CirrhosisNCT00905996
Primary Prophylaxis of Gastric Varix Bleed
A study testing Endoscopic cyanoacrylate injection and Beta-blocker (propranolol) in people with Cirrhosis, run by Govind Ballabh Pant Hospital at 1 site in India.
Trial summary
In patients who have never bled from gastric varix (GOV2 and IGV1), cyanoacrylate injection will be better than both beta-blocker therapy and no treatment in prevention of gastric variceal bleed. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Cirrhosis
- What is being tested?
- Endoscopic cyanoacrylate injection and Beta-blocker (propranolol)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2006to Jan 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
- Patients with GOV2 with eradicated esophageal varix or IGV1, who had never bled from gastric varix were included.
Who cannot join
- Only esophageal varix, GOV1 with GOV2, acute bleed or past history of bleed from gastric varix, contraindications to beta-blocker therapy and cyanoacrylate injection.
- Prior injection of cyanoacrylate or sclerotherapy or variceal ligation or transjugular intrahepatic portosystemic shunt or balloon-occluded retrograde transvenous obliteration or balloon-occluded endoscopic injection sclerotherapy of gastric varix for prevention of bleeding from GV
- Patients already on beta-blocker or nitrates
- Undetermined origin of bleeding from esophageal varix or gastric varix
- Hepatic encephalopathy grade III/IV
- Hepatorenal syndrome
Show all 12Show fewer
- Hepatocellular carcinoma
- Presence of deep jaundice (serum bilirubin > 10 mg/dl)
- Uremia
- Cerebrovascular accident
- Cardiorespiratory failure
- Pregnancy and patients not giving informed consent for endoscopic procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparing Cyanoacrylate Injection Versus Beta-Blockers Versus No Treatment for Primary Prophylaxis of Gastric Variceal Bleed
In patients who have never bled from gastric varix (GOV2 and IGV1), cyanoacrylate injection will be better than both beta-blocker therapy and no treatment in prevention of gastric variceal bleed. The investigators conducted a randomized controlled trial in patients with gastric varix (GOV2 and IGV1) who never bled before, to study the efficacy of treatment with cyanoacrylate injection versus beta-blocker versus no treatment in prevention of first bleed from gastric varices.
Read the detailed description
Patients are followed up every 3 months or at the time of end point or complications.
- Conditions
- Cirrhosis
- Being tested
- Endoscopic cyanoacrylate injection, Beta-blocker (propranolol)
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic cyanoacrylate injectionProcedure or surgery
Also called Glue injection in gastric varix
Endoscopic cyanoacrylate injection in gastric varix
Beta-blocker (propranolol)Drug
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Cyanoacrylate injection | Active comparator | Endoscopic injection of cyanoacrylate in the gastric varix until obturation Receives: Procedure: Endoscopic cyanoacrylate injection |
| No Intervention | No intervention | No treatment offered for gastric varix |
| Beta-blocker (propranolol) | Other | Beta-blocker (propranolol) was started at a dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose was increased every alternate day to achieve a target heart rate of 55/min or to the maximal dose to 360 mg/day if the medication was well tolerated and the systolic blood pressure was > 90 mm Hg. On the occurrence of intolerable adverse effects, systolic blood pressure < 90 mm Hg or pulse rate < 55/min, the dose of the medication was decreased step-wise, and eventually stopped if these adverse events persisted. Reintroduction of the medication was attempted if cessation of the medication did not result in improvement of the reported side-effect. Receives: Drug: Beta-blocker (propranolol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding from gastric varix or death
Measured: Within 2 years
Secondary outcomes (1)
Increase or decrease in the size of gastric varices, appearance of new esophageal varices and appearance or worsening of portal hypertensive gastropathy (PGP), complications
Measured: Within 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startAug 2006
- Primary completionJan 2009
- Study completionJan 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 CirrhosisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 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, New Delhi, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905996
- Sponsor's protocol ID
- SRM04
- Status last verified
- May 2009
- First submitted
- 19 May 2009
- Last updated
- 21 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Mishra SR, Sharma BC, Kumar A, Sarin SK. Primary prophylaxis of gastric variceal bleeding comparing cyanoacrylate injection and beta-blockers: a randomized controlled trial. J Hepatol. 2011 Jun;54(6):1161-7. doi: 10.1016/j.jhep.2010.09.031. Epub 2010 Nov 5.
