PPI Infusion Versus Oral Acid Pump Inhibitors for Bleeding Peptic Ulcers

Recruiting now · Phase 4

Conditions studied: Upper GI Bleeding, Proton Pump Inhibitors

In brief

Vonoprazan (VPZ), an oral potassium-competitive acid blocker (P-CAB) has emerged as an alternative potent acid-suppressant.It has a faster onset of action in 1 day (3-5 days in PPI), and is more stable in acidic condition than PPI. While many studies compared Vonoprazan against PPI in the treatment of reflux oesophagitis, H. Pylori eradication, and gastric ulcers; thus far, there is a paucity of data on use of Vonoprazan on bleeding peptic ulcers. We perform a multicenter randomized controlled trial (RCT) to compare the efficacy of oral Vonoprazan against standard high dose PPI therapy in bleeding peptic ulcers that had received successful endoscopic haemostasis We hypothesize that in patients with bleeding peptic ulcers, the use of acid pump inhibitors Vonoprazan would not be inferior to standard treatment of a bolus plus high dose PPI intravenous infusion at preventing recurrent bleeding after endoscopic haemostasis.

Key facts

Study ID

NCT05582174

Run by

Chinese University of Hong Kong

People needed

594

Starts

2023-05-18

Expected to finish

2028-07-03

Last updated by the study team

2026-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• - Patients aged ≥18 years who had undergone oesophagogastroduodenoscopy (OGD) for sign and symptoms of aneamia or upper GI bleeding including haematochezia, melaena or haematemesis, and found to a non-variceal upper GI cause of bleeding (peptic ulcers, dieulafoy's lesions, Mallory Weiss tear with active bleeding or major stigmata of haemorrhage
• Major stigmata of recent haemorrhage includes peptic ulcers with spurting or oozing bleeding (Forrest classification Ia and Ib, respectively) ,with a nonbleeding visible vessel (Forrest classification IIa) or an adherent clot (Forrest classification IIb). For peptic ulcers with an adherent clot (Forrest classification IIb), the clot would be lifted (by irrigation using syringe boluses or water pump device, or manipulation with a snare or alligator etc.) and ulcer base examined to look for underlying vessels. Once the clot is removed, any identified underlying active bleeding or nonbleeding visible vessel should receive endoscopic haemostasis
• Patients who had undergone endoscopic hemostatic treatment (a combination of hemoclipping therapy or contact thermocoagulation using multipolar/bipolar electrocautery probes or haemostatic forceps, with or without preinjection of diluted epinephrine. Endoscopic haemostasis is defined as no evidence of bleeding after irrigation and 3 minutes of observation

You may not qualify if…

• No consent
• Patients under the age of 18
• Patients who were pregnant or in lactation
• Hypersensitivity to PPI or Vonoprazan or any component of the formulation
• Patients who were found to have tumour bleeding, oesophageal varices as the cause of the NVGIB
• NVGIB due to post therapeutic endoscopic treatment such as gastric polypectomy, endoscopic mucosal resection, endoscopic submucosal dissection etc.

Where it is running

• Nanfang Hospital Southern Medical University — Guangzhou, Guangdong, China (enrolling)
• The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China
• The Second Affiliated Hospital of Guangzhou University of Chinese Medicine — Guangzhou, Guangdong, China
• Shenzhen Pingshan District People's Hospital — Shenzhen, Guangdong, China
• The Second Affiliated Hospital The Chinese University of Hong Kong, Shenzhen & Longgang District People's Hospital of Shenzhen — Shenzhen, Guangdong, China
• Yangjiang People's Hospital of Guangdong Medical University — Yangjiang, Guangdong, China
• Zhuhai People's Hospital (Zhuhai Hospital Affiliated to Jinan University) — Zhuhai, Guangdong, China
• Prince of Wales Hospital — Hong Kong, Hong Kong SAR, China

Full record on ClinicalTrials.gov

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