Hypertension, Portal, Liver Cirrhosis
Conditions
Keywords
Gastroesophageal varices, Hemorrhage
Brief summary
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.
Detailed description
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.
Interventions
DRUGProton Pump Inhibitors
Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.
DRUGPlacebo
Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.
Sponsors
Yanjing Gao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of cirrhosis * GEVs was diagnosed by endoscopy
Exclusion criteria
* Acute gastrointestinal bleeding need emergency surgery * Acid-related disease, such as peptic ulcer disease or gastroesophageal reflux diseases (GERD) * Hepatocellular carcinoma (HCC) or other malignant tumor * History of esophagus, stomach or liver surgery * Child-Pugh C and can't be improved to Child-Pugh A or B * Preparing to be pregnant, pregnant or breast feeding * Allergic to PPIs(proton pump inhibitors) or intolerable * Cannot provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variceal Bleeding Events | 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 8 weeks | Prognosis of esophagogastric variceal bleeding. |
| Adverse Eventsafter Endoscopic Therapy | 8 weeks | Advers events caused by endoscopic therapy, including chest pain, dysphagia, fever and so on |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 53 |
| 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. | 53 |
| Total | 106 |
Baseline characteristics
| Characteristic | Placebo | Total | Proton Pump Inhibitors |
|---|---|---|---|
| Age, Continuous | 54.2 years STANDARD_DEVIATION 10.6 | 53.8 years STANDARD_DEVIATION 10.2 | 53.6 years STANDARD_DEVIATION 10 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment China | 53 participants | 106 participants | 53 participants |
| Sex: Female, Male Female | 15 Participants | 32 Participants | 17 Participants |
| Sex: Female, Male Male | 38 Participants | 74 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 53 | 0 / 53 |
| other Total, other adverse events | 15 / 53 | 20 / 53 |
| serious Total, serious adverse events | 0 / 53 | 0 / 53 |
Outcome results
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.
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Proton Pump Inhibitors | Variceal Bleeding Events | 3 Participants |
| Placebo | Variceal Bleeding Events | 3 Participants |
Secondary
Adverse Eventsafter Endoscopic Therapy
Advers events caused by endoscopic therapy, including chest pain, dysphagia, fever and so on
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Proton Pump Inhibitors | Adverse Eventsafter Endoscopic Therapy | 15 Participants |
| Placebo | Adverse Eventsafter Endoscopic Therapy | 20 Participants |
Secondary
Mortality
Prognosis of esophagogastric variceal bleeding.
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Proton Pump Inhibitors | Mortality | 1 Participants |
| Placebo | Mortality | 0 Participants |