PPI Infusion Versus Oral Acid Pump Inhibitors for Bleeding Peptic Ulcers

Launched by CHINESE UNIVERSITY OF HONG KONG · Oct 14, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness of a medication called Vonoprazan (VPZ) compared to standard proton pump inhibitors (PPIs) for treating bleeding peptic ulcers. Peptic ulcers are sores on the lining of the stomach or the first part of the small intestine that can bleed. The study aims to find out if VPZ, which works faster and is more stable in acidic conditions than traditional PPIs, can help prevent further bleeding in patients who have already received treatment to stop the bleeding.

To participate in this trial, individuals must be at least 18 years old and have experienced upper gastrointestinal bleeding due to non-variceal causes, like peptic ulcers. They should have undergone an endoscopy (a procedure where a thin tube with a camera is inserted to look at the digestive tract) and received successful treatment to stop the bleeding. Participants will receive either oral Vonoprazan or the usual high-dose intravenous PPI therapy. Throughout the study, participants will be monitored to see how well each treatment works in preventing recurrent bleeding. If you or someone you know is eligible and interested, this trial could help advance our understanding of treating bleeding peptic ulcers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • - 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
• Exclusion Criteria:
• • 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.