Secondary Prophylaxis Gastric Variceal Bleed

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888784
• Other study ID #: SRM03
• Status: Completed
• Phase: N/A
• First received: April 27, 2009
• Last updated: April 27, 2009
• Start date: August 2006
• Est. completion date: January 2009

Study information

• Verified date: April 2009
• Source: Govind Ballabh Pant Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cirrhosis

Intervention

Procedure:
• Endoscopic Cyanoacrylate injection
Endoscopic Cyanoacrylate injection in gastric varix

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.

Locations

Country	Name	City	State
India	G B Pant Hospital	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Govind Ballabh Pant Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rebleeding from GV or death		Overall Study	No
Secondary	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	Yes