EUS-guided PSE in Combination With EUS-guided Treatment of Varices for Patients With Portal Hypertension

January 7, 2021 updated by: Qian Chen, Tongji Hospital

EUS-guided Partial Splenic Embolization in Combination With EUS-guided Treatment of Varices for Patients With Portal Hypertension

This study aims to evaluate the efficiency of EUS-guided combination therapy (EUS-guided PSE + EUS-guided treatment of varices) to EUS-guided treatment of varices alone in cirrhotic patients with portal hypertension who have developed gastroesophageal variceal hemorrhage and accompanied with hypersplenism.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Partial splenic embolization (PSE) was developed in the purpose of managing two common complications of portal hypertension including variceal bleeding and hypersplenism. The procedure is normally performed by clinicians engaged in interventional radiology via a transcatheter embolization method as the successful embolization of the selected splenic arteries results in devascularization of a focal lesion followed by splenic infarction and subsequently reducing the splenic contribution to the portal blood flow. Our previous case study suggests implanting coil in a branch of splenic artery under the endoscopic ultrasound (EUS) -guidance followed by the glue injection was an alternative PSE procedure to control hypersplenism. Recent advance has also heightened the therapeutic aspect of EUS in managing varices. We have established the novel approach to manage varices and hypersplenism at the same time by combining EUS-guided PSE and EUS-guided treatment of varices. This study aims to evaluate the efficiency of EUS-guided combination therapy (EUS-guided PSE + EUS-guided treatment of varices) to EUS-guided treatment of varices alone in cirrhotic patients with portal hypertension who have developed gastroesophageal variceal hemorrhage and accompanied with hypersplenism.

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • The Division of Gastroenterology, Department of Internal Medicine at Tongji Hospital, , Tongji Medical College, Huazhong University of Science and Technology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At the risk of gastroesophageal variceal hemorrhage; Acute gastroesophageal variceal hemorrhage; Hematemesis and/or melena resulted from gastroesophageal variceal hemorrhage of liver cirrhosis in the past.
  • Hypersplenism is indicated by either abdominal ultrasound or CT image showing splenic enlargement or splenomegaly and CBC test showing deficiency of one or more blood cell lines.
  • Consent form must be signed by patients or their guardians before entering the test.

Exclusion Criteria:

  • History of liver surgery or spleen surgery and liver cancer
  • Coagulopathy (INR > 1.5) or having been taken oral anticoagulation agents such as aspirin, warfarin, etc. in the past week.
  • Existence of gastrointestinal endoscopic therapy contraindication; Hemorrhagic shock has not be corrected; Hepatic encephalopathy; Moderate to severe ascites, Poor liver function (Child - Pugh class C).
  • Severe cardiorespiratory dysfunction, including sinus bradycardia, bronchial asthma, chronic obstructive pulmonary disease, heart failure, and atrioventricular block
  • Pregnant women and nursing mothers.
  • Absence of informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EUS-guided treatment of varices

Procedure: EUS-guided injection of coils with cyanoacrylate glue (CYA) and sclerosing agent.

First CT scan will be ordered to determine the patient having esophageal and gastric varices and splenomegaly.

Complete blood count (CBC) will be ordered to confirm the deficiency of one or more blood cell lines.

A standard diagnostic upper endoscopy will be performed in order to classify the varices according to the classification of Sarin and Kumar. Only GOV II and IGV I varices will be included. Once the patient considered as a candidate will be treated with Coils plus CYA and sclerosing agent (Group A).
Device: coils
EUS-guided injection of coils
Drug: cyanoacrylate glue
EUS-guided injection of cyanoacrylate glue
Experimental: EUS-guided partial splenic embolization + EUS-guided treatment of varices

Procedure: EUS-guided partial splenic embolization + EUS-guided treatment of varices First CT scan will be ordered to determine the patient having esophageal and gastric varices and splenomegaly.

Complete blood count (CBC) will be ordered to confirm the deficiency of one or more blood cell lines.

A standard diagnostic upper endoscopy will be performed in order to classify the varices according to the classification of Sarin and Kumar. Only GOV II and IGV I varices will be included. Once the patient considered as a candidate will be treated with coils plus CYA and sclerosing agent.

At the same procedure, a branch of splenic artery will be identified by EUS and implanted with coils plus CYA (Group B).
Device: coils
EUS-guided injection of coils
Drug: cyanoacrylate glue
EUS-guided injection of cyanoacrylate glue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of EUS-guided treatment for varices
Time Frame: 6 months
Efficacy will be determined by recording recurrent events of hematemesis and/or melena after the EUS-guided procedure. Further confirmation of gastroesophageal variceal hemorrhage will be evaluated by upper gastric endoscopy and lab tests.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of EUS-guided combination therapy in cirrhotic patients with gastroesophageal varices and hypersplenism
Time Frame: 6 months
Safety will be determined by measure of incidence of adverse events related to EUS-guided procedure within and after 30 days of the procedure.
6 months
Efficacy of EUS-guided partial splenic embolization
Time Frame: 6 months
Efficacy will be measured by rates of successful technique among all performance. Technical success is defined as complete obliteration of the branch of splenic artery and absence of Doppler flow on EUS, and functional success, defined as improved hematologic parameters and the detectable splenic infarction by CT.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Investigators

  • Principal Investigator: Qian Chen, Ph.D, M.D, Tongji Hospital
  • Study Chair: Zhen-gang Zhang, Ph.D, M.D, Tongji Hospital
  • Study Chair: Bin Cheng, Ph.D, M.D, Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2021

Primary Completion (Anticipated)

July 5, 2021

Study Completion (Anticipated)

January 5, 2022

Study Registration Dates

First Submitted

December 29, 2020

First Submitted That Met QC Criteria

December 29, 2020

First Posted (Actual)

January 5, 2021

Study Record Updates

Last Update Posted (Actual)

January 8, 2021

Last Update Submitted That Met QC Criteria

January 7, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S320

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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