NCT02778425

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

Completed NA Last updated 11 February 2025

What this trial tests

NA trial testing Endoscopic therapy+ beta blockers in Hepatic Cirrhosis in 108 participants. Completed in 1 January 2020.

Timeline

1 February 2016

Primary endpoint
1 December 2019

1 January 2020

Quick facts

Lead sponsor	Yanjing Gao
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	108
Start date	1 February 2016
Primary completion	1 December 2019
Estimated completion	1 January 2020
Sites	1 location across China

Drugs / interventions tested

• Endoscopic therapy+ beta blockers
• Endoscopic therapy+ PSE+beta blockers
• beta blockers
• Endoscopic therapy
• Endoscopic therapy+ PSE
• Somatostatin+Endoscopic therapy
• Somatostatin+Endoscopic therapy+PSE

Conditions studied

• Hepatic Cirrhosis — all drugs for Hepatic Cirrhosis →
• Portal Hypertension — all drugs for Portal Hypertension →

Sponsor

Yanjing Gao — full company profile →

Who can join

Adults 18 to 75, any sex, with Hepatic Cirrhosis or Portal Hypertension. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The primary endpoint was variceal rebleeding
  Time frame: 2 years
  The rebleeding rate of the varices in the EP group will compared to that in the E group during the follow up.
• The primary outcome was the hepatic recompensation rate based on Baveno VII criteria after 1-year follow-up.
  Time frame: 2 years
  The hepatic recompensation rate based on Baveno VII criteria in the EP group will compared to that in the E group during the follow-up. Hepatic recompensation is a comprehensive assessment index defined as meeting all of the following criteria simultaneously: (1)Etiological Control: Removal/suppression/cure of the primary cause of cirrhosis (e.g., hepatitis C virus elimination, sustained suppressi

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Partial splenic embolization combined with endoscopic therapies and NSBB decreases the variceal rebleeding rate in cirrhosis patients with hypersplenism: a multicenter randomized controlled trial.
   Sun X, Zhang A, Zhou T, Wang M, et al · · 2021 · cited 18× · PMID 33638769 · DOI 10.1007/s12072-021-10155-0
2. Partial splenic embolization combined with endoscopic therapies and vasoconstrictive drugs reduces rebleeding in cirrhosis patients with acute variceal bleeding and hypersplenism: a multicenter randomized controlled trial.
   Wei M, Chen Y, Wang M, Li J, et al · · 2023 · cited 2× · PMID 37486372 · DOI 10.1007/s00535-023-02027-1