A Phase 4 interventional study of Proton Pump Inhibitors and Placebo in Liver Cirrhosis and Hypertension, Portal, sponsored by Yanjing Gao. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-09.
Sponsored by Yanjing Gao · Phase 4, Interventional, and Treatment
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.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's enrollment of 106 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Yanjing Gao is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.
Drug: Proton Pump Inhibitors
Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.
Drug: Placebo
Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.
Also known as: Experimental
Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.
Also known as: Control
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
Mortality
Prognosis of esophagogastric variceal bleeding.
Time frame: 8 weeks
Adverse Eventsafter Endoscopic Therapy
Advers events caused by endoscopic therapy, including chest pain, dysphagia, fever and so on
Time frame: 8 weeks
| Milestone | Proton Pump Inhibitors | Placebo |
|---|---|---|
| Started | 53 | 53 |
| Completed | 46 | 48 |
| Not completed | 7 | 5 |
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.
| Participants | Proton Pump Inhibitors | Placebo |
|---|---|---|
| Variceal Bleeding Events | 3 | 3 |
Prognosis of esophagogastric variceal bleeding.
| Participants | Proton Pump Inhibitors | Placebo |
|---|---|---|
| Mortality | 1 | 0 |
Advers events caused by endoscopic therapy, including chest pain, dysphagia, fever and so on
| Participants | Proton Pump Inhibitors | Placebo |
|---|---|---|
| Adverse Eventsafter Endoscopic Therapy | 15 | 20 |
Collected over 8 weeks after endoscopic therapy.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Proton Pump Inhibitors | 1/53 (1.9%) | 0/53 (0%) | 15/53 (28.3%) |
| Placebo | 0/53 (0%) | 0/53 (0%) | 20/53 (37.7%) |
| Event | Proton Pump Inhibitors | Placebo |
|---|---|---|
| Chest discomfortGastrointestinal disorders | 11/53 | 14/53 |
| DysphagiaGastrointestinal disorders | 4/53 | 6/53 |
| Age, Continuous(years) | Proton Pump Inhibitors | Placebo | Total |
|---|---|---|---|
| Mean | 53.6 ± 10.0 | 54.2 ± 10.6 | 53.8 ± 10.2 |
| Sex: Female, Male(Participants) | Proton Pump Inhibitors | Placebo | Total |
|---|---|---|---|
| Female | 17 | 15 | 32 |
| Male | 36 | 38 | 74 |
| Race and Ethnicity Not Collected(Participants) | Proton Pump Inhibitors | Placebo | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Proton Pump Inhibitors | Placebo | Total |
|---|---|---|---|
| China | 53 | 53 | 106 |
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Yanjing Gao