A Comparison Between a High Dose PPI Intravenous Infusion and Oral Acid Pump Inhibitors After Endoscopic Haemostasis to Bleeding Peptic Ulcers

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• \- 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

Locations
Other Locations
China
Nanfang Hospital Southern Medical University
RECRUITING
Guangzhou
The Second Affiliated Hospital of Guangzhou Medical University
NOT_YET_RECRUITING
Guangzhou
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
NOT_YET_RECRUITING
Guangzhou
Prince of Wales Hospital
NOT_YET_RECRUITING
Hong Kong
Shenzhen Pingshan District People's Hospital
NOT_YET_RECRUITING
Shenzhen
The Second Affiliated Hospital The Chinese University of Hong Kong, Shenzhen & Longgang District People's Hospital of Shenzhen
NOT_YET_RECRUITING
Shenzhen
Yangjiang People's Hospital of Guangdong Medical University
NOT_YET_RECRUITING
Yangjiang
Zhuhai People's Hospital (Zhuhai Hospital Affiliated to Jinan University)
NOT_YET_RECRUITING
Zhuhai
Contact Information
Primary
xiaobei luo, PhD
luoxiaobei63@126.com
86 17688881428
Backup
bingyee suen, Bachelor
bingyeesuen@surgery.cuhk.edu.hk
35052640
Time Frame
Start Date: 2023-05-18
Estimated Completion Date: 2026-01-03
Participants
Target number of participants: 594
Treatments
Active_comparator: PPI infusion
esomeprazole 80mg iv bolus followed by 8mg per hour for 72 hours
Experimental: Vonoprazan
Vonoprazan 40 mg bid orally for 72 hours, and from day 4-30 VPZ 20 mg daily
Related Therapeutic Areas
Sponsors
Collaborators: Nanfang Hospital, Southern Medical University
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov