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The Treatment of Hepatocirrhosis and Portal Hypertension

Primary Purpose

Hepatic Cirrhosis, Portal Hypertension

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Endoscopic therapy+ beta blockers
Endoscopic therapy+ PSE+beta blockers
beta blockers
Endoscopic therapy
Endoscopic therapy+ PSE
Somatostatin+Endoscopic therapy
Somatostatin+Endoscopic therapy+PSE
Sponsored by
Yanjing Gao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Cirrhosis focused on measuring Partial splenic embolization, Hypersplenism, Thrombocytopenia, Portal hypertension, Gastroesophageal varices, Secondary prophylaxis, Endoscopic variceal ligation, Non-selective beta-blocker

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Gastroenterology,Qilu Hospital,Shandong University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Secondary prevention-1

Secondary prevention-2

Primary prevention-1

Primary prevention-2

Primary prevention-3

Acute bleeding-1

Acute bleeding-2

Arm Description

Endoscopic therapy+ beta blockers

Endoscopic therapy+ PSE+beta blockers

Beta blockers

Endoscopic therapy

Endoscopic therapy+ PSE

Somatostatin+endoscopic therapy

Somatostatin+endoscopic therapy+PSE

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 8, 2016
Last Updated
September 8, 2021
Sponsor
Yanjing Gao
Collaborators
Shandong Provincial Hospital, Jinan Military General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02778425
Brief Title
The Treatment of Hepatocirrhosis and Portal Hypertension
Official Title
Partial Splenic Embolization Combined With Endoscopic Therapies and NSBB Decreases the Variceal Rebleeding Rate in Cirrhosis Patients With Hypersplenism: a Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yanjing Gao
Collaborators
Shandong Provincial Hospital, Jinan Military General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Cirrhosis, Portal Hypertension
Keywords
Partial splenic embolization, Hypersplenism, Thrombocytopenia, Portal hypertension, Gastroesophageal varices, Secondary prophylaxis, Endoscopic variceal ligation, Non-selective beta-blocker

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Secondary prevention-1
Arm Type
Experimental
Arm Description
Endoscopic therapy+ beta blockers
Arm Title
Secondary prevention-2
Arm Type
Experimental
Arm Description
Endoscopic therapy+ PSE+beta blockers
Arm Title
Primary prevention-1
Arm Type
Experimental
Arm Description
Beta blockers
Arm Title
Primary prevention-2
Arm Type
Experimental
Arm Description
Endoscopic therapy
Arm Title
Primary prevention-3
Arm Type
Experimental
Arm Description
Endoscopic therapy+ PSE
Arm Title
Acute bleeding-1
Arm Type
Experimental
Arm Description
Somatostatin+endoscopic therapy
Arm Title
Acute bleeding-2
Arm Type
Experimental
Arm Description
Somatostatin+endoscopic therapy+PSE
Intervention Type
Procedure
Intervention Name(s)
Endoscopic therapy+ beta blockers
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic therapy+ PSE+beta blockers
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
beta blockers
Intervention Description
A standard dose of NSBB (propranolol) was applied to the primary prevention patients according to the Baveno VI recommendations if there were no contraindications.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic therapy
Intervention Description
Endoscopic variceal ligation (EVL) is for the primary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).
Intervention Type
Procedure
Intervention Name(s)
Endoscopic therapy+ PSE
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Somatostatin+Endoscopic therapy
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Somatostatin+Endoscopic therapy+PSE
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary endpoint was variceal rebleeding
Description
The rebleeding rate of the varices in the EP group will compared to that in the E group during the follow up.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
The secondary endpoints were severe variceal recurrence and mortality during the 2-year follow-up
Description
The recurrence rate of the varices in the EP group will compared to that in the E group during the follow up.
Time Frame
2 years
Title
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.
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanjing Gao Yanjing Gao, PhD.MD
Organizational Affiliation
Qilu Hospital,Shandong Universty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology,Qilu Hospital,Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All the individual participant data (IPD) available to other researchers.
IPD Sharing Time Frame
2021.1
IPD Sharing Access Criteria
Open Access
IPD Sharing URL
https://doi.org/10.1007/s12072-021-10155-0
Citations:
PubMed Identifier
33638769
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.
Results Reference
derived

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The Treatment of Hepatocirrhosis and Portal Hypertension

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