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Long-acting Octreotide Prevents Variceal Rebleeding in Patients with Portal Hypertension

Long-acting Octreotide Prevents Variceal Rebleeding in Patients with Portal Hypertension

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004384
Enrollment
Unknown
Registered
2014-03-15
Start date
2014-03-20
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

liver cirrosis, portal hypertension

Interventions

20mg LAR group:20mg long-acting octreotide muscular injection monthly
40mg LAR group:40mg long-acting octreotide muscular injection monthly

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. absence of documented hepatocellular carcinoma; 2. no decompensated cardiorespiratory disease; 3. no infection; 4. no treatment with somatostatin or any synthetic analog in the previous six weeks and no known hypersensitivity reaction to octreotide; 5. no severe coagulopathy (prothrombin more than 40% and platelets more than 50 g/L); 6. declared abstinence from alcohol; 7. moderate to severe liver failure with liver cirrhosis (Pugh's score 7-10); 8. history of esophageal varices assessed by endoscopic observation; 9. suffered from rebleeding despite undergoing repeated endoscopic variceal ligation; 10. began taking a beta blocker (non-selective) at the time of first variceal ligation, during which dose was adjusted to reduce baseline heart rate by 25% or to reach a pulse rate of 55/min; 11. currently using the same beta blocker to prevent variceal rebleeding and remained on the agent for the duration of the study period; 12. no current use of any other drug therapy known to have an influence on portal pressure.

Exclusion criteria

Exclusion criteria: 1. Hepatocellular carcinoma; 2. Complicated with cardiorespiratory disease; 3. Infection; 4. Treated by somatostatin or any synthetic analog and known hypersensitivity reaction to octreotide; 5. severe coagulopathy (prothrombin more than 40% and platelets more than 50 G/L); 6. abstinence from alcohol; 7. currently use of any other drug therapy except beta-blockers known to have an influence on portal pressure.

Design outcomes

Primary

MeasureTime frame
HVPG (mmHg);VEGF (pg/mL);

Countries

China

Contacts

Public ContactGuang-Wen Zhou

Shanghai Sixth People's Hospital

gwzhousfph@gmail.com+86 13916662683

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026