Gastroesophageal VaricesNCT04692805
EUS-guided PSE in Combination With EUS-guided Treatment of Varices for Patients With Portal Hypertension
A study testing coils and cyanoacrylate glue in people with Gastroesophageal Varices and Hypersplenism, run by Tongji Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastroesophageal Varices, Hypersplenism, Portal Hypertension
- What is being tested?
- coils and cyanoacrylate glue
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2021to 5 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Division of Gastroenterology, Department of Internal Medicine at Tongji Hospital, , Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Qian Chen, Ph.D, M.D, +86 13697322504, chenqian201579@yahoo.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastroesophageal Varices, Hypersplenism, Portal Hypertension
- Being tested
- coils, cyanoacrylate glue
- Medical subject headings
- Hypersplenism, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coilsDevice
EUS-guided injection of coils
cyanoacrylate glueDrug
EUS-guided injection of cyanoacrylate glue
| Study group | Role | What they receive |
|---|---|---|
| EUS-guided treatment of varices | Experimental | 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). Receives: Device: coils; Drug: cyanoacrylate glue |
| EUS-guided partial splenic embolization + EUS-guided treatment of varices | Experimental | 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). Receives: Device: coils; Drug: cyanoacrylate glue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of EUS-guided treatment for varices
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.
Measured: 6 months
Secondary outcomes (2)
Safety of EUS-guided combination therapy in cirrhotic patients with gastroesophageal varices and hypersplenism
Safety will be determined by measure of incidence of adverse events related to EUS-guided procedure within and after 30 days of the procedure.
Measured: 6 months
Efficacy of EUS-guided partial splenic embolization
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start5 Jan 2021
- Primary completion5 Jul 2021 (estimated)
- Study completion5 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal VaricesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian Chen, Tongji Hospital
- Investigators
- Qian Chen, Ph.D, M.D, Principal investigator, Tongji HospitalZhen-gang Zhang, Ph.D, M.D, Study chair, Tongji HospitalBin Cheng, Ph.D, M.D, Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692805
- Sponsor's protocol ID
- S320
- Status last verified
- Jan 2021
- First submitted
- 29 Dec 2020
- Last updated
- 8 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS-guided Partial Splenic Embolization in Combination With EUS-guided Treatment of Varices for Patients With Portal Hypertension
- ClinicalTrials.gov ID
- NCT04692805
- Acronym / sponsor ID
- S320
- Conditions
- Gastroesophageal Varices, Hypersplenism, Portal Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 5 Jul 2021 (estimated)
- Study completion
- 5 Jan 2022 (estimated)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS-guided treatment of varices | Experimental | Device: coils, Drug: cyanoacrylate glueProcedure: 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). |
| EUS-guided partial splenic embolization + EUS-guided treatment of varices | Experimental | Device: coils, Drug: cyanoacrylate glueProcedure: 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coilsEUS-guided injection of coils | Device | EUS-guided partial splenic embolization + EUS-guided treatment of varices, EUS-guided treatment of varices |
| cyanoacrylate glueEUS-guided injection of cyanoacrylate glue | Drug | EUS-guided partial splenic embolization + EUS-guided treatment of varices, EUS-guided treatment of varices |
Primary outcome
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.
2 secondary outcomes
Safety of EUS-guided combination therapy in cirrhotic patients with gastroesophageal varices and hypersplenism
Time frame: 6 months
Efficacy of EUS-guided partial splenic embolization
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qian Chen, Ph.D, M.D principal investigator
Tongji Hospital
Zhen-gang Zhang, Ph.D, M.D study chair
Tongji Hospital
Bin Cheng, Ph.D, M.D study chair
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coils and cyanoacrylate glue in people with Gastroesophageal Varices and Hypersplenism, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qian Chen, Ph.D M.D (+86 13697322504, chenqian201579@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of EUS-guided treatment for varices (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021.