CirrhosisNCT00888784
Secondary Prophylaxis Gastric Variceal 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
The investigators conducted a randomized, controlled trial (RCT) to study the efficacy of beta blockers versus endoscopic cyanoacrylate injection in the prevention of gastric variceal (GOV2 or IGV1) rebleeding and improvement in survival. Read more about this study
- Who is it for?
- Ages 10 to 70 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?
- Yes, some participants may receive a placebo
- How many people
- 64 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 10 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with GOV2 without esophageal varix or IGV1, who had bled from GV were included
Who cannot join
- Presence of esophageal varix
- GOV2 with GOV1; contraindications to beta-blocker therapy and cyanoacrylate injection
- Prior injection of cyanoacrylate or sclerotherapy for GV or GV ligation, transjugular intrahepatic portosystemic shunt, balloon-occluded retrograde transvenous obliteration, balloon-occluded endoscopic injection sclerotherapy of GV, shunt operation for prevention of rebleeding from GV
- Patients already on beta-blocker or nitrates
- Undetermined origin of bleeding from esophageal varix or gastric varix
- Hepatic encephalopathy grade III/IV
Show all 13Show fewer
- Hepatorenal syndrome
- Hepatocellular carcinoma
- Presence of deep jaundice (serum bilirubin > 10 mg/dl)
- Uremia
- Cerebrovascular accident
- Cardiorespiratory failure
- Pregnancy or patients not giving informed consent for endoscopic procedures
Trial locations and contacts
1 site in 1 country.
India1 site
G B Pant Hospital
New Delhi, National Capital Territory of Delhi, 110002
About this study
Official title: Endoscopic Cyanoacrylate Injection Versus Beta-Blockers for Secondary Prophylaxis of Gastric Variceal Bleed
The investigators conducted a randomized, controlled trial (RCT) to study the efficacy of beta blockers versus endoscopic cyanoacrylate injection in the prevention of gastric variceal (GOV2 or IGV1) rebleeding and improvement in survival.
- 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
Endoscopic Cyanoacrylate injection in gastric varix
beta-blocker (propranolol)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 1. Endoscopic Cyanoacrylate injection | Active comparator | Endoscopic Cyanoacrylate injection in the gastric varix Receives: Procedure: Endoscopic Cyanoacrylate injection |
| 2. Beta-blocker | Placebo comparator | 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.
Rebleeding from GV or death
Measured: Overall Study
Secondary outcomes (1)
Increase or decrease in the size of GV, appearance of new esophageal varices and appearance or worsening of portal hypertensive gastropathy and complications.
Measured: Overall Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 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
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Govind Ballabh Pant Hospital
- Sponsor type
- Other government
- Investigators
- Shiv K Sarin, MD, DM, Principal investigator, Director, G B Pant Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888784
- Sponsor's protocol ID
- SRM03
- Status last verified
- Apr 2009
- First submitted
- 27 Apr 2009
- Last updated
- 28 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Mishra SR, Chander Sharma B, Kumar A, Sarin SK. Endoscopic cyanoacrylate injection versus beta-blocker for secondary prophylaxis of gastric variceal bleed: a randomised controlled trial. Gut. 2010 Jun;59(6):729-35. doi: 10.1136/gut.2009.192039.
PubMed 20551457
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Cyanoacrylate Injection Versus Beta-Blockers for Secondary Prophylaxis of Gastric Variceal Bleed
- ClinicalTrials.gov ID
- NCT00888784
- Acronym / sponsor ID
- SRM03
- Conditions
- Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 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
- 28 Apr 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.
The investigators conducted a randomized, controlled trial (RCT) to study the efficacy of beta blockers versus endoscopic cyanoacrylate injection in the prevention of gastric variceal (GOV2 or IGV1) rebleeding and improvement in survival.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Endoscopic Cyanoacrylate injection | Active comparator | Procedure: Endoscopic Cyanoacrylate injectionEndoscopic Cyanoacrylate injection in the gastric varix |
| 2. Beta-blocker | Placebo comparator | Drug: beta-blocker (propranolol)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
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with GOV2 without esophageal varix or IGV1, who had bled from GV were included
Key exclusion criteria (13 listed)
- Presence of esophageal varix
- GOV2 with GOV1; contraindications to beta-blocker therapy and cyanoacrylate injection
- Prior injection of cyanoacrylate or sclerotherapy for GV or GV ligation, transjugular intrahepatic portosystemic shunt, balloon-occluded retrograde transvenous obliteration, balloon-occluded endoscopic injection sclerotherapy of GV, shunt operation for prevention of rebleeding from GV
- Patients already on beta-blocker or nitrates
- Undetermined origin of bleeding from esophageal varix or gastric varix
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 injectionEndoscopic Cyanoacrylate injection in gastric varix | Procedure or surgery | 1. Endoscopic Cyanoacrylate injection |
| beta-blocker (propranolol)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. | Drug | 2. Beta-blocker |
Primary outcome
Rebleeding from GV or death
Time frame: Overall Study
1 secondary outcome
Increase or decrease in the size of GV, appearance of new esophageal varices and appearance or worsening of portal hypertensive gastropathy and complications.
Time frame: Overall Study
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 Apr 2009.
- Derived from this study: PubMed 20551457Mishra SR, Chander Sharma B, Kumar A, Sarin SK. Endoscopic cyanoacrylate injection versus beta-blocker for secondary prophylaxis of gastric variceal bleed: a randomised controlled trial. Gut. 2010 Jun;59(6):729-35. doi: 10.1136/gut.2009.192039.
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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
Director, 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 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 13 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 Apr 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. 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?
Rebleeding from GV or death (time frame: Overall Study). 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 NCT00888784, 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 Apr 2009.