PubMed 21145834
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Cyanoacrylate Injection Versus Beta-Blockers Versus No Treatment for Primary Prophylaxis of Gastric Variceal Bleed
- ClinicalTrials.gov ID
- NCT00905996
- Acronym / sponsor ID
- SRM04
- Conditions
- Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Govind Ballabh Pant HospitalOther government
- Study start
- Aug 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 21 May 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.
In patients who have never bled from gastric varix (GOV2 and IGV1), cyanoacrylate injection will be better than both beta-blocker therapy and no treatment in prevention of gastric variceal bleed. The investigators conducted a randomized controlled trial in patients with gastric varix (GOV2 and IGV1) who never bled before, to study the efficacy of treatment with cyanoacrylate injection versus beta-blocker versus no treatment in prevention of first bleed from gastric varices.
Detailed description
Patients are followed up every 3 months or at the time of end point or complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Cyanoacrylate injection | Active comparator | Procedure: Endoscopic cyanoacrylate injectionEndoscopic injection of cyanoacrylate in the gastric varix until obturation |
| No Intervention | No intervention | –No treatment offered for gastric varix |
| Beta-blocker (propranolol) | Other | Drug: Beta-blocker (propranolol)Beta-blocker (propranolol) was started at a dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose was increased every alternate day to achieve a target heart rate of 55/min or to the maximal dose to 360 mg/day if the medication was well tolerated and the systolic blood pressure was > 90 mm Hg. On the occurrence of intolerable adverse effects, systolic blood pressure < 90 mm Hg or pulse rate < 55/min, the dose of the medication was decreased step-wise, and eventually stopped if these adverse events persisted. Reintroduction of the medication was attempted if cessation of the medication did not result in improvement of the reported side-effect. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with GOV2 with eradicated esophageal varix or IGV1, who had never bled from gastric varix were included.
Key exclusion criteria (12 listed)
- Only esophageal varix, GOV1 with GOV2, acute bleed or past history of bleed from gastric varix, contraindications to beta-blocker therapy and cyanoacrylate injection.
- Prior injection of cyanoacrylate or sclerotherapy or variceal ligation or transjugular intrahepatic portosystemic shunt or balloon-occluded retrograde transvenous obliteration or balloon-occluded endoscopic injection sclerotherapy of gastric varix for prevention of bleeding from GV
- Patients already on beta-blocker or nitrates
- Undetermined origin of bleeding from esophageal varix or gastric varix
- Hepatic encephalopathy grade III/IV
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 |
|---|---|---|
| Endoscopic cyanoacrylate injectionAlso: Glue injection in gastric varixEndoscopic cyanoacrylate injection in gastric varix | Procedure or surgery | Endoscopic Cyanoacrylate injection |
| Beta-blocker (propranolol) | Drug | Beta-blocker (propranolol) |
Primary outcome
Bleeding from gastric varix or death
Time frame: Within 2 years
1 secondary outcome
Increase or decrease in the size of gastric varices, appearance of new esophageal varices and appearance or worsening of portal hypertensive gastropathy (PGP), complications
Time frame: Within 2 years
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 21 May 2009.
- Derived from this study: PubMed 21145834Mishra SR, Sharma BC, Kumar A, Sarin SK. Primary prophylaxis of gastric variceal bleeding comparing cyanoacrylate injection and beta-blockers: a randomized controlled trial. J Hepatol. 2011 Jun;54(6):1161-7. doi: 10.1016/j.jhep.2010.09.031. Epub 2010 Nov 5.
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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 study testing Endoscopic cyanoacrylate injection and Beta-blocker (propranolol) in people with Cirrhosis, 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 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 21 May 2009. 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?
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?
Bleeding from gastric varix or death (time frame: Within 2 years). 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 NCT00905996, 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 21 May 2009.