Trial Outcomes & Findings for PPIs and Gastroesophageal Varices in Liver Cirrhosis (PPIs: Proton Pump Inhibitors) (NCT NCT03175731)

NCT ID: NCT03175731

Last Updated: 2021-06-09

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 106 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2021-06-09

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	53	53
Overall Study COMPLETED	46	48
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Proton Pump Inhibitors n=53 Participants 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.	Placebo n=53 Participants 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.	Total n=106 Participants Total of all reporting groups
Age, Continuous	53.6 years STANDARD_DEVIATION 10.0 • n=53 Participants	54.2 years STANDARD_DEVIATION 10.6 • n=53 Participants	53.8 years STANDARD_DEVIATION 10.2 • n=106 Participants
Sex: Female, Male Female	17 Participants n=53 Participants	15 Participants n=53 Participants	32 Participants n=106 Participants
Sex: Female, Male Male	36 Participants n=53 Participants	38 Participants n=53 Participants	74 Participants n=106 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment China	53 participants n=53 Participants	53 participants n=53 Participants	106 participants n=106 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Proton Pump Inhibitors n=53 Participants 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.	Placebo n=53 Participants 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.
Variceal Bleeding Events	3 Participants	3 Participants

SECONDARY outcome

Timeframe: 8 weeks

Prognosis of esophagogastric variceal bleeding.

Outcome measures

Measure	Proton Pump Inhibitors n=53 Participants 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.	Placebo n=53 Participants 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.
Mortality	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 8 weeks

Advers events caused by endoscopic therapy, including chest pain, dysphagia, fever and so on

Outcome measures

Measure	Proton Pump Inhibitors n=53 Participants 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.	Placebo n=53 Participants 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.
Adverse Eventsafter Endoscopic Therapy	15 Participants	20 Participants

Adverse Events

Proton Pump Inhibitors

Serious events: 0 serious events

Other events: 15 other events

Deaths: 1 deaths

Placebo

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Proton Pump Inhibitors n=53 participants at risk 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.	Placebo n=53 participants at risk 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.
Gastrointestinal disorders Chest discomfort	20.8% 11/53 • Number of events 11 • 8 weeks after endoscopic therapy.	26.4% 14/53 • Number of events 14 • 8 weeks after endoscopic therapy.
Gastrointestinal disorders Dysphagia	7.5% 4/53 • Number of events 4 • 8 weeks after endoscopic therapy.	11.3% 6/53 • Number of events 6 • 8 weeks after endoscopic therapy.

Additional Information

Prof. Gao

Qilu Hospital of Shandong University

Phone: +86-531-82169386

Email: gaoyanjing@sdu.edu.cn

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place