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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02778425
Other study ID # 201602-QILU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2016
Est. completion date January 2020

Study information

Verified date September 2021
Source Qilu Hospital of Shandong University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date January 2020
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Patients aged between 18 and 75 years - Patients who had recovered from an episode of VH or patients who had survived from acute VH and there was no bleeding for consecutive 5 days - Patients with a diagnosis of liver cirrhosis and portal hypertension on clinical examination, laboratory test, and imaging or histological examination - Patients with hypersplenism and thrombocytopenia (platelets < 100,000/µL). Exclusion criteria : - Previous therapy (splenectomy, PSE, EVL, tissue adhesive injection, or usage of (NSBB) to prevent rebleeding - Bleeding from isolated gastric or ectopic varices - Hepatocellular carcinoma or other malignant tumors - Contraindications for the use of NSBBs, hepatic failure, and Child-Pugh class C with large amount ascites, or grade 3-5 hepatic encephalopathy, or prothrombin activity = 40% - Hepatic failure - Contraindications for PSE - Pregnancy and lactation - Inability to sign the informed consent.

Study Design


Intervention

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.
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.
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.
Endoscopic therapy
Endoscopic variceal ligation (EVL) is for the primary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).
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.
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).
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.

Locations

Country Name City State
China Department of Gastroenterology,Qilu Hospital,Shandong University Jinan Shandong

Sponsors (3)

Lead Sponsor Collaborator
Yanjing Gao Jinan Military General Hospital, Shandong Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary endpoint was variceal rebleeding The rebleeding rate of the varices in the EP group will compared to that in the E group during the follow up. 2 years
Secondary The secondary endpoints were severe variceal recurrence and mortality during the 2-year follow-up The recurrence rate of the varices in the EP group will compared to that in the E group during the follow up. 2 years
Secondary Changes of the peripheral blood cell counts including white blood cell, red blood cell, and platelate counts in both group during 2-years follow up. The physiological parameters including white blood cell (*10^9/L), red blood cell (*10^12/L) and platelte(*10^12/L) will compared between the two groups. 2 years
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