Non Cirrhotic Portal HypertensionPhase 3NCT01000779
Comparison of Endoscopic Variceal Ligation (EVL) With Propranolol in Non Cirrhotic Portal Hypertension (NCPH)
A Phase 3 study testing Propranolol and multi band ligator for esophageal varices in people with Non Cirrhotic Portal Hypertension, run by Govind Ballabh Pant Hospital at 1 site in India.
Trial summary
Background: Variceal bleeding is a major cause of morbidity and mortality in patients with Non Cirrhotic Portal Hypertension (NCPH). Beta blockers (BB) and endoscopic variceal ligation (EVL) have been used to prevent rebleeding in these patients, largely based on data from cirrhotic patients. Read more about this study
- Who is it for?
- Ages 2 to 75 years
- Conditions the study is for
- Non Cirrhotic Portal Hypertension
- What is being tested?
- Propranolol and multi band ligator for esophageal varices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2005to Oct 2009
- Phase
- Phase 3
- 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 2 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with Non Cirrhotic Portal Hypertension (NCPH) presenting to our Liver Diseases Follow-up Clinic with history of hemetemesis and/or malena within the past 6 weeks and proven to have esophageal varices as the bleeding source on upper GI endoscopy
Who cannot join
- A history of surgery for portal hypertension
- Patients already on a EST, EVL, or glue injection program before presenting to our hospital
- Patients already on beta blockers for primary prophylaxis of variceal bleed
- Severe cardiopulmonary or renal disease
- Bradycardia (basal heart rate, <50 beats per minute [bpm]) or complete heart block
- A history of severe side effects or contraindications to β- blockers, like bronchial asthma, diabetes mellitus, heart failure, peripheral vascular disease, prostatic hypertrophy, or arterial hypotension (systolic blood pressure <90 mm Hg)
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- Refusal to give informed written consent to participate in the trial
- Patients bleeding from gastric varices or Portal Hypertensive Gastropathy (PHG).
- Patients who had a failure of primary hemostasis during acute bleed were also excluded.
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Gastroenterology, GB Pant Hospital,
New Delhi, National Capital Territory of Delhi, 110002
About this study
Official title: Comparison of Endoscopic Variceal Ligation (EVL) and Propranolol in Secondary Prophylaxis of Variceal Bleeding in Patients With Non Cirrhotic Portal Hypertension (NCPH): A Prospective Randomized Controlled Trial
Background: Variceal bleeding is a major cause of morbidity and mortality in patients with Non Cirrhotic Portal Hypertension (NCPH). Beta blockers (BB) and endoscopic variceal ligation (EVL) have been used to prevent rebleeding in these patients, largely based on data from cirrhotic patients. Endotherapy in the form of EST has been well studied in preventing rebleed in patients with NCPH. Initial studies showed that EST significantly reduced the rebleeding rate in patients of NCPH. Data from these studies suggests a rebleed rate of approximately 25% at 2yr and 35% at 5 years.
Beta blockers have been found to be quite effective in both primary as well as secondary prophylaxis of variceal bleeding in cirrhotic and are accepted mode of treatment. In contrast to liver cirrhosis, published data on the effect of beta blocker therapy on NCPH are scanty. Animal data and human data suggests that beta blockers reduce portal pressure in patients with NCPH. In two placebo controlled trials of propranolol on secondary prophylaxis of variceal bleeding in non cirrhotic patients. both studies demonstrated the efficacy of propranolol in decreasing rebleed rate. However, no comparisons hae been made with EVL till date.
Hypothesis: The investigators hypothesis that In patients with NCPH, treatment with beta blockers will lead to reduction in portal pressure and decrease in portosystemic shunting leading to reduction in variceal rebleeding Aim of the study: Aim: To compare the efficacy and safety of Propranolol and EVL in the prevention of variceal rebleeding in patients with NCPH.
- Conditions
- Non Cirrhotic Portal Hypertension
- Being tested
- Propranolol, multi band ligator for esophageal varices
- Keywords
- Non Cirrhotic Portal Hypertension, secondary prophylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
upto 320mg/day maximum
multi band ligator for esophageal varicesDevice
to obliterate esophageal varices
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Variceal Ligation | Active comparator | endoscopic therapy to obliterate varices Receives: Device: multi band ligator for esophageal varices |
| Propranolol | Active comparator | drugs to decrease portal pressure Receives: Drug: Propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebleed, death
Measured: At least 3 months after last enrollment
Secondary outcomes (1)
Adverse effects of EVL or drug therapy, variceal eradication on EVL, variceal recurrence after eradication on EVL, decrease in variceal grade in the propranolol limb
Measured: At least 3 months after last enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startJan 2005
- Primary completionOct 2009
- Study completionOct 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 Non Cirrhotic Portal HypertensionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
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, New Delhi, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000779
- Sponsor's protocol ID
- NG001
- Status last verified
- Oct 2009
- First submitted
- 22 Oct 2009
- Last updated
- 22 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sarin SK, Gupta N, Jha SK, Agrawal A, Mishra SR, Sharma BC, Kumar A. Equal efficacy of endoscopic variceal ligation and propranolol in preventing variceal bleeding in patients with noncirrhotic portal hypertension. Gastroenterology. 2010 Oct;139(4):1238-45. doi: 10.1053/j.gastro.2010.06.017. Epub 2010 Jun 12.
