Liver CirrhosisNCT05055713
A Randomized Controlled Study on the Treatment of Cirrhosis Combined With Hypersplenism
A study testing Endoscopic therapy+ beta blockers, Endoscopic therapy+ PSE+beta blockers and Endoscopic therapy in people with Liver Cirrhosis and Esophageal and Gastric Varices, run by Qilu Hospital of Shandong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis, Esophageal and Gastric Varices, Hypersplenism
- What is being tested?
- Endoscopic therapy+ beta blockers, Endoscopic therapy+ PSE+beta blockers and Endoscopic therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2020to 31 Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- Patients aged between 18 and 75 years
- Moderate to severe esophageal (and/or) gastric varices
Show all 12Show fewer
- 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).
- 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).
Who cannot join
- 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
Show all 26Show fewer
- Pregnancy and lactation
- Inability to sign the informed consent.
- Primary prevention:
- 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:
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Being tested
- Endoscopic therapy+ beta blockers, Endoscopic therapy+ PSE+beta blockers, Endoscopic therapy, Endoscopic therapy+ PSE, Endoscopic therapy+Somatostatin
- Keywords
- Esophageal and Gastric Varices, Hypersplenism, Rebleeding, Partial splenic artery embolization, Endoscopic Variceal Ligation
- Medical subject headings
- Liver Cirrhosis, Esophageal and Gastric Varices, Hypersplenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic therapy+ beta blockersProcedure or surgery
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 blockersProcedure or surgery
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 therapyProcedure or surgery
Endoscopic variceal ligation (EVL) is for the secondary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).
Endoscopic therapy+ PSEProcedure or surgery
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+SomatostatinProcedure or surgery
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+SomatostatinProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Secondary prevention-1 | Experimental | Endoscopic therapy+ beta blockers Receives: Procedure: Endoscopic therapy+ beta blockers |
| Secondary prevention-2 | Experimental | Endoscopic therapy+ PSE+beta blockers Receives: Procedure: Endoscopic therapy+ PSE+beta blockers |
| Primary prevention-1 | Experimental | Endoscopic therapy Receives: Procedure: Endoscopic therapy |
| Primary prevention-2 | Experimental | Endoscopic therapy+ PSE Receives: Procedure: Endoscopic therapy+ PSE |
| Acute bleeding-1 | Experimental | Endoscopic therapy+somatostatin Receives: Procedure: Endoscopic therapy+Somatostatin |
| Acute bleeding-2 | Experimental | Endoscopic therapy+PSE+somatostatin Receives: Procedure: Endoscopic therapy+PSE+Somatostatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
rebleeding
the rate of rebleeding after endoscopic therapy
Measured: 2 to 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start25 Sep 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yanjing Gao, PhD.MD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055713
- Sponsor's protocol ID
- 20200925-Qilu
- Status last verified
- Sep 2021
- First submitted
- 16 Sep 2021
- Last updated
- 2 Mar 2022
- 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 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05055713
- Acronym / sponsor ID
- 20200925-Qilu
- Keywords
- Esophageal and Gastric Varices, Hypersplenism, Rebleeding, Partial splenic artery embolization, Endoscopic Variceal Ligation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 24 Sep 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.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Secondary prevention-1 | Experimental | Procedure: Endoscopic therapy+ beta blockersEndoscopic therapy+ beta blockers |
| Secondary prevention-2 | Experimental | Procedure: Endoscopic therapy+ PSE+beta blockersEndoscopic therapy+ PSE+beta blockers |
| Primary prevention-1 | Experimental | Procedure: Endoscopic therapyEndoscopic therapy |
| Primary prevention-2 | Experimental | Procedure: Endoscopic therapy+ PSEEndoscopic therapy+ PSE |
| Acute bleeding-1 | Experimental | Procedure: Endoscopic therapy+SomatostatinEndoscopic therapy+somatostatin |
| Acute bleeding-2 | Experimental | Procedure: Endoscopic therapy+PSE+SomatostatinEndoscopic therapy+PSE+somatostatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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).
- Patients aged between 18 and 75 years
Key exclusion criteria (26 listed)
- 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
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 |
|---|---|---|
| Endoscopic therapy+ beta blockersEndoscopic 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. | Procedure or surgery | Secondary prevention-1 |
| Endoscopic therapy+ PSE+beta blockersEndoscopic 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. | Procedure or surgery | Secondary prevention-2 |
| Endoscopic therapyEndoscopic variceal ligation (EVL) is for the secondary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV). | Procedure or surgery | Primary prevention-1 |
| Endoscopic therapy+ PSEEndoscopic 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. | Procedure or surgery | Primary prevention-2 |
| Endoscopic therapy+SomatostatinThe 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). | Procedure or surgery | Acute bleeding-1 |
| Endoscopic therapy+PSE+SomatostatinThe 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. | Procedure or surgery | Acute bleeding-2 |
Primary outcome
rebleeding
Time frame: 2 to 30days
the rate of rebleeding after endoscopic therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
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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.
Yanjing Gao, PhD.MD principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic therapy+ beta blockers, Endoscopic therapy+ PSE+beta blockers and Endoscopic therapy in people with Liver Cirrhosis and Esophageal and Gastric Varices, run by Qilu Hospital of Shandong University 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 12 inclusion and 26 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 2 Mar 2022. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rebleeding (time frame: 2 to 30days). 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 2 Mar 2022.