NCT05055713

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
368

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 24, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 2, 2022

Status Verified

September 1, 2021

Enrollment Period

2.3 years

First QC Date

September 16, 2021

Last Update Submit

February 14, 2022

Conditions

Liver CirrhosisEsophageal and Gastric VaricesHypersplenism

Keywords

Esophageal and Gastric VaricesHypersplenismRebleedingPartial splenic artery embolizationEndoscopic Variceal Ligation

Outcome Measures

Primary Outcomes (1)

  • rebleeding

    the rate of rebleeding after endoscopic therapy

    2 to 30days

Study Arms (6)

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

Endoscopic therapy

Procedure: Endoscopic therapy

Primary prevention-2

EXPERIMENTAL

Endoscopic therapy+ PSE

Procedure: Endoscopic therapy+ PSE

Acute bleeding-1

EXPERIMENTAL

Endoscopic therapy+somatostatin

Procedure: Endoscopic therapy+Somatostatin

Acute bleeding-2

EXPERIMENTAL

Endoscopic therapy+PSE+somatostatin

Procedure: Endoscopic therapy+PSE+Somatostatin

Interventions

Endoscopic therapy+ beta blockersPROCEDURE

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.

Secondary prevention-1
Endoscopic therapy+ PSE+beta blockersPROCEDURE

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.

Secondary prevention-2
Endoscopic therapyPROCEDURE

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

Primary prevention-1
Endoscopic therapy+ PSEPROCEDURE

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.

Primary prevention-2
Endoscopic therapy+SomatostatinPROCEDURE

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
Endoscopic therapy+PSE+SomatostatinPROCEDURE

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

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.
  • Primary prevention:
  • 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).
  • Previous therapy (splenectomy, PSE, EVL, tissue adhesive injection, or usage of (NSBB) to prevent rebleeding
  • Bleeding from isolated gastric or ectopic varices
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital , Shandong University

Jinan, Shandong, China

Location

MeSH Terms

Conditions

Liver CirrhosisEsophageal and Gastric VaricesHypersplenism

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsEsophageal DiseasesGastrointestinal DiseasesHypertension, PortalSplenic DiseasesLymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Yanjing Gao, PhD.MD

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2021

First Posted

September 24, 2021

Study Start

September 25, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

March 2, 2022

Record last verified: 2021-09

Locations

CN(1)