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Interventional Embolization of Spontaneous Portosystemic Shunts for the Management of Recurrent or Persistent Hepatic Encephalopathy: A Prospective, Non-Randomized, Cohort Study

Interventional Embolization of Spontaneous Portosystemic Shunts for the Management of Recurrent or Persistent Hepatic Encephalopathy: A Prospective, Non-Randomized, Cohort Study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072189
Enrollment
Unknown
Registered
2023-06-06
Start date
2023-06-15
Completion date
Unknown
Last updated
2023-10-22

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

Conditions

Cirrhosis Hepatic Encephalopathy

Interventions

Embolization group:Interventional embolization combined with standard medical therapy

Sponsors

Mengchao Hepatobiliary Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Clear diagnosis of cirrhosis accompanied by persistent or recurrent hepatic encephalopathy (HE); 2. Definite presence of spontaneous portal shunts with a diameter larger than 10 mm, confirmed through imaging; 3. Age between 18 and 75 years (inclusive), with no gender restrictions; 4. Mandatory requirement for routine blood tests: hemoglobin (HB) levels >= 80g/L, absolute neutrophil count (ANC) >= 1.5 x 10^9/L, and platelet count (PLT) >= 50 x 10^9/L; 5. Anticipated life expectancy of more than 6 months; 6. Willingness to participate voluntarily in this clinical trial and ability to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Presence of comorbid malignancies; 2. History of splenic artery embolization, splenectomy, hepatectomy, liver transplantation, or surgical shunt; 3. History of transjugular intrahepatic portosystemic shunt (TIPS); 4. Child-Pugh score > 13; 5. Presence of refractory ascites; 6. Presence of active gastrointestinal bleeding; 7. Presence of psychiatric or neurological disorders; 8. Presence of other severe cardiopulmonary or renal diseases.

Design outcomes

Primary

MeasureTime frame
HE-free survival;

Secondary

MeasureTime frame
Overall survival;Changes in liver function;Safety;

Countries

China

Contacts

Public ContactGuo Wuhua

Mengchao Hepatobiliary Hospital of Fujian Medical University

guowuhua@aliyun.com+86 187 5912 2356

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026