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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.


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Study Design


Intervention

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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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