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PPIs and Gastroesophageal Varices in Liver Cirrhosis (PPIs: Proton Pump Inhibitors) (PPIs)

Primary Purpose

Liver Cirrhosis, Hypertension, Portal

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Proton Pump Inhibitors
Placebo
Sponsored by
Yanjing Gao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring Gastroesophageal varices, Hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Gastroenterology,Qilu Hospital,Shandong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Proton Pump Inhibitors

Placebo

Arm Description

Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.

Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mortality
Prognosis of esophagogastric variceal bleeding.
Adverse Eventsafter Endoscopic Therapy
Advers events caused by endoscopic therapy, including chest pain, dysphagia, fever and so on

Full Information

First Posted
May 25, 2017
Last Updated
May 13, 2021
Sponsor
Yanjing Gao
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1. Study Identification

Unique Protocol Identification Number
NCT03175731
Brief Title
PPIs and Gastroesophageal Varices in Liver Cirrhosis (PPIs: Proton Pump Inhibitors)
Acronym
PPIs
Official Title
A Randomized Controlled Study on the Effects of PPIs on Gastroesophageal Variceal Bleeding in Liver Cirrhosis (PPIs: Proton Pump Inhibitors)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yanjing Gao

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Hypertension, Portal
Keywords
Gastroesophageal varices, Hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Proton Pump Inhibitors
Arm Type
Experimental
Arm Description
Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.
Intervention Type
Drug
Intervention Name(s)
Proton Pump Inhibitors
Other Intervention Name(s)
Experimental
Intervention Description
Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Control
Intervention Description
Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.
Primary Outcome Measure Information:
Title
Variceal Bleeding Events
Description
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
Secondary Outcome Measure Information:
Title
Mortality
Description
Prognosis of esophagogastric variceal bleeding.
Time Frame
8 weeks
Title
Adverse Eventsafter Endoscopic Therapy
Description
Advers events caused by endoscopic therapy, including chest pain, dysphagia, fever and so on
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanjing /A Gao, PhD.MD
Organizational Affiliation
Qilu Hospital, Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology,Qilu Hospital,Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

PPIs and Gastroesophageal Varices in Liver Cirrhosis (PPIs: Proton Pump Inhibitors)

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