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Secondary Prophylaxis Gastric Variceal Bleed

Endoscopic Cyanoacrylate Injection Versus Beta-Blockers for Secondary Prophylaxis of Gastric Variceal Bleed

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00888784
Enrollment
64
Registered
2009-04-28
Start date
2006-08-31
Completion date
2009-01-31
Last updated
2009-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis

Brief 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.

Interventions

Endoscopic Cyanoacrylate injection in gastric varix

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.

Sponsors

Govind Ballabh Pant Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Patients with GOV2 without esophageal varix or IGV1, who had bled from GV were included

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frame
Rebleeding from GV or deathOverall Study

Secondary

MeasureTime frame
Increase or decrease in the size of GV, appearance of new esophageal varices and appearance or worsening of portal hypertensive gastropathy and complications.Overall Study

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026