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Gastric variceal obturation is the current endoscopic therapy of choice for gastric variceal bleeding but is associated with a high rebleeding rate. Carvedilol is a potent non-selective β-blocker. The role of carvedilol in the prevention of recurrent gastric variceal bleeding is not studied. This study aimed at evaluating the efficacy of carvedilol as an adjunct to gastric variceal obturation in the secondary prophylaxis of gastric variceal bleeding.
Gastric variceal bleeding is a lethal complication of portal hypertension. The rebleeding rate ranged between 30% to 50% in patients after initial hemostasis. Endoscopic cyanoacrylate injection is currently the choice of endoscopic therapy of acute gastric variceal bleeding and prevention of recurrent bleeding. However, the rebleeding rate is still high in the patients undergoing repeated endoscopic cyanoacrylate injection.
Non-selective β-blockers are frequently used for the secondary prophylaxis of variceal bleeding. In the case of esophageal varices, combination of non-selective β-blockers and endoscopic therapy significantly lowers the rebleeding rate compared with endoscopic therapy alone. However, propranolol failed to decrease the rebleeding rate as an adjunct to endoscopic cyanoacrylate injection and was associated with a higher incidence of adverse effects in gastric variceal bleeding patients. A more potent non-selective β-blocker than propranolol might further decrease portal pressure and decrease the rebleeding rate.
Carvedilol is a potent non-selective β-blocker with both beta and alpha-1 blocker effect. It significantly lowers portal pressure even in propranolol non-responders. However, it is unclear weather carvedilol will play a role in the prevention of recurrent gastric variceal bleeding. The investigators conducted a randomized controlled trial to compare the efficacy of carvedilol combined with endoscopic cyanoacrylate injection with endoscopic cyanoacrylate injection alone in secondary prophylaxis of gastric variceal bleeding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyanoacrylate injection plus carvedilol | Experimental | The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose. |
|
| Cyanoacrylate injection | Active Comparator | The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carvedilol | Drug | Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure >90 mm Hg. |
| Measure | Description | Time Frame |
|---|---|---|
| Rebleeding From Gastric Varices | Rebleeding from gastric varices during the follow-up period | Within 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| All Upper Gastrointestinal Bleeding | All upper gastrointestinal bleeding during the follow-up period | Within 6 years |
| All Cause Mortality or Liver Transplantation | All cause mortality or liver transplantation during the study period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wen-Chi Chen, MD | Kaohsiung Veterans General Hospital. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Veterans General Hospital | Kaohsiung City | 813 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30772583 | Derived | Chen WC, Hsin IF, Chen PH, Hsu PI, Wang YP, Cheng JS, Lin HS, Hou MC, Lee FY. Addition of Carvedilol to Gastric Variceal Obturation Does Not Decrease Recurrence of Gastric Variceal Bleeding in Patients With Cirrhosis. Clin Gastroenterol Hepatol. 2019 Oct;17(11):2356-2363.e2. doi: 10.1016/j.cgh.2019.02.021. Epub 2019 Feb 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cyanoacrylate Injection Plus Carvedilol | The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose. carvedilol: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure >90 mm Hg. cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. |
| FG001 | Cyanoacrylate Injection | The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cyanoacrylate Injection Plus Carvedilol | The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose. carvedilol: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure >90 mm Hg. cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rebleeding From Gastric Varices | Rebleeding from gastric varices during the follow-up period | Posted | Count of Participants | Participants | Within 6 years |
|
6 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cyanoacrylate Injection Plus Carvedilol | The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose. carvedilol: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure >90 mm Hg. cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dizziness | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Wen-Chi Chen | Kaohsiung Veterans General Hospital | 886-7-3422121 | 2139 | wcchen@vghks.gov.tw |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 12, 2011 | Jul 27, 2017 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D004932 | Esophageal and Gastric Varices |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006975 | Hypertension, Portal |
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| ID | Term |
|---|---|
| D000077261 | Carvedilol |
| D003487 | Cyanoacrylates |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| cyanoacrylate | Drug | The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. |
|
| Within 6 years |
| All Adverse Effects | All adverse effects during the study period | Within 6 years |
| BG001 | Cyanoacrylate Injection | The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | Cyanoacrylate Injection | The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. |
|
|
| Secondary | All Upper Gastrointestinal Bleeding | All upper gastrointestinal bleeding during the follow-up period | Posted | Count of Participants | Participants | Within 6 years |
|
|
|
| Secondary | All Cause Mortality or Liver Transplantation | All cause mortality or liver transplantation during the study period | Posted | Count of Participants | Participants | Within 6 years |
|
|
|
| Secondary | All Adverse Effects | All adverse effects during the study period | Posted | Count of Participants | Participants | Within 6 years |
|
|
|
| 12 |
| 60 |
| 0 |
| 60 |
| 32 |
| 60 |
| EG001 | Cyanoacrylate Injection | The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. | 19 | 61 | 0 | 61 | 9 | 61 |
| weakness | General disorders | Systematic Assessment |
|
| hypotension | General disorders | Systematic Assessment |
|
| fatigue | General disorders | Systematic Assessment |
|
| abdominal pain | General disorders | Systematic Assessment |
|
| insomnia | General disorders | Systematic Assessment |
|
| chronic cough | General disorders | Systematic Assessment |
|
| dyspnea on exertion | General disorders | Systematic Assessment |
|
| poor gastric ulcer healing | Gastrointestinal disorders | Systematic Assessment |
|
| dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| recurrent bacteremia | Infections and infestations | Systematic Assessment |
|
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D008107 | Liver Diseases |
| D020005 |
| Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000179 | Acrylates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009570 | Nitriles |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D014014 | Tissue Adhesives |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |