Hepatic CirrhosisNCT02778425
The Treatment of Hepatocirrhosis and Portal Hypertension
A study testing Endoscopic therapy+ beta blockers, Endoscopic therapy+ PSE+beta blockers and beta blockers in people with Hepatic Cirrhosis and Portal Hypertension, run by Yanjing Gao at 1 site in China.
Trial summary
This study compare the efficiency of partial splenic embolization +endoscopical therapy with endoscopical therapy alone in gastroesophageal variceal haemorrhage accompanied with splenomegaly or hypersplenism of hepatocirrhosis and portal hypertension treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatic Cirrhosis, Portal Hypertension
- What is being tested?
- Endoscopic therapy+ beta blockers, Endoscopic therapy+ PSE+beta blockers and beta blockers
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- Feb 2016to Jan 2020
- 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).
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
- Pregnancy and lactation
- Inability to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology,Qilu Hospital,Shandong University
Jinan, Shandong, 250012
About this study
Official title: Partial Splenic Embolization Combined with Endoscopic Therapies and NSBB Decreases the Variceal Rebleeding Rate and Increases Recompensation Rate in Cirrhosis Patients with Hypersplenism: a Multicenter Randomized Controlled Trial
This study compare the efficiency of partial splenic embolization +endoscopical therapy with endoscopical therapy alone in gastroesophageal variceal haemorrhage accompanied with splenomegaly or hypersplenism of hepatocirrhosis and portal hypertension treatment.
Read the detailed description
Endoscopic therapy is the mature treatment of gastroesophageal variceal haemorrhage and PSE is an effective method for treatment of the hypersplenism and portal hypertension. Existing researches show that endoscopic therapy + PSE is more effective than endoscopic therapy alone in prevention of esophageal varices bleeding recurrence in the patients with liver cirrhosis. However, there is few articles which proved long-term effectiveness of endoscopic therapy + PSE, it needs further research on this issue. This study compares the efficiency of partial splenic embolization +endoscopic therapy with endoscopic therapy alone in the treatment of gastroesophageal variceal haemorrhage accompanied with splenomegaly or hypersplenism in the patients with hepatocirrhosis and portal hypertension.
- Conditions
- Hepatic Cirrhosis, Portal Hypertension
- Being tested
- Endoscopic therapy+ beta blockers, Endoscopic therapy+ PSE+beta blockers, beta blockers, Endoscopic therapy, Endoscopic therapy+ PSE
- Keywords
- Partial splenic embolization, Hypersplenism, Thrombocytopenia, Portal hypertension, Gastroesophageal varices, Secondary prophylaxis, Endoscopic variceal ligation, Non-selective beta-blocker, hepatic recompensation
- Medical subject headings
- Liver Cirrhosis, Hypertension, Portal, Hypersplenism, Thrombocytopenia
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 (propranolol) 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 (propranolol) 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.
beta blockersProcedure or surgery
A standard dose of NSBB (propranolol) was applied to the primary prevention patients according to the Baveno VI recommendations if there were no contraindications.
Endoscopic therapyProcedure or surgery
Endoscopic variceal ligation (EVL) is for the primary 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 primary 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.
Somatostatin+Endoscopic therapyProcedure 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).
Somatostatin+Endoscopic therapy+PSEProcedure 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 | Beta blockers Receives: Procedure: beta blockers |
| Primary prevention-2 | Experimental | Endoscopic therapy Receives: Procedure: Endoscopic therapy |
| Primary prevention-3 | Experimental | Endoscopic therapy+ PSE Receives: Procedure: Endoscopic therapy+ PSE |
| Acute bleeding-1 | Experimental | Somatostatin+endoscopic therapy Receives: Procedure: Somatostatin+Endoscopic therapy |
| Acute bleeding-2 | Experimental | Somatostatin+endoscopic therapy+PSE Receives: Procedure: Somatostatin+Endoscopic therapy+PSE |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint was variceal rebleeding
The rebleeding rate of the varices in the EP group will compared to that in the E group during the follow up.
Measured: 2 years
The primary outcome was the hepatic recompensation rate based on Baveno VII criteria after 1-year follow-up.
The hepatic recompensation rate based on Baveno VII criteria in the EP group will compared to that in the E group during the follow-up. Hepatic recompensation is a comprehensive assessment index defined as meeting all of the following criteria simultaneously: (1)Etiological Control: Removal/suppression/cure of the primary cause of cirrhosis (e.g., hepatitis C virus elimination, sustained suppression of hepatitis B virus, and sustained abstinence from alcohol in alcoholic cirrhosis); (2)Symptomatic Resolution: Regression of ascites (discontinuation of diuretics), remission of hepatic encephalopathy (discontinuation of lactulose/rifaximin), and absence of recurrent variceal bleeding (for at least 12 months); (3)Improvement in Liver Function: Stable improvement in liver function tests (albumin, INR, bilirubin).
Assessed via lab tests (HCV RNA, HBV DNA, albumin, INR, bilirubin) and clinical evaluation (ascites, encephalopathy, endoscopy). Reported as binary (Yes/No).
Measured: 2 years
Secondary outcomes (3)
The secondary endpoints were severe variceal recurrence and mortality during the 2-year follow-up
The recurrence rate of the varices in the EP group will compared to that in the E group during the follow up.
Measured: 2 years
Changes of the peripheral blood cell counts including white blood cell, red blood cell, and platelate counts in both group during 2-years follow up.
The physiological parameters including white blood cell (*10^9/L), red blood cell (*10^12/L) and platelte(*10^12/L) will compared between the two groups.
Measured: 2 years
The secondary endpoints were changes in Child-Pugh Score, MELD Score, and Physiological Parameters during the follow-up.
Changes in liver function (Child-Pugh score, MELD score) and physiological parameters (white blood cell count [*10^9/L], red blood cell count [*10^12/L], platelet count [*10^12/L], hemoglobin [g/dL], and coagulation parameters) will be assessed and compared during the 1-year follow-up between the two groups.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2019
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatic CirrhosisStudies 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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yanjing Gao
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Provincial Hospital, Jinan Military General Hospital
- Responsible party
- Sponsor-investigator, Yanjing Gao, Qilu Hospital of Shandong University
- Investigators
- Yanjing Gao Yanjing Gao, PhD.MD, Principal investigator, Qilu Hospital,Shandong Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778425
- Sponsor's protocol ID
- 201602-QILU
- Status last verified
- Sep 2021
- First submitted
- 8 May 2016
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: All the individual participant data (IPD) available to other researchers.
Publications
Wei M, Chen Y, Wang M, Li J, Zeng Y, Sun X, Zhang A, Liu X, Zhou T, Gao Y. Partial splenic embolization combined with endoscopic therapies and vasoconstrictive drugs reduces rebleeding in cirrhosis patients with acute variceal bleeding and hypersplenism: a multicenter randomized controlled trial. J Gastroenterol. 2023 Nov;58(11):1144-1153. doi: 10.1007/s00535-023-02027-1. Epub 2023 Jul 24.
PubMed 37486372Sun X, Zhang A, Zhou T, Wang M, Chen Y, Zhou T, Chen X, Xiu A, Peng Z, Cheng B, Liu X, Gao Y. Partial splenic embolization combined with endoscopic therapies and NSBB decreases the variceal rebleeding rate in cirrhosis patients with hypersplenism: a multicenter randomized controlled trial. Hepatol Int. 2021 Jun;15(3):741-752. doi: 10.1007/s12072-021-10155-0. Epub 2021 Feb 27.
PubMed 33638769
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Splenic Embolization Combined with Endoscopic Therapies and NSBB Decreases the Variceal Rebleeding Rate and Increases Recompensation Rate in Cirrhosis Patients with Hypersplenism: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02778425
- Acronym / sponsor ID
- 201602-QILU
- Conditions
- Hepatic Cirrhosis, Portal Hypertension
- Keywords
- Partial splenic embolization, Hypersplenism, Thrombocytopenia, Portal hypertension, Gastroesophageal varices, Secondary prophylaxis, Endoscopic variceal ligation, Non-selective beta-blocker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Yanjing GaoUniversity, hospital or other
- Collaborators
- Shandong Provincial Hospital, Jinan Military General Hospital
- Study start
- Feb 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 19 May 2016 (estimated)
- 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 compare the efficiency of partial splenic embolization +endoscopical therapy with endoscopical therapy alone in gastroesophageal variceal haemorrhage accompanied with splenomegaly or hypersplenism of hepatocirrhosis and portal hypertension treatment.
