Primary Prophylaxis of Gastric Varix Bleed
This study has been completed.
Sponsor:
Govind Ballabh Pant Hospital
Information provided by:
Govind Ballabh Pant Hospital
ClinicalTrials.gov Identifier:
NCT00905996
First received: May 19, 2009
Last updated: May 20, 2009
Last verified: May 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Cirrhosis |
Procedure: Endoscopic cyanoacrylate injection Drug: Beta-blocker (propranolol) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | A Randomized Controlled Trial Comparing Cyanoacrylate Injection Versus Beta-Blockers Versus No Treatment for Primary Prophylaxis of Gastric Variceal Bleed |
Resource links provided by NLM:
Genetics Home Reference related topics:
North American Indian childhood cirrhosis
U.S. FDA Resources
Further study details as provided by Govind Ballabh Pant Hospital:
Primary Outcome Measures:
- Bleeding from gastric varix or death [ Time Frame: Within 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 74 |
| Study Start Date: | August 2006 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Endoscopic Cyanoacrylate injection
Endoscopic injection of cyanoacrylate in the gastric varix until obturation
|
Procedure: Endoscopic cyanoacrylate injection
Endoscopic cyanoacrylate injection in gastric varix
Other Name: Glue injection in gastric varix
|
|
No Intervention: No Intervention
No treatment offered for gastric varix
|
|
|
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.
|
Drug: Beta-blocker (propranolol) |
Detailed Description:
Patients are followed up every 3 months or at the time of end point or complications.
Eligibility| Ages Eligible for Study: | 12 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with GOV2 with eradicated esophageal varix or IGV1, who had never bled from gastric varix were included.
Exclusion Criteria:
- 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
- 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
Contacts and Locations More Information
No publications provided by Govind Ballabh Pant Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr S K Sarin, Department of Gastroenterology, G B Pant Hospital, New Delhi, India |
| ClinicalTrials.gov Identifier: | NCT00905996 History of Changes |
| Other Study ID Numbers: | SRM04 |
| Study First Received: | May 19, 2009 |
| Last Updated: | May 20, 2009 |
| Health Authority: | India: Ministry of Health |
Additional relevant MeSH terms:
|
Liver Cirrhosis Fibrosis Liver Diseases Digestive System Diseases Pathologic Processes Adrenergic beta-Antagonists Propranolol Adrenergic Antagonists Adrenergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Antihypertensive Agents Vasodilator Agents |
ClinicalTrials.gov processed this record on May 19, 2013