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This study is aimed at investigating the effect of PPIs on gastroesophageal varices in liver cirrhosis. Half of participants will receive PPI, while the other half will receive a placebo.
PPIs can inhibit parietal cell H+/K+-ATPase and reduce secretion of gastric acid. PPIs can promote platelet aggregation and stabilize the formation of fibrin thrombosis by maintaining the high pH environment in the stomach and inactivating pepsin. The effect of PPIs on ulcerative upper gastrointestinal bleeding was confirmed but it is not clear whether PPIs is applicable in esophagogastric variceal bleeding whose etiology and bleeding position are different from ulcerative upper gastrointestinal bleeding. There is lack of consensus and sufficient evidences to support to use PPIs in esophagogastric variceal bleeding in cirrhotic patients universally. Nevertheless, the use of PPIs in liver cirrhotic patients with gastroesophageal varices is common.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proton Pump Inhibitors | Experimental | Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment. |
|
| Placebo | Placebo Comparator | Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton Pump Inhibitors | Drug | Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Variceal Bleeding Events | The primary endpoint was variceal bleeding, which was defined as hematemesis or melena from endoscopically proven GEVs, in the absence of any other lesion that might explain the bleeding. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Prognosis of esophagogastric variceal bleeding. | 8 weeks |
| Adverse Eventsafter Endoscopic Therapy | Advers events caused by endoscopic therapy, including chest pain, dysphagia, fever and so on |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanjing /A Gao, PhD.MD | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology,Qilu Hospital,Shandong University | Jinan | Shandong | 250012 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Proton Pump Inhibitors | Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment. Proton Pump Inhibitors: Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment. |
| FG001 | Placebo | Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment. Placebo: Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Proton Pump Inhibitors | Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment. Proton Pump Inhibitors: Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment. |
| BG001 | Placebo |
| 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 | Variceal Bleeding Events | The primary endpoint was variceal bleeding, which was defined as hematemesis or melena from endoscopically proven GEVs, in the absence of any other lesion that might explain the bleeding. | Posted | Count of Participants | Participants | 8 weeks |
|
8 weeks after endoscopic therapy.
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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 | Proton Pump Inhibitors | Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment. Proton Pump Inhibitors: Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest discomfort | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Gao | Qilu Hospital of Shandong University | +86-531-82169386 | gaoyanjing@sdu.edu.cn |
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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 29, 2020 | May 12, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D006975 | Hypertension, Portal |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D054328 | Proton Pump Inhibitors |
| ID | Term |
|---|---|
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Placebo | Drug | Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment. |
|
|
| 8 weeks |
Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment. Placebo: Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment. |
| 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 |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Mortality | Prognosis of esophagogastric variceal bleeding. | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| Secondary | Adverse Eventsafter Endoscopic Therapy | Advers events caused by endoscopic therapy, including chest pain, dysphagia, fever and so on | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| 1 |
| 53 |
| 0 |
| 53 |
| 15 |
| 53 |
| EG001 | Placebo | Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment. Placebo: Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment. | 0 | 53 | 0 | 53 | 20 | 53 |
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |