The Treatment of Hepatocirrhosis and Portal Hypertension

NCT02778425 | Completed DMC

• 1 other identifier: 201602-QILU
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• The primary outcome was the hepatic recompensation rate based on Baveno VII criteria after 1-year follow-up.

  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 suppression of hepatitis B virus, and sustained abstinence from alcohol in alcoholic cirrhosis); (2)Symptomatic Resolution: Regression of ascites (discontinuation of diuretics), remission of hepatic encephalopathy (discontinuation of lactulose/rifaximin), and absence of recurrent variceal bleeding (for at least 12 months); (3)Improvement in Liver Function: Stable improvement in liver function tests (albumin, INR, bilirubin). Assessed via lab tests (HCV RNA, HBV DNA, albumin, INR, bilirubin) and clinical evaluation (ascites, encephalopathy, endoscopy). Reported as binary (Yes/No).

  2 years

Secondary Outcomes (3)

• The secondary endpoints were severe variceal recurrence and mortality during the 2-year follow-up

  2 years

• 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.

  2 years

• The secondary endpoints were changes in Child-Pugh Score, MELD Score, and Physiological Parameters during the follow-up.

  2 years

Study Arms (7)

Secondary prevention-1

EXPERIMENTAL

Endoscopic therapy+ beta blockers

Procedure: Endoscopic therapy+ beta blockers

Secondary prevention-2

EXPERIMENTAL

Endoscopic therapy+ PSE+beta blockers

Procedure: Endoscopic therapy+ PSE+beta blockers

Primary prevention-1

EXPERIMENTAL

Beta blockers

Procedure: beta blockers

Primary prevention-2

EXPERIMENTAL

Endoscopic therapy

Procedure: Endoscopic therapy

Primary prevention-3

EXPERIMENTAL

Endoscopic therapy+ PSE

Procedure: Endoscopic therapy+ PSE

Acute bleeding-1

EXPERIMENTAL

Somatostatin+endoscopic therapy

Procedure: Somatostatin+Endoscopic therapy

Acute bleeding-2

EXPERIMENTAL

Somatostatin+endoscopic therapy+PSE

Procedure: Somatostatin+Endoscopic therapy+PSE

Interventions

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 (propranolol) was applied to patients according to the Baveno VI recommendations if there were no contraindications.

Secondary prevention-1

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 (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.

Secondary prevention-2

beta blockers PROCEDURE

A standard dose of NSBB (propranolol) was applied to the primary prevention patients according to the Baveno VI recommendations if there were no contraindications.

Primary prevention-1

Endoscopic therapy PROCEDURE

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

Primary prevention-2

Endoscopic therapy+ PSE PROCEDURE

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.

Primary prevention-3

Somatostatin+Endoscopic therapy 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).

Acute bleeding-1

Somatostatin+Endoscopic therapy+PSE 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.

Acute bleeding-2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yanjing Gao: lead
• Shandong Provincial Hospital: collaborator
• Jinan Military General Hospital: collaborator

Study Sites (1)

Department of Gastroenterology,Qilu Hospital,Shandong University

Jinan, Shandong, 250012, China

Location

Related Publications (2)

• Wei M, Chen Y, Wang M, Li J, Zeng Y, Sun X, Zhang A, Liu X, Zhou T, Gao Y. 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. J Gastroenterol. 2023 Nov;58(11):1144-1153. doi: 10.1007/s00535-023-02027-1. Epub 2023 Jul 24.

  PMID: 37486372 DERIVED

• 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.

  PMID: 33638769 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Hypertension, Portal; Hypersplenism; Thrombocytopenia

Interventions

Adrenergic beta-Antagonists

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Splenic Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Blood Platelet Disorders; Hematologic Diseases; Cytopenia

Intervention Hierarchy (Ancestors)

Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Officials

• Yanjing Gao Yanjing Gao, PhD.MD

  Qilu Hospital,Shandong Universty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice presidengt of Department of Gastroenterology of Qilu Hospital

Study Record Dates

• First Submitted: May 8, 2016
• First Posted: May 19, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: February 14, 2025

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2021.1
• Access Criteria: Open Access

Locations

CN (1)