Liver CirrhosisPhase 4PPIsNCT03175731

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

A Phase 4 study testing Proton Pump Inhibitors in people with Liver Cirrhosis and Hypertension, Portal, run by Yanjing Gao at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Liver Cirrhosis, Hypertension, Portal
What is being tested?: Proton Pump Inhibitors
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 106 participants
Where: 1 siteChina
Study dates: 1 May 2017to 30 Aug 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical diagnosis of cirrhosis
GEVs was diagnosed by endoscopy

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

Department of Gastroenterology,Qilu Hospital,Shandong University
Jinan, Shandong, 250012

Other trials in China

About this study

Official title: A Randomized Controlled Study on the Effects of PPIs on Gastroesophageal Variceal Bleeding in Liver Cirrhosis (PPIs: Proton Pump Inhibitors)

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.

Read the 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.

Conditions: Liver Cirrhosis, Hypertension, Portal
Being tested: Proton Pump Inhibitors, Placebo
Keywords: Gastroesophageal varices, Hemorrhage
Medical subject headings: Liver Cirrhosis, Hypertension, Portal, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Proton Pump InhibitorsDrug
Also called Experimental
Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.
PlaceboDrug
Also called Control
Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.

Study groups in NCT03175731
Study group	Role	What they receive
Proton Pump Inhibitors	Experimental	Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment. Receives: Drug: Proton Pump Inhibitors
Placebo	Placebo comparator	Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 8 weeks

Secondary outcomes (2)

Mortality
Prognosis of esophagogastric variceal bleeding.
Measured: 8 weeks
Adverse Eventsafter Endoscopic Therapy
Advers events caused by endoscopic therapy, including chest pain, dysphagia, fever and so on
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 201730 Aug 2019

First posted5 Jun 2017
Study start1 May 2017
Primary completion30 Aug 2019
Study completion30 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Liver CirrhosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03175731
Sponsor's protocol ID: 2017037-QILU
Acronym: PPIs
Status last verified: May 2021
First submitted: 25 May 2017
Last updated: 9 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD

All Liver Cirrhosis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Study on the Effects of PPIs on Gastroesophageal Variceal Bleeding in Liver Cirrhosis (PPIs: Proton Pump Inhibitors)
ClinicalTrials.gov ID: NCT03175731
Acronym / sponsor ID: PPIs / 2017037-QILU
Conditions: Liver Cirrhosis, Hypertension, Portal
Keywords: Gastroesophageal varices, Hemorrhage
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: Yanjing GaoUniversity, hospital or other
Study start: 1 May 2017 (actual)
Primary completion: 30 Aug 2019 (actual)
Study completion: 30 Aug 2019 (actual)
First posted: 5 Jun 2017 (actual)
Results: Posted 9 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Proton Pump Inhibitors	Experimental	Drug: Proton Pump InhibitorsPantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.
Placebo	Placebo comparator	Drug: PlaceboPlacebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Clinical diagnosis of cirrhosis
GEVs was diagnosed by endoscopy

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Proton Pump InhibitorsAlso: ExperimentalPantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.	Drug	Proton Pump Inhibitors
PlaceboAlso: ControlPlacebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.	Drug	Placebo

Primary outcome

Variceal Bleeding Events
Time frame: 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.

2 secondary outcomes

Mortality
Time frame: 8 weeks
Adverse Eventsafter Endoscopic Therapy
Time frame: 8 weeks

Results and safety

Results posted to the registry on 9 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Proton Pump Inhibitors	53	46
Placebo	53	48

Primary outcome: Variceal Bleeding Events

Time frame: 8 weeks. Count of participants. Unit: Participants

Measure	Proton Pump Inhibitors n = 53	Placebo n = 53
Value	3	3

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 weeks after endoscopic therapy.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Proton Pump Inhibitors	0 of 53 (0%)	15 of 53 (28.3%)	1 of 53
Placebo	0 of 53 (0%)	20 of 53 (37.7%)	0 of 53

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Liver Cirrhosis

RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yanjing /A Gao, PhD.MD principal investigator

Qilu Hospital of Shandong University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Proton Pump Inhibitors in people with Liver Cirrhosis and Hypertension, Portal, run by Yanjing Gao at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Variceal Bleeding Events (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03175731.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.