NCT02778425

The Treatment of Hepatocirrhosis and Portal Hypertension

Partial Splenic Embolization Combined with Endoscopic Therapies and NSBB Decreases the Variceal Rebleeding Rate and Increases Recompensation Rate in Cirrhosis Patients with Hypersplenism: a Multicenter Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Yanjing Gao · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study compare the efficiency of partial splenic embolization +endoscopical therapy with endoscopical therapy alone in gastroesophageal variceal haemorrhage accompanied with splenomegaly or hypersplenism of hepatocirrhosis and portal hypertension treatment.

Detailed description

Endoscopic therapy is the mature treatment of gastroesophageal variceal haemorrhage and PSE is an effective method for treatment of the hypersplenism and portal hypertension. Existing researches show that endoscopic therapy + PSE is more effective than endoscopic therapy alone in prevention of esophageal varices bleeding recurrence in the patients with liver cirrhosis. However, there is few articles which proved long-term effectiveness of endoscopic therapy + PSE, it needs further research on this issue. This study compares the efficiency of partial splenic embolization +endoscopic therapy with endoscopic therapy alone in the treatment of gastroesophageal variceal haemorrhage accompanied with splenomegaly or hypersplenism in the patients with hepatocirrhosis and portal hypertension.

Conditions

• Hepatic Cirrhosis
• Portal Hypertension

Interventions

Type	Name	Description
PROCEDURE	Endoscopic therapy+ beta blockers	Endoscopic variceal ligation (EVL) is for the secondary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).A standard dose of NSBB (propranolol) was applied to patients according to the Baveno VI recommendations if there were no contraindications.
PROCEDURE	Endoscopic therapy+ PSE+beta blockers	Endoscopic variceal ligation (EVL) is for the secondary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).A standard dose of NSBB (propranolol) was applied to patients according to the Baveno VI recommendations if there were no contraindications.Partial splenic embolization (PSE) is one of the intra-arterial therapeutic approaches to embolize 60-80% splenic blood flow.
PROCEDURE	beta blockers	A standard dose of NSBB (propranolol) was applied to the primary prevention patients according to the Baveno VI recommendations if there were no contraindications.
PROCEDURE	Endoscopic therapy	Endoscopic variceal ligation (EVL) is for the primary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).
PROCEDURE	Endoscopic therapy+ PSE	Endoscopic variceal ligation (EVL) is for the primary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).Partial splenic embolization (PSE) is one of the intra-arterial therapeutic approaches to embolize 60-80% splenic blood flow.
PROCEDURE	Somatostatin+Endoscopic therapy	The first dose of 250 was injected intravenously, followed by a continuous iv infusion of 250 for 3-5 days. Endoscopic variceal ligation (EVL) is for the acute bleeding of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).
PROCEDURE	Somatostatin+Endoscopic therapy+PSE	The first dose of 250 was injected intravenously, followed by a continuous iv infusion of 250 for 3-5 days. Endoscopic variceal ligation (EVL) is for the acute bleeding of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).Partial splenic embolization (PSE) is one of the intra-arterial therapeutic approaches to embolize 60-80% splenic blood flow.

Timeline

• Start date: 2016-02-01
• Primary completion: 2019-12-01
• Completion: 2020-01-01
• First posted: 2016-05-19
• Last updated: 2025-02-14

Locations

1 site across 1 country: China