PPI Infusion Versus Oral Acid Pump Inhibitors for Bleeding Peptic Ulcers
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
- 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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Vonoprazan
DrugVonoprazan 40 mg bid orally for 72 hours, and from day 4-30 VPZ 20 mg daily
esomeprazole
DrugA high dose PPI infusion (esomeprazole 80mg iv bolus followed by 8mg per hour for 72 hours), and frorm day 4-30 oral esomeprazole daily
Treatment groups
594 Participants
are divided into 2 treatment groupsGroup A: PPI infusionActive comparator 1 intervention
Group B: VonoprazanExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The number of recurrent bleeding
The number of recurrent bleeding that occurred after 1st endoscopic hemostasis and confirmed by endoscopy
Time frame
within 30 days after randomizationSecondary outcomes
1
further treatment for hemostasis
the rate of patients that required endoscopic treatment/surgery/embolization for hemostasis
Time frame
within 30 days after randomization2
Total Days of hospital stay and intensive unit stay
hospital stays and intensive unit stays
Time frame
within 30 days after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Chinese University of Hong Kong
Lead sponsor
Nanfang Hospital, Southern Medical University
Collaborator
Source ClinicalTrials.gov