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A Randomized Controlled Study on the Treatment of Cirrhosis Combined With Hypersplenism

Primary Purpose

Liver Cirrhosis, Esophageal and Gastric Varices, Hypersplenism

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Endoscopic therapy+ beta blockers
Endoscopic therapy+ PSE+beta blockers
Endoscopic therapy
Endoscopic therapy+ PSE
Endoscopic therapy+Somatostatin
Endoscopic therapy+PSE+Somatostatin
Sponsored by
Qilu Hospital of Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring Esophageal and Gastric Varices, Hypersplenism, Rebleeding, Partial splenic artery embolization, Endoscopic Variceal Ligation

Eligibility Criteria

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

Secondary prevention:

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 prevention:

Inclusion Criteria:

  • Patients aged between 18 and 75 years
  • Moderate to severe esophageal (and/or) gastric varices
  • 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.

Acute bleeding:

Inclusion Criteria:

  • Patients aged between 18 and 75 years
  • Acute esophageal (and/or) gastric varices rupture and bleed <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

  • Qilu Hospital , Shandong University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Secondary prevention-1

Secondary prevention-2

Primary prevention-1

Primary prevention-2

Acute bleeding-1

Acute bleeding-2

Arm Description

Endoscopic therapy+ beta blockers

Endoscopic therapy+ PSE+beta blockers

Endoscopic therapy

Endoscopic therapy+ PSE

Endoscopic therapy+somatostatin

Endoscopic therapy+PSE+somatostatin

Outcomes

Primary Outcome Measures

rebleeding
the rate of rebleeding after endoscopic therapy

Secondary Outcome Measures

Full Information

First Posted
September 16, 2021
Last Updated
February 14, 2022
Sponsor
Qilu Hospital of Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT05055713
Brief Title
A Randomized Controlled Study on the Treatment of Cirrhosis Combined With Hypersplenism
Official Title
The Effects of Endoscopy Combined With Partial Splenic Artery Embolization in the Treatment of Cirrhosis With Esophageal and Gastric Varices Complicated With Hyperplenism or Splenomegaly:A Randomized Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 25, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Hospital of Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study was to compare the effects of partial splenic artery embolization combined with endoscopic treatment and endoscopic treatment alone on portal hypertension in cirrhosis with hyperplenism or splenomegaly in esophageal and gastric varices.
Detailed Description
Although there have been many consensus opinions on the treatment of cirrhosis patients with esophageal and gastric variceal hemorrhage, there is no standard to follow for the treatment of cirrhosis patients with esophageal and gastric variceal hemorrhage combined with hypersplenism or splenomegalism, and studies show that the patients with cirrhosis combined with severe hypersplenism account for about 33%. It has been reported that partial splenic artery embolization is effective in the treatment of hypersplenism or splenomegaly caused by portal hypertension in liver cirrhosis, but for liver cirrhosis with esophageal and gastric varices hemorrhage in port or spleen large combined at the same time of endoscopic treatment should joint partial splenic artery embolization treatment remains controversial.Therefore, it is urgent to further study the effect of partial splenic artery embolization combined with endoscopic therapy on cirrhosis with esophageal and gastric variceal hemorrhage combined with hyperspleenism or splenomegaly.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Esophageal and Gastric Varices, Hypersplenism
Keywords
Esophageal and Gastric Varices, Hypersplenism, Rebleeding, Partial splenic artery embolization, Endoscopic Variceal Ligation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
368 (Anticipated)

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
Endoscopic therapy
Arm Title
Primary prevention-2
Arm Type
Experimental
Arm Description
Endoscopic therapy+ PSE
Arm Title
Acute bleeding-1
Arm Type
Experimental
Arm Description
Endoscopic therapy+somatostatin
Arm Title
Acute bleeding-2
Arm Type
Experimental
Arm Description
Endoscopic therapy+PSE+somatostatin
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 (carvedilol) 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 (carvedilol) 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)
Endoscopic therapy
Intervention Description
Endoscopic variceal ligation (EVL) is for the secondary 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 secondary 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)
Endoscopic therapy+Somatostatin
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)
Endoscopic therapy+PSE+Somatostatin
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
rebleeding
Description
the rate of rebleeding after endoscopic therapy
Time Frame
2 to 30days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Secondary prevention: 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 prevention: Inclusion Criteria: Patients aged between 18 and 75 years Moderate to severe esophageal (and/or) gastric varices 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. Acute bleeding: Inclusion Criteria: Patients aged between 18 and 75 years Acute esophageal (and/or) gastric varices rupture and bleed <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, PhD.MD
Organizational Affiliation
Qilu Hospital, Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qilu Hospital , Shandong University
City
Jinan
State/Province
Shandong
Country
China

12. IPD Sharing Statement

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A Randomized Controlled Study on the Treatment of Cirrhosis Combined With Hypersplenism

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