- >18YRS and <75 yrs.
- Fluid responsive within 1 hour after resuscitation
Who cannot join
- EHPVO / NCPH
- Lack of consent Pregnancy
- Child A cirrhotics
- Severe cardiopulmonary disease requiring optimization (Deemed contraindication for endoscopy within 12 hours).
- Need of Dual vasopressors at presentation In Hospital patients with Bleed
- HCC patients with AVB
- Patients presented with AVB on going antiplatelets/anticoagulants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, 110070
Dr Sanda Kavitha, MD, 01146300000, sandakavitha1001@gmail.com
About this study
Official title: 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.
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.
Read the detailed description
- Aim and Objectives -To assess the role of Emergent Endoscopy vs Early endoscopy in patients with Acute variceal bleed in CHILD B\&C Cirrhosis.
- 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.
- Conditions
- Acute Variceal Bleed
- Being tested
- Upper Gastrointestinal Endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper Gastrointestinal EndoscopyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Emergent Endoscopy | Experimental | UGIE T1-T4 hrs Receives: Procedure: Upper Gastrointestinal Endoscopy |
| Early endoscopy | Active comparator | UGIE T4-T12 hrs Receives: Procedure: Upper Gastrointestinal Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of mortality within 6 weeks in Child B&C
Measured: 6 weeks
Secondary outcomes (8)
Proportion of rebleed within 6 weeks in Chid B &C
Measured: 6 weeks
Proportion of patients rebleed at D5
Measured: Day 5
Proportion of patients required repeated hospital admissions and number days pf hospitalisation
Measured: 6 weeks
Proportion of LRE post bleed within 6 weeks - Ascites/ Hepatic Encephalopathy
Measured: 6 weeks
Proportion of patients developing Ischemic hepatitis
Measured: 6 weeks
Patients need of TIPS/BRTO/EUS in AVB
Measured: 6 weeks
Percentage of endoscopic hemostasis is achieved at 24 hours
Measured: 24 hours
Percentage requiring ICU saty and duration of saty post AVB
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start20 Jan 2025 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Variceal BleedStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785701
- Sponsor's protocol ID
- ILBS-AVB-01
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 21 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06785701
- Acronym / sponsor ID
- ILBS-AVB-01
- Conditions
- Acute Variceal Bleed
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 20 Jan 2025 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 21 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Aim and Objectives -To assess the role of Emergent Endoscopy vs Early endoscopy in patients with Acute variceal bleed in CHILD B\&C Cirrhosis.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emergent Endoscopy | Experimental | Procedure: Upper Gastrointestinal EndoscopyUGIE T1-T4 hrs |
| Early endoscopy | Active comparator | Procedure: Upper Gastrointestinal EndoscopyUGIE T4-T12 hrs |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Child B and C cirrhotic patients with history of AVB
- >18YRS and <75 yrs.
- Fluid responsive within 1 hour after resuscitation
Key exclusion criteria (7 listed)
- EHPVO / NCPH
- Lack of consent Pregnancy
- Child A cirrhotics
- Severe cardiopulmonary disease requiring optimization (Deemed contraindication for endoscopy within 12 hours).
- Need of Dual vasopressors at presentation In Hospital patients with Bleed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper Gastrointestinal EndoscopyAfter 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. | Procedure or surgery | Early endoscopy, Emergent Endoscopy |
Primary outcome
Proportion of mortality within 6 weeks in Child B&C
Time frame: 6 weeks
8 secondary outcomes
Proportion of rebleed within 6 weeks in Chid B &C
Time frame: 6 weeks
Proportion of patients rebleed at D5
Time frame: Day 5
Proportion of patients required repeated hospital admissions and number days pf hospitalisation
Time frame: 6 weeks
Proportion of LRE post bleed within 6 weeks - Ascites/ Hepatic Encephalopathy
Time frame: 6 weeks
Proportion of patients developing Ischemic hepatitis
Time frame: 6 weeks
Patients need of TIPS/BRTO/EUS in AVB
Time frame: 6 weeks
Percentage of endoscopic hemostasis is achieved at 24 hours
Time frame: 24 hours
Percentage requiring ICU saty and duration of saty post AVB
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Variceal Bleed
Active, not recruiting
Timing of Endoscopy in Cirrhotic Patients With Acute Variceal Bleeding
Acute Upper Gastrointestinal Bleeding, Acute Variceal Bleeding
Not yet recruiting
Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Variceal Bleeding and Renal Dysfunction
Liver Cirrhosis
Not yet recruiting
Keverprazan vs Pantoprazole for the Treatment of ANVUGIB
Non-variceal Upper Gastrointestinal Bleeding
RecruitingPhase 2
PPIs and In-Hospital Morbidity in Acute Variceal Bleeding With Chronic Liver Disease
Morbidity
Not yet recruitingObservational study
Acute Kidney Injury in Upper GI Bleeding Patients
Upper Gastrointestinal Bleeding, Acute Kidney Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper Gastrointestinal Endoscopy in people with Acute Variceal Bleed, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Sanda Kavitha, MD (01146300000, sandakavitha1001@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of mortality within 6 weeks in Child B&C (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2025.