PubMed 20547163
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Endoscopic Variceal Ligation (EVL) and Propranolol in Secondary Prophylaxis of Variceal Bleeding in Patients With Non Cirrhotic Portal Hypertension (NCPH): A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01000779
- Acronym / sponsor ID
- NG001
- Conditions
- Non Cirrhotic Portal Hypertension
- Keywords
- Non Cirrhotic Portal Hypertension, secondary prophylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Govind Ballabh Pant HospitalOther government
- Study start
- Jan 2005
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 23 Oct 2009 (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: Variceal bleeding is a major cause of morbidity and mortality in patients with Non Cirrhotic Portal Hypertension (NCPH). Beta blockers (BB) and endoscopic variceal ligation (EVL) have been used to prevent rebleeding in these patients, largely based on data from cirrhotic patients. Endotherapy in the form of EST has been well studied in preventing rebleed in patients with NCPH. Initial studies showed that EST significantly reduced the rebleeding rate in patients of NCPH. Data from these studies suggests a rebleed rate of approximately 25% at 2yr and 35% at 5 years.
Beta blockers have been found to be quite effective in both primary as well as secondary prophylaxis of variceal bleeding in cirrhotic and are accepted mode of treatment. In contrast to liver cirrhosis, published data on the effect of beta blocker therapy on NCPH are scanty. Animal data and human data suggests that beta blockers reduce portal pressure in patients with NCPH. In two placebo controlled trials of propranolol on secondary prophylaxis of variceal bleeding in non cirrhotic patients. both studies demonstrated the efficacy of propranolol in decreasing rebleed rate. However, no comparisons hae been made with EVL till date.
Hypothesis: The investigators hypothesis that In patients with NCPH, treatment with beta blockers will lead to reduction in portal pressure and decrease in portosystemic shunting leading to reduction in variceal rebleeding Aim of the study: Aim: To compare the efficacy and safety of Propranolol and EVL in the prevention of variceal rebleeding in patients with NCPH.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Variceal Ligation | Active comparator | Device: multi band ligator for esophageal varicesendoscopic therapy to obliterate varices |
| Propranolol | Active comparator | Drug: Propranololdrugs to decrease portal pressure |
Who may qualify
- Ages
- 2 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Non Cirrhotic Portal Hypertension (NCPH) presenting to our Liver Diseases Follow-up Clinic with history of hemetemesis and/or malena within the past 6 weeks and proven to have esophageal varices as the bleeding source on upper GI endoscopy
Key exclusion criteria (9 listed)
- A history of surgery for portal hypertension
- Patients already on a EST, EVL, or glue injection program before presenting to our hospital
- Patients already on beta blockers for primary prophylaxis of variceal bleed
- Severe cardiopulmonary or renal disease
- Bradycardia (basal heart rate, <50 beats per minute [bpm]) or complete heart block
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 |
|---|---|---|
| Propranololupto 320mg/day maximum | Drug | Propranolol |
| multi band ligator for esophageal varicesto obliterate esophageal varices | Device | Endoscopic Variceal Ligation |
Primary outcome
Rebleed, death
Time frame: At least 3 months after last enrollment
1 secondary outcome
Adverse effects of EVL or drug therapy, variceal eradication on EVL, variceal recurrence after eradication on EVL, decrease in variceal grade in the propranolol limb
Time frame: At least 3 months after last enrollment
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 22 Dec 2010.
- Derived from this study: PubMed 20547163Sarin SK, Gupta N, Jha SK, Agrawal A, Mishra SR, Sharma BC, Kumar A. Equal efficacy of endoscopic variceal ligation and propranolol in preventing variceal bleeding in patients with noncirrhotic portal hypertension. Gastroenterology. 2010 Oct;139(4):1238-45. doi: 10.1053/j.gastro.2010.06.017. Epub 2010 Jun 12.
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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, New Delhi, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Propranolol and multi band ligator for esophageal varices in people with Non Cirrhotic 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 1 inclusion and 9 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 22 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Rebleed, death (time frame: At least 3 months after last enrollment). 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 NCT01000779, 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 22 Dec 2010.