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The purpose of this study was to compare the effects of partial splenic artery embolization combined with endoscopic treatment and endoscopic treatment alone on portal hypertension in cirrhosis with hyperplenism or splenomegaly in esophageal and gastric varices.
Although there have been many consensus opinions on the treatment of cirrhosis patients with esophageal and gastric variceal hemorrhage, there is no standard to follow for the treatment of cirrhosis patients with esophageal and gastric variceal hemorrhage combined with hypersplenism or splenomegalism, and studies show that the patients with cirrhosis combined with severe hypersplenism account for about 33%. It has been reported that partial splenic artery embolization is effective in the treatment of hypersplenism or splenomegaly caused by portal hypertension in liver cirrhosis, but for liver cirrhosis with esophageal and gastric varices hemorrhage in port or spleen large combined at the same time of endoscopic treatment should joint partial splenic artery embolization treatment remains controversial.Therefore, it is urgent to further study the effect of partial splenic artery embolization combined with endoscopic therapy on cirrhosis with esophageal and gastric variceal hemorrhage combined with hyperspleenism or splenomegaly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secondary prevention-1 | Experimental | Endoscopic therapy+ beta blockers |
|
| Secondary prevention-2 | Experimental | Endoscopic therapy+ PSE+beta blockers |
|
| Primary prevention-1 | Experimental | Endoscopic therapy |
|
| Primary prevention-2 | Experimental | Endoscopic therapy+ PSE |
|
| Acute bleeding-1 | Experimental | Endoscopic therapy+somatostatin |
|
| Acute bleeding-2 | Experimental | Endoscopic therapy+PSE+somatostatin |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic therapy+ beta blockers | Procedure | 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 (carvedilol) was applied to patients according to the Baveno VI recommendations if there were no contraindications. |
| Measure | Description | Time Frame |
|---|---|---|
| rebleeding | the rate of rebleeding after endoscopic therapy | 2 to 30days |
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Secondary prevention:
Inclusion Criteria:
Exclusion Criteria:
Primary prevention:
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Exclusion Criteria:
Acute bleeding:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanjing Gao, PhD.MD | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital , Shandong University | Jinan | Shandong | China |
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|
| Endoscopic therapy+ PSE+beta blockers | Procedure | 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 (carvedilol) 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. |
|
| Endoscopic therapy | Procedure | Endoscopic variceal ligation (EVL) is for the secondary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV). |
|
| Endoscopic therapy+ PSE | Procedure | Endoscopic variceal ligation (EVL) is for the secondary 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. |
|
| Endoscopic therapy+Somatostatin | Procedure | 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). |
|
| Endoscopic therapy+PSE+Somatostatin | Procedure | 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. |
|
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D004932 | Esophageal and Gastric Varices |
| D006971 | Hypersplenism |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D006975 | Hypertension, Portal |
| D013158 | Splenic Diseases |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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