Acute Bleeding Esophageal VaricesAVB-EVL+SNCT01267669
A Trial of Somatostatin With Endoscopic Variceal Ligation (EVL) in Control of Acute Variceal Bleeding
A study testing Somatostatin in people with Acute Bleeding Esophageal Varices and Portal Hypertension, run by Govind Ballabh Pant Hospital at 1 site in India.
Trial summary
Background: Efficacy of endoscopic variceal sclerotherapy in achieving initial control of acute variceal bleeding and five-day haemostasis has been shown to significantly improve when vasoactive drug is added. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Acute Bleeding Esophageal Varices, Portal Hypertension, Cirrhosis
- What is being tested?
- Somatostatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2005to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of portal hypertension
- Having hematemesis and/or melena within 24 hour prior to admission
- Source of bleeding should be esophageal varices
Who cannot join
- Non-cirrhotic cause of portal hypertension
- Age <12 or >75 years
- Hepatic encephalopathy grade 3 or 4
- Renal failure with serum creatinine >2 mg/dL
- Any evidence of bleeding from additional source apart from esophageal varices (like gastric varices, portal hypertensive gastropathy, erosions or ulcers including variceal ulcers)
- Patients already on vasoactive drugs like somatostatin or terlipressin during the current episode of bleeding
Show all 12Show fewer
- Patients already received EVL or EST elsewhere during the current episode of bleeding prior to presenting to our hospital
- Patients with history of surgery for portal hypertension or TIPS
- Concomitant severe cardio-pulmonary disease
- Concomitant malignancy
- HVPG not possible within 24 hrs of presentation
- Patients refusing to participate in the study.
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Gastroenterology, G B Pant Hospital
New Delhi, National Capital Territory of Delhi, 110 002
About this study
Official title: A Double Blind Randomized Placebo-Controlled Trial of Somatostatin in Association With Endoscopic Variceal Ligation (EVL) in Control of Acute Variceal Bleeding
Background: Efficacy of endoscopic variceal sclerotherapy in achieving initial control of acute variceal bleeding and five-day haemostasis has been shown to significantly improve when vasoactive drug is added. However, there is limited data whether addition of somatostatin, to endoscopic variceal ligation (EVL) improves the efficacy of EVL.
Aim: To compare EVL plus somatostatin versus EVL plus placebo in control of acute variceal bleeding.
Patients and methods: Consecutive cirrhotic patients with acute variceal bleeding from esophageal varices were enrolled in the trial. After emergency EVL, patients were randomized to receive either somatostatin (250 mcg/hr) or placebo infusion. Primary endpoint was treatment failure within 5 days. Treatment failure was defined as fresh hematemesis ≥2 hour after start of therapy or death.
- Being tested
- Somatostatin, Placebo
- Keywords
- Variceal bleeding, Endoscopic therapy, Band ligation, Somatostatin, Vasoactive drugs, Octreotide
- Medical subject headings
- Hypertension, Portal, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatostatinDrug
Also called Somatosan, Somastin
Emergency EVL plus Somatostatin (250 mcg/hr) infusion for 5 days
PlaceboDrug
Emergency EVL plus placebo infusion for 5 days
| Study group | Role | What they receive |
|---|---|---|
| EVL plus Somatostatin | Experimental | Emergency EVL plus Somatostatin (250 mcg/hr) infusion for 5 days Receives: Drug: Somatostatin |
| EVL plus Placebo | Placebo comparator | Emergency EVL plus placebo infusion for 5 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure
The primary endpoint was treatment failure, defined as the occurrence of any of the following within a period of 120 h (5 days) from the time of admission: (i) Fresh hematemesis ≥2 hr after EVL; or (ii) Death within 5 days.
Measured: 5 days
Secondary outcomes (4)
In-hospital mortality
Death during the same admission to the hospital
Measured: During the same admission
Transfusion requirement
Amount of packed cell or FFP infusions received during the hospital stay
Measured: During hospital stay
ICU stay in days
Number of dys the patient spent in ICU
Measured: During the hospital stay
Drug-related adverse effects
Adverse effects due to somatostatin or placebo infusion
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2010 (estimated)
- Study startNov 2005
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Bleeding Esophageal VaricesStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Govind Ballabh Pant Hospital
- Sponsor type
- Other government
- Investigators
- Shiv K Sarin, MD, DM, Principal investigator, G B Pant Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267669
- Sponsor's protocol ID
- 2005-PHT-01
- Acronym
- AVB-EVL+S
- Status last verified
- Dec 2010
- First submitted
- 27 Dec 2010
- Last updated
- 28 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Kumar A, Jha SK, Mittal VV, Sharma P, Sharma BC, Sarin SK. Addition of Somatostatin After Successful Endoscopic Variceal Ligation Does not Prevent Early Rebleeding in Comparison to Placebo: A Double Blind Randomized Controlled Trial. J Clin Exp Hepatol. 2015 Sep;5(3):204-12. doi: 10.1016/j.jceh.2015.06.001. Epub 2015 Jun 16.
