Actively Recruiting
A Comparison Between a High Dose PPI Intravenous Infusion and Oral Acid Pump Inhibitors After Endoscopic Haemostasis to Bleeding Peptic Ulcers
Led by Chinese University of Hong Kong · Updated on 2026-03-18
594
Participants Needed
8
Research Sites
26 weeks
Total Duration
On this page
Sponsors
C
Chinese University of Hong Kong
Lead Sponsor
N
Nanfang Hospital, Southern Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of oral Vonoprazan, a potassium-competitive acid blocker, compared to standard high dose proton pump inhibitor (PPI) therapy for patients with bleeding peptic ulcers who have received successful endoscopic haemostasis. This multicenter randomized controlled trial aims to determine whether Vonoprazan is not worse than the standard intravenous PPI infusion at preventing recurrent bleeding within 30 days. Upper gastrointestinal bleeding remains a serious condition, and effective acid suppression helps stabilize clots and prevent further bleeding. Participants will be randomly assigned to receive either a high dose PPI infusion consisting of an 80mg intravenous bolus of esomeprazole followed by continuous infusion at 8mg per hour for 72 hours, or oral Vonoprazan at 40mg twice daily for 72 hours followed by 20mg daily from day 4 to day 30. The study compares these two acid suppression methods after endoscopic treatment to assess their effects on recurrent bleeding and related outcomes. During the study, participants will be monitored for recurrent bleeding, need for additional hemostatic treatment, and length of hospital and intensive care stay within 30 days after randomization. Researchers will also investigate Vonoprazan's effect on intragastric pH in this clinical setting. The total participation time includes treatment and follow-up assessments extending to 30 days after starting the assigned therapy.
CONDITIONS
Brief Title
PPI Infusion Versus Oral Acid Pump Inhibitors for Bleeding Peptic Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Patients who had an oesophagogastroduodenoscopy for signs or symptoms of anemia or upper GI bleeding such as hematochezia, melena, or hematemesis
- Diagnosis of non-variceal upper GI bleeding causes including peptic ulcers, Dieulafoy's lesions, or Mallory Weiss tear with active bleeding or major stigmata of hemorrhage
- Presence of major stigmata of recent hemorrhage such as peptic ulcers with spurting or oozing bleeding (Forrest Ia and Ib), nonbleeding visible vessel (Forrest IIa), or an adherent clot (Forrest IIb) where clot removal reveals active bleeding or visible vessel
- Patients who have undergone successful endoscopic hemostatic treatment with no evidence of bleeding after irrigation and 3 minutes of observation
You will not qualify if you...
- Patients who do not consent to participate
- Patients under 18 years of age
- Pregnant or lactating individuals
- Known hypersensitivity to proton pump inhibitors, Vonoprazan, or any component of the formulations
- Patients with bleeding caused by tumors or esophageal varices
- Non-variceal upper GI bleeding due to post-therapeutic endoscopic procedures such as gastric polypectomy, endoscopic mucosal resection, or submucosal dissection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 30 days
Participants receive either a high dose esomeprazole intravenous infusion or oral Vonoprazan following successful endoscopic haemostasis for bleeding peptic ulcers.
Initial 72 hours of infusion or oral medication followed by oral medication from day 4 to day 30
Trial Site Locations
Total: 8 locations
1
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, China
Actively Recruiting
2
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Not Yet Recruiting
3
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
Not Yet Recruiting
4
Shenzhen Pingshan District People's Hospital
Shenzhen, Guangdong, China
Not Yet Recruiting
5
The Second Affiliated Hospital The Chinese University of Hong Kong, Shenzhen & Longgang District People's Hospital of Shenzhen
Shenzhen, Guangdong, China
Not Yet Recruiting
6
Yangjiang People's Hospital of Guangdong Medical University
Yangjiang, Guangdong, China
Not Yet Recruiting
7
Zhuhai People's Hospital (Zhuhai Hospital Affiliated to Jinan University)
Zhuhai, Guangdong, China
Not Yet Recruiting
8
Prince of Wales Hospital
Hong Kong, Hong Kong SAR, China
Not Yet Recruiting
Research Team
X
xiaobei luo, PhD
B
bingyee suen, Bachelor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here