Clinical trial NCT02778425: The Treatment of Hepatocirrhosis and Portal Hypertension
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Cirrhosis
Portal Hypertension
Keywords: Partial splenic embolization
Hypersplenism
Thrombocytopenia
Portal hypertension
Gastroesophageal varices
Secondary prophylaxis
Endoscopic variceal ligation
Non-selective beta-blocker
hepatic recompensation
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
Collaborators: name: Shandong Provincial Hospital
name: Jinan Military General Hospital
First posted: 2016-05-19
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The primary endpoint was variceal rebleeding
timeFrame: 2 years
measure: The primary outcome was the hepatic recompensation rate based on Baveno VII criteria after 1-year follow-up.
timeFrame: 2 years
Secondary outcomes:
measure: The secondary endpoints were severe variceal recurrence and mortality during the 2-year follow-up
timeFrame: 2 years
measure: 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.
timeFrame: 2 years
measure: The secondary endpoints were changes in Child-Pugh Score, MELD Score, and Physiological Parameters during the follow-up.
timeFrame: 2 years
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology,Qilu Hospital,Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital,Shandong Universty
name: Yanjing Gao Yanjing Gao, PhD.MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sun X, Zhang A, Zhou T, Wang M, Chen Y, Zhou T, Chen X, Xiu A, Peng Z, Cheng B, Liu X, Gao Y. Partial splenic embolization combined with endoscopic therapies and NSBB decreases the variceal rebleeding rate in cirrhosis patients with hypersplenism: a multicenter randomized controlled trial. Hepatol Int. 2021 Jun;15(3):741-752. doi: 10.1007/s12072-021-10155-0. Epub 2021 Feb 27.