PubMed 26628838
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Randomized Placebo-Controlled Trial of Somatostatin in Association With Endoscopic Variceal Ligation (EVL) in Control of Acute Variceal Bleeding
- ClinicalTrials.gov ID
- NCT01267669
- Acronym / sponsor ID
- AVB-EVL+S / 2005-PHT-01
- Keywords
- Variceal bleeding, Endoscopic therapy, Band ligation, Somatostatin, Vasoactive drugs, Octreotide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Govind Ballabh Pant HospitalOther government
- Study start
- Nov 2005
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 28 Dec 2010 (estimated)
- 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.
Background: Efficacy of endoscopic variceal sclerotherapy in achieving initial control of acute variceal bleeding and five-day haemostasis has been shown to significantly improve when vasoactive drug is added. However, there is limited data whether addition of somatostatin, to endoscopic variceal ligation (EVL) improves the efficacy of EVL.
Aim: To compare EVL plus somatostatin versus EVL plus placebo in control of acute variceal bleeding.
Patients and methods: Consecutive cirrhotic patients with acute variceal bleeding from esophageal varices were enrolled in the trial. After emergency EVL, patients were randomized to receive either somatostatin (250 mcg/hr) or placebo infusion. Primary endpoint was treatment failure within 5 days. Treatment failure was defined as fresh hematemesis ≥2 hour after start of therapy or death.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EVL plus Somatostatin | Experimental | Drug: SomatostatinEmergency EVL plus Somatostatin (250 mcg/hr) infusion for 5 days |
| EVL plus Placebo | Placebo comparator | Drug: PlaceboEmergency EVL plus placebo infusion for 5 days |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of portal hypertension
- Having hematemesis and/or melena within 24 hour prior to admission
- Source of bleeding should be esophageal varices
Key exclusion criteria (12 listed)
- Non-cirrhotic cause of portal hypertension
- Age <12 or >75 years
- Hepatic encephalopathy grade 3 or 4
- Renal failure with serum creatinine >2 mg/dL
- Any evidence of bleeding from additional source apart from esophageal varices (like gastric varices, portal hypertensive gastropathy, erosions or ulcers including variceal ulcers)
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 |
|---|---|---|
| SomatostatinAlso: Somatosan, SomastinEmergency EVL plus Somatostatin (250 mcg/hr) infusion for 5 days | Drug | EVL plus Somatostatin |
| PlaceboEmergency EVL plus placebo infusion for 5 days | Drug | EVL plus Placebo |
Primary outcome
Treatment failure
Time frame: 5 days
The primary endpoint was treatment failure, defined as the occurrence of any of the following within a period of 120 h (5 days) from the time of admission: (i) Fresh hematemesis ≥2 hr after EVL; or (ii) Death within 5 days.
4 secondary outcomes
In-hospital mortality
Time frame: During the same admission
Transfusion requirement
Time frame: During hospital stay
ICU stay in days
Time frame: During the hospital stay
Drug-related adverse effects
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2010.
- Derived from this study: PubMed 26628838Kumar A, Jha SK, Mittal VV, Sharma P, Sharma BC, Sarin SK. Addition of Somatostatin After Successful Endoscopic Variceal Ligation Does not Prevent Early Rebleeding in Comparison to Placebo: A Double Blind Randomized Controlled Trial. J Clin Exp Hepatol. 2015 Sep;5(3):204-12. doi: 10.1016/j.jceh.2015.06.001. Epub 2015 Jun 16.
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. This study is not recruiting at the moment.
Shiv K Sarin, MD, DM principal investigator
G B Pant Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Somatostatin in people with Acute Bleeding Esophageal Varices and Portal Hypertension, run by Govind Ballabh Pant Hospital 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 12 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: finished, as of the sponsor's last update on 28 Dec 2010. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01267669, which also lists 1 linked publication.
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 28 Dec 2010.