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

Sponsor

Qilu Hospital of Shandong University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05055713

Collaborator

(none)

368

Enrollment

Location

Arms

27.2

Anticipated Duration (Months)

13.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cirrhosis Esophageal and Gastric Varices Hypersplenism	Procedure: Endoscopic therapy+ beta blockers Procedure: Endoscopic therapy+ PSE+beta blockers Procedure: Endoscopic therapy Procedure: Endoscopic therapy+ PSE Procedure: Endoscopic therapy+Somatostatin Procedure: Endoscopic therapy+PSE+Somatostatin	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

368 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Sep 25, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Secondary prevention-1 Endoscopic therapy+ beta blockers	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.
Experimental: Secondary prevention-2 Endoscopic therapy+ PSE+beta blockers	Procedure: 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.
Experimental: Primary prevention-1 Endoscopic therapy	Procedure: Endoscopic therapy Endoscopic variceal ligation (EVL) is for the secondary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).
Experimental: Primary prevention-2 Endoscopic therapy+ PSE	Procedure: 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.
Experimental: Acute bleeding-1 Endoscopic therapy+somatostatin	Procedure: 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).
Experimental: Acute bleeding-2 Endoscopic therapy+PSE+somatostatin	Procedure: 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.

Outcome Measures

Primary Outcome Measures

rebleeding [2 to 30days]
the rate of rebleeding after endoscopic therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.