Vonoprazan or Proton-pump inhibitor for gastric endoscopic submucosal dissection in patients under antithrombotic therapy: a randomized prospective multicenter study

UMIN ID: UMIN000040641

Registered date:03/06/2020

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: gastric epithelial neoplasms
• Date of first enrollment: 2020/09/16
• Target sample size: 124
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Patients will be randomly allocated to either VPZ or PPI group. In the PPI group, esomeprazole 20mg will be administered orally from the day before ESD to 54 days after ESD.
VPZ 20mg will be administered orally from the day before ESD to 54 days after ESD.

Outcome(s)

• Primary Outcome: Incidence of bleeding within 8 weeks after ESD.
• Secondary Outcome: 1. Frequency of GERD-like symptoms after ESD. 2. Frequency of pain after ESD. 3. Healing of the ulcer at 8 weeks after ESD. 4. Adverse events related to ESD.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. Those with simultaneous esophageal or duodenal endoscopic treatment. 2. Endoscopic treatment for upper digestive tract within 31 days before ESD. 3. Women with pregnancy, 4. Psychological disorders. 5. Presence of active infectious diseases. 6. Impossible to answer to F-Scale or VAS. 7. Allergy to VPZ or EPZ.

Related Information

• Primary Sponsor: Nagoya University
• Source(s) of Monetary Support: No funding source.