Detailed description
Endoscopic therapy is the mature treatment of gastroesophageal variceal haemorrhage and PSE is an effective method for treatment of the hypersplenism and portal hypertension. Existing researches show that endoscopic therapy + PSE is more effective than endoscopic therapy alone in prevention of esophageal varices bleeding recurrence in the patients with liver cirrhosis. However, there is few articles which proved long-term effectiveness of endoscopic therapy + PSE, it needs further research on this issue. This study compares the efficiency of partial splenic embolization +endoscopic therapy with endoscopic therapy alone in the treatment of gastroesophageal variceal haemorrhage accompanied with splenomegaly or hypersplenism in the patients with hepatocirrhosis and portal hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 7
| 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: beta blockersBeta blockers |
| Primary prevention-2 | Experimental | Procedure: Endoscopic therapyEndoscopic therapy |
| Primary prevention-3 | Experimental | Procedure: Endoscopic therapy+ PSEEndoscopic therapy+ PSE |
| Acute bleeding-1 | Experimental | Procedure: Somatostatin+Endoscopic therapySomatostatin+endoscopic therapy |
| Acute bleeding-2 | Experimental | Procedure: Somatostatin+Endoscopic therapy+PSESomatostatin+endoscopic therapy+PSE |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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).
Key exclusion criteria (8 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 (propranolol) 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 (propranolol) 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 |
| beta blockersA standard dose of NSBB (propranolol) was applied to the primary prevention patients according to the Baveno VI recommendations if there were no contraindications. | Procedure or surgery | Primary prevention-1 |
| Endoscopic therapyEndoscopic variceal ligation (EVL) is for the primary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV). | Procedure or surgery | Primary prevention-2 |
| Endoscopic therapy+ PSEEndoscopic variceal ligation (EVL) is for the primary 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-3 |
| Somatostatin+Endoscopic therapyThe 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 |
| Somatostatin+Endoscopic therapy+PSEThe 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
The primary endpoint was variceal rebleeding
Time frame: 2 years
The rebleeding rate of the varices in the EP group will compared to that in the E group during the follow up.
The primary outcome was the hepatic recompensation rate based on Baveno VII criteria after 1-year follow-up.
Time frame: 2 years
The hepatic recompensation rate based on Baveno VII criteria in the EP group will compared to that in the E group during the follow-up. Hepatic recompensation is a comprehensive assessment index defined as meeting all of the following criteria simultaneously: (1)Etiological Control: Removal/suppression/cure of the primary cause of cirrhosis (e.g., hepatitis C virus elimination, sustained suppression of hepatitis B virus, and sustained abstinence from alcohol in alcoholic cirrhosis); (2)Symptomatic Resolution: Regression of ascites (discontinuation of diuretics), remission of hepatic encephalopathy (discontinuation of lactulose/rifaximin), and absence of recurrent variceal bleeding (for at least 12 months); (3)Improvement in Liver Function: Stable improvement in liver function tests (albumin, INR, bilirubin). Assessed via lab tests (HCV RNA, HBV DNA, albumin, INR, bilirubin) and clinical evaluation (ascites, encephalopathy, endoscopy). Reported as binary (Yes/No).
3 secondary outcomes
The secondary endpoints were severe variceal recurrence and mortality during the 2-year follow-up
Time frame: 2 years
Changes of the peripheral blood cell counts including white blood cell, red blood cell, and platelate counts in both group during 2-years follow up.
Time frame: 2 years
The secondary endpoints were changes in Child-Pugh Score, MELD Score, and Physiological Parameters during the follow-up.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Derived from this study: PubMed 37486372Wei M, Chen Y, Wang M, Li J, Zeng Y, Sun X, Zhang A, Liu X, Zhou T, Gao Y. Partial splenic embolization combined with endoscopic therapies and vasoconstrictive drugs reduces rebleeding in cirrhosis patients with acute variceal bleeding and hypersplenism: a multicenter randomized controlled trial. J Gastroenterol. 2023 Nov;58(11):1144-1153. doi: 10.1007/s00535-023-02027-1. Epub 2023 Jul 24.
- Derived from this study: PubMed 33638769Sun X, Zhang A, Zhou T, Wang M, Chen Y, Zhou T, Chen X, Xiu A, Peng Z, Cheng B, Liu X, Gao Y. Partial splenic embolization combined with endoscopic therapies and NSBB decreases the variceal rebleeding rate in cirrhosis patients with hypersplenism: a multicenter randomized controlled trial. Hepatol Int. 2021 Jun;15(3):741-752. doi: 10.1007/s12072-021-10155-0. Epub 2021 Feb 27.
- Individual participant dataSharing planned: Yes. All the individual participant data (IPD) available to other researchers.
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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 Yanjing Gao, PhD.MD principal investigator
Qilu Hospital,Shandong Universty
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 beta blockers in people with Hepatic Cirrhosis and Portal Hypertension, run by Yanjing Gao 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 14 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary endpoint was variceal rebleeding (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02778425, which also lists 2 linked publications.
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 14 Feb 2025.