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

Liver Cirrhosis Clinical Trial

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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05055713
• Other study ID #: 20200925-Qilu
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 25, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: Qilu Hospital of Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 368
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Fibrosis
• Hypersplenism
• Liver Cirrhosis

Intervention

Procedure:
• Endoscopic therapy+ beta blockers
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.
• Endoscopic therapy+ PSE+beta blockers
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.
• Endoscopic therapy
Endoscopic variceal ligation (EVL) is for the secondary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).
• Endoscopic therapy+ PSE
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.
• Endoscopic therapy+Somatostatin
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).
• Endoscopic therapy+PSE+Somatostatin
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.

Locations

Country	Name	City	State
China	Qilu Hospital , Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rebleeding	the rate of rebleeding after endoscopic therapy	2 